Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT00773734
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2008-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505730', 'term': 'apremilast'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialdisclosure@celgene.com', 'phone': '888-243-1360', 'title': 'Anne McClain', 'organization': 'Celgene Corporation'}, 'certainAgreement': {'otherDetails': 'Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events are reported for the 16-week placebo-controlled phase and up to the LTE period, (6 years) for all participants who were randomized or re-randomized to apremilast at any time during the core, the extension or the long term extension study.', 'description': 'Participants initially randomized to 10 mg PO BID were re-randomized at Week 52 to either 20 mg BID or 30 mg BID are included in the 10 mg BID group. Numbers of participants affected by serious adverse events were summarized. Some participants had more than one serious adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (Weeks 0-16)', 'description': 'Participants randomized to placebo PO BID during the Placebo-controlled Phase', 'otherNumAtRisk': 88, 'otherNumAffected': 35, 'seriousNumAtRisk': 88, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Apremilast 10mg BID (Weeks 0-16)', 'description': 'Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).', 'otherNumAtRisk': 89, 'otherNumAffected': 42, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Apremilast 20mg BID (Weeks 0-16)', 'description': 'Participants randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)', 'otherNumAtRisk': 87, 'otherNumAffected': 45, 'seriousNumAtRisk': 87, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Apremilast 30mg BID (Weeks 0-16)', 'description': 'Participants randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16)', 'otherNumAtRisk': 88, 'otherNumAffected': 55, 'seriousNumAtRisk': 88, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Apremilast 10mg BID (APR Exposure Period) Years 0-6', 'description': 'Participants initially randomized to 10 mg PO BID apremilast at Week 0. Participants who were dosed with apremilast 10mg BID in the extension study were randomly assigned to either apremilast 20 mg or 30 mg BID in the long term extension study (LTE).', 'otherNumAtRisk': 89, 'otherNumAffected': 52, 'seriousNumAtRisk': 89, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Apremilast 20mg BID (APR Exposure Period) Years 0-6', 'description': 'Participants who received 20 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.', 'otherNumAtRisk': 121, 'otherNumAffected': 66, 'seriousNumAtRisk': 121, 'seriousNumAffected': 9}, {'id': 'EG006', 'title': 'Apremilast 30mg BID (APR Exposure Period) Years 0-6', 'description': 'Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16 or Week 52), up to 6 years.', 'otherNumAtRisk': 124, 'otherNumAffected': 85, 'seriousNumAtRisk': 124, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 19}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 121, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '11.2', 'groupId': 'OG001'}, {'value': '28.7', 'groupId': 'OG002'}, {'value': '40.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1846', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '13.7', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.1', 'ciLowerLimit': '12.4', 'ciUpperLimit': '33.7', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.2', 'ciLowerLimit': '23.9', 'ciUpperLimit': '46.6', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 and Week 16', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 10 mg BID PO during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg PO BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID PO during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '27.5'}, {'value': '26.4', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '37.0'}, {'value': '39.8', 'groupId': 'OG002', 'lowerLimit': '29.5', 'upperLimit': '50.8'}, {'value': '41.2', 'groupId': 'OG003', 'lowerLimit': '24.6', 'upperLimit': '59.3'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '27.9', 'upperLimit': '61.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 24', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at Week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '38.2', 'groupId': 'OG001'}, {'value': '47.1', 'groupId': 'OG002'}, {'value': '60.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '26.8', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.1', 'ciLowerLimit': '8.3', 'ciUpperLimit': '36.0', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.2', 'ciLowerLimit': '21.6', 'ciUpperLimit': '48.9', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg', 'description': 'Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).'}], 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000', 'lowerLimit': '28.1', 'upperLimit': '49.1'}, {'value': '49.4', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '60.4'}, {'value': '65.9', 'groupId': 'OG002', 'lowerLimit': '55.0', 'upperLimit': '75.7'}, {'value': '61.8', 'groupId': 'OG003', 'lowerLimit': '43.6', 'upperLimit': '77.8'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '57.8', 'upperLimit': '87.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 24', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '9.2', 'groupId': 'OG002'}, {'value': '11.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '8.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.1', 'ciLowerLimit': '1.6', 'ciUpperLimit': '14.5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0051', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.2', 'ciLowerLimit': '3.2', 'ciUpperLimit': '17.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg', 'description': 'Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 30 mg', 'description': 'Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG003', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '11.1'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '15.9'}, {'value': '14.8', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '23.9'}, {'value': '14.7', 'groupId': 'OG003', 'lowerLimit': '5.0', 'upperLimit': '31.1'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '6.4', 'upperLimit': '32.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 24', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'timeFrame': 'Week 0 to Week 16', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'reportingStatus': 'POSTED', 'populationDescription': 'The PASI 100 was not defined and analyzed since there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to APR 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg tablets BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to identically matching placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).'}], 'timeFrame': 'Week 0 to Week 24', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'reportingStatus': 'POSTED', 'populationDescription': 'The PASI 100 was not defined and analyzed since there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'timeFrame': 'Weeks 0 to 16', 'description': 'For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to achieve PASI 100 was not defined or analyzed as there were too few participants.'}, {'type': 'SECONDARY', 'title': 'Core Study: Percent Change From Baseline in PASI Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16). .'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.3', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '-34.0', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '-45.4', 'spread': '4.12', 'groupId': 'OG002'}, {'value': '-53.2', 'spread': '4.00', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-24.8', 'ciUpperLimit': '-2.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.1', 'ciLowerLimit': '-36.4', 'ciUpperLimit': '-13.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.9', 'ciLowerLimit': '-44.0', 'ciUpperLimit': '-21.7', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 16', 'description': 'The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Percent Change From Baseline in PASI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24'}, {'id': 'OG004', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.3', 'spread': '36.03', 'groupId': 'OG000'}, {'value': '-46.5', 'spread': '36.08', 'groupId': 'OG001'}, {'value': '-56.8', 'spread': '34.99', 'groupId': 'OG002'}, {'value': '-61.7', 'spread': '25.35', 'groupId': 'OG003'}, {'value': '-61.7', 'spread': '32.67', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 24', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg', 'description': 'Participants were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG003', 'title': 'Apremilast 30 mg', 'description': 'Participants were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '33.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '7.3', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0402', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.4', 'ciLowerLimit': '0.6', 'ciUpperLimit': '24.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.1', 'ciLowerLimit': '8.8', 'ciUpperLimit': '33.4', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '22.4'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '34.5'}, {'value': '34.1', 'groupId': 'OG002', 'lowerLimit': '24.3', 'upperLimit': '45.0'}, {'value': '41.2', 'groupId': 'OG003', 'lowerLimit': '24.6', 'upperLimit': '59.3'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '32.9', 'upperLimit': '67.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 and Week 24', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at Week 16; Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 10 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'timeFrame': 'Week 0 to Week 16', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See other pre-specified outcome measures.'}, {'type': 'SECONDARY', 'title': 'Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 24', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.'}, {'type': 'SECONDARY', 'title': 'Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.0', 'spread': '4.58', 'groupId': 'OG000'}, {'value': '-28.3', 'spread': '4.60', 'groupId': 'OG001'}, {'value': '-38.0', 'spread': '4.74', 'groupId': 'OG002'}, {'value': '-50.4', 'spread': '4.63', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.2', 'ciLowerLimit': '-33.0', 'ciUpperLimit': '-7.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.9', 'ciLowerLimit': '-42.9', 'ciUpperLimit': '-17.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.4', 'ciLowerLimit': '-55.2', 'ciUpperLimit': '-29.5', 'pValueComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 16', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.1', 'spread': '46.78', 'groupId': 'OG000'}, {'value': '-40.6', 'spread': '43.71', 'groupId': 'OG001'}, {'value': '-54.0', 'spread': '37.32', 'groupId': 'OG002'}, {'value': '-52.5', 'spread': '37.35', 'groupId': 'OG003'}, {'value': '-54.2', 'spread': '42.08', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 24', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '83', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '0.63', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '-2.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '0.0047', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '-0.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 16', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast (APR) 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '6.53', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '5.18', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '6.64', 'groupId': 'OG003'}, {'value': '-5.4', 'spread': '5.32', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 24', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '0.89', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0078', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '0.0068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '1.0', 'ciUpperLimit': '6.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '0.0045', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '1.1', 'ciUpperLimit': '6.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to Week 16', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '0.80', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '0.2424', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}, {'pValue': '0.9528', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '2.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0 to week 16', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population = all randomized participants. Last observation carried forward (LOCF) method was used for imputing missing values'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '9.16', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '9.56', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '10.22', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '10.96', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '9.17', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '8.29', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '7.72', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '9.34', 'groupId': 'OG003'}, {'value': '2.7', 'spread': '8.24', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1008', 'spread': '35.8', 'groupId': 'OG000'}, {'value': '1591', 'spread': '56.9', 'groupId': 'OG001'}, {'value': '3467', 'spread': '20.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast', 'description': 'Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo'}, {'type': 'SECONDARY', 'title': 'Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg', 'description': 'Participants who were initially randomized to apremilast 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 20 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 30 mg', 'description': 'Participants who were initially randomized to apremilast 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 30 mg BID during the Active Treatment Phase (Weeks 16-24).'}], 'classes': [{'categories': [{'measurements': [{'value': '1200', 'spread': '44.6', 'groupId': 'OG000'}, {'value': '1257', 'spread': '47.1', 'groupId': 'OG001'}, {'value': '3477', 'spread': '29.3', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 24', 'description': 'Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.'}, {'type': 'SECONDARY', 'title': 'Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '209', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '298', 'spread': '48.3', 'groupId': 'OG001'}, {'value': '637', 'spread': '18.7', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast', 'description': 'The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo'}, {'type': 'SECONDARY', 'title': 'Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '238', 'spread': '45.2', 'groupId': 'OG000'}, {'value': '236', 'spread': '39.7', 'groupId': 'OG001'}, {'value': '670', 'spread': '20.4', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 24', 'description': 'The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo.'}, {'type': 'SECONDARY', 'title': 'Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast', 'description': 'Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo'}, {'type': 'SECONDARY', 'title': 'Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 24', 'description': 'Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population; samples were not obtained from participants who were randomized to placebo'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '28.3'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '36.0'}, {'value': '36.2', 'groupId': 'OG002', 'lowerLimit': '24.0', 'upperLimit': '49.0'}, {'value': '37.0', 'groupId': 'OG003', 'lowerLimit': '19.4', 'upperLimit': '57.6'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '16.5', 'upperLimit': '54.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '42.6'}, {'value': '38.0', 'groupId': 'OG001', 'lowerLimit': '24.7', 'upperLimit': '52.8'}, {'value': '46.6', 'groupId': 'OG002', 'lowerLimit': '33.3', 'upperLimit': '60.1'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '16.5', 'upperLimit': '54.0'}, {'value': '55.6', 'groupId': 'OG004', 'lowerLimit': '35.3', 'upperLimit': '74.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 32', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '35.7'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '42.5'}, {'value': '34.5', 'groupId': 'OG002', 'lowerLimit': '22.5', 'upperLimit': '48.1'}, {'value': '37.0', 'groupId': 'OG003', 'lowerLimit': '19.4', 'upperLimit': '57.6'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '25.5', 'upperLimit': '64.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 40', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '71.7'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '57.5', 'upperLimit': '83.8'}, {'value': '86.2', 'groupId': 'OG002', 'lowerLimit': '74.6', 'upperLimit': '93.9'}, {'value': '74.1', 'groupId': 'OG003', 'lowerLimit': '53.7', 'upperLimit': '88.9'}, {'value': '74.1', 'groupId': 'OG004', 'lowerLimit': '53.7', 'upperLimit': '88.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 32', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '63.9'}, {'value': '62.0', 'groupId': 'OG001', 'lowerLimit': '47.2', 'upperLimit': '75.3'}, {'value': '82.8', 'groupId': 'OG002', 'lowerLimit': '70.6', 'upperLimit': '91.4'}, {'value': '63.0', 'groupId': 'OG003', 'lowerLimit': '42.4', 'upperLimit': '80.6'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '46.0', 'upperLimit': '83.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 40', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '57.8'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '33.7', 'upperLimit': '62.6'}, {'value': '72.4', 'groupId': 'OG002', 'lowerLimit': '59.1', 'upperLimit': '83.6'}, {'value': '55.6', 'groupId': 'OG003', 'lowerLimit': '35.3', 'upperLimit': '74.5'}, {'value': '48.1', 'groupId': 'OG004', 'lowerLimit': '28.7', 'upperLimit': '68.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '23.1'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '26.7'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '31.4'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '38.1'}, {'value': '25.9', 'groupId': 'OG004', 'lowerLimit': '11.1', 'upperLimit': '46.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 32', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '20.4'}, {'value': '14.0', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '26.7'}, {'value': '17.2', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '29.4'}, {'value': '18.5', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '38.1'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '8.6', 'upperLimit': '42.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 40', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '14.5'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '21.8'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '25.4'}, {'value': '14.8', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '33.7'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '29.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat; Non-responder imputation'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 32', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'reportingStatus': 'POSTED', 'populationDescription': 'The PASI 100 was not defined and analyzed since there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 40', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'reportingStatus': 'POSTED', 'populationDescription': 'The PASI 100 was not defined and analyzed since there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 52', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'reportingStatus': 'POSTED', 'populationDescription': 'The PASI 100 was not defined and analyzed since there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Time to Achieve PASI-75 During the Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 52', 'description': 'For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to achieve PASI-75 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study'}, {'type': 'SECONDARY', 'title': 'Extension Study: Time to Achieve PASI-50 During the Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 52', 'description': 'For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to achieve PASI-50 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study'}, {'type': 'SECONDARY', 'title': 'Extension Study: Time to Achieve PASI-90 During the Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Extension study', 'description': 'For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to achieve PASI-90 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study'}, {'type': 'SECONDARY', 'title': 'Extension Study: Time to Achieve PASI-100 During the Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Extension Study', 'description': 'For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to achieve PASI-100 score was not defined and analyzed as there were too few such participants who did not achieve responses in the core study but achieved in the extension study'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '38.0'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '40.3'}, {'value': '44.8', 'groupId': 'OG002', 'lowerLimit': '31.7', 'upperLimit': '58.5'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '16.5', 'upperLimit': '54.0'}, {'value': '59.3', 'groupId': 'OG004', 'lowerLimit': '38.8', 'upperLimit': '77.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 32', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '38.0'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '31.4'}, {'value': '29.3', 'groupId': 'OG002', 'lowerLimit': '18.1', 'upperLimit': '42.7'}, {'value': '29.6', 'groupId': 'OG003', 'lowerLimit': '13.8', 'upperLimit': '50.2'}, {'value': '37.0', 'groupId': 'OG004', 'lowerLimit': '19.4', 'upperLimit': '57.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 40', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; Intent to Treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '25.7'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '21.8'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '12.5', 'upperLimit': '35.3'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '16.5', 'upperLimit': '54.0'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '8.6', 'upperLimit': '42.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 52', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study; LOCF was used.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percent Change in PASI Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-51.0', 'spread': '34.10', 'groupId': 'OG000'}, {'value': '-63.1', 'spread': '27.01', 'groupId': 'OG001'}, {'value': '-72.7', 'spread': '20.97', 'groupId': 'OG002'}, {'value': '-64.0', 'spread': '25.16', 'groupId': 'OG003'}, {'value': '-69.2', 'spread': '27.60', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 32', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had PASI assessment at Week 32; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percent Change in PASI Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.9', 'spread': '29.63', 'groupId': 'OG000'}, {'value': '-63.3', 'spread': '27.26', 'groupId': 'OG001'}, {'value': '-71.1', 'spread': '18.91', 'groupId': 'OG002'}, {'value': '-64.5', 'spread': '27.05', 'groupId': 'OG003'}, {'value': '-71.7', 'spread': '24.53', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 40', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had PASI assessment at Week 40; Intent to Treat;'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percent Change in PASI Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.1', 'spread': '23.50', 'groupId': 'OG000'}, {'value': '-58.9', 'spread': '30.65', 'groupId': 'OG001'}, {'value': '-65.3', 'spread': '29.86', 'groupId': 'OG002'}, {'value': '-62.7', 'spread': '29.49', 'groupId': 'OG003'}, {'value': '-62.0', 'spread': '28.28', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 52', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had PASI assessment at Week 52; Intent to Treat;'}, {'type': 'SECONDARY', 'title': 'Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 32', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 40', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 52', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint. See pre-specified outcome measures.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percent Change From Baseline in the Affected BSA at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-47.1', 'spread': '45.62', 'groupId': 'OG000'}, {'value': '-65.1', 'spread': '30.42', 'groupId': 'OG001'}, {'value': '-75.3', 'spread': '20.19', 'groupId': 'OG002'}, {'value': '-62.6', 'spread': '29.48', 'groupId': 'OG003'}, {'value': '-66.7', 'spread': '34.50', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 32', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had a BSA assessment at Week 32; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percent Change From Baseline in the Affected BSA at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.4', 'spread': '33.33', 'groupId': 'OG000'}, {'value': '-65.4', 'spread': '27.33', 'groupId': 'OG001'}, {'value': '-74.3', 'spread': '17.98', 'groupId': 'OG002'}, {'value': '-66.2', 'spread': '27.19', 'groupId': 'OG003'}, {'value': '-68.0', 'spread': '32.83', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 40', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had BSA assessment at Week 40; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percent Change From Baseline in the Affected BSA at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-53.1', 'spread': '30.33', 'groupId': 'OG000'}, {'value': '-58.3', 'spread': '48.88', 'groupId': 'OG001'}, {'value': '-67.3', 'spread': '32.56', 'groupId': 'OG002'}, {'value': '-67.4', 'spread': '28.29', 'groupId': 'OG003'}, {'value': '-64.9', 'spread': '31.26', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 52', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had BSA assessment at Week 52; Intent to Treat;'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5', 'spread': '6.13', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '6.20', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '5.02', 'groupId': 'OG002'}, {'value': '-8.1', 'spread': '7.16', 'groupId': 'OG003'}, {'value': '5.5', 'spread': '5.63', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 32', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had DLQI assessment at Week 32; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '5.92', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '4.51', 'groupId': 'OG002'}, {'value': '-7.1', 'spread': '7.54', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '5.03', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 40', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.8', 'spread': '7.11', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '5.14', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '4.72', 'groupId': 'OG002'}, {'value': '-6.8', 'spread': '7.16', 'groupId': 'OG003'}, {'value': '-4.9', 'spread': '5.05', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 52', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had DLQI assessment at Week 40; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '8.26', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '7.80', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '11.93', 'groupId': 'OG003'}, {'value': '2.8', 'spread': '9.64', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 32', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '6.67', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '7.58', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '9.44', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '8.46', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 32', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had SF-36 assessment at Week 32; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '10.64', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '8.95', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '7.18', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '12.24', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '8.71', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 40', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '7.77', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '7.34', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '10.89', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '6.20', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 40', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had SF-36 assessment at Week 40; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '11.56', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '9.81', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '7.91', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '12.18', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '7.49', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 52', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat;'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '7.79', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '5.50', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '6.81', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '12.84', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '6.90', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Week 52', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value..', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who entered the extension study and had SF-36 assessment at Week 52; Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 52', 'description': 'Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0', 'reportingStatus': 'POSTED', 'populationDescription': 'The dose-response relationship analysis was anticipated, however, since the extension study was optional and there was not placebo control, no formal testing of dose response was conducted'}, {'type': 'SECONDARY', 'title': 'Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to 52', 'description': 'Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint was not summarized since the time of the maximal improvement is variable and the maximal improvement could occur in either the core phase or the extension phase'}, {'type': 'SECONDARY', 'title': 'Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.3', 'comment': 'Not Available: the median and the limits of Confidence Interval (CI) could not be calculated due to insufficient number of participants who lost effect during the Observational Follow-up Phase.', 'groupId': 'OG004', 'lowerLimit': '5.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 4 weeks after the last dose', 'description': 'Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who entered the observational follow-up phase and were PASI-50 responders at the beginning of the time interval.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'title': 'Any treatment emergent AE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'Any drug-related TEAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Any serious drug-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '≥ 1 TEAE leading to drug interruption', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': '≥ 1 TEAE leading to drug withdrawal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': '≥ 1 TEAE leading to death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 16; up to data cut off of 21 July 2011', 'description': "An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who were randomized and received at least one dose of Investigational Product (IP)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'title': 'Any treatment emergent AE', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}, {'title': 'Any drug-related TEAE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any serious drug-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE leading to drug interruption', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE leading to drug withdrawal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0-88; up to data cut off of 21 July 2011', 'description': "An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all participants who were treated with Apremilast'}, {'type': 'SECONDARY', 'title': 'Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '16.9'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '16.7'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '16.4'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '16.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 to 16', 'description': 'For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes PASI-50 responders during the placebo controlled phase'}, {'type': 'SECONDARY', 'title': 'Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': '.Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '17.1'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '16.0'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '17.0'}, {'value': '6.3', 'groupId': 'OG003', 'lowerLimit': '3.7', 'upperLimit': '16.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0 to 16', 'description': 'For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes PASI-75 responders during the placebo controlled phase.'}, {'type': 'SECONDARY', 'title': 'Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo BID', 'description': 'Participants were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'OG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'timeFrame': 'Weeks 0 to 16', 'description': 'For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to achieve PASI-90 was not defined or analyzed as there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) continued dosing with apremilast 10mg PO BID through Week 52 of the extension phase. Participants who received 10mg PO BID at the end of the extension study were randomly assigned to apremilast 20 mg or 30 mg PO BID during the long term extension study. (LTE).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'title': 'Any treatment emergent AE', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}]}, {'title': 'Any drug-related TEAE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Any serious drug-related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE leading to drug interruption', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE leading to drug withdrawal', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': '≥ 1 TEAE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks', 'description': "An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: includes all participants who were treated with Apremilast'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '40.0', 'groupId': 'OG002', 'lowerLimit': '12.2', 'upperLimit': '73.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '18.7', 'upperLimit': '81.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 18', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; participants who entered the long-term extension study'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '18.7', 'upperLimit': '81.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 24', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; participants who entered the long-term extension study'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 36', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '70.0', 'groupId': 'OG002', 'lowerLimit': '34.8', 'upperLimit': '93.3'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 18', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '18.7', 'upperLimit': '81.3'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '90.0', 'groupId': 'OG004', 'lowerLimit': '55.5', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 24', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '6.7', 'upperLimit': '65.2'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '60.0', 'groupId': 'OG004', 'lowerLimit': '26.2', 'upperLimit': '87.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 36', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '12.2', 'upperLimit': '73.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 18', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 24', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '20.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '55.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 36', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '52.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '20.0', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '55.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).', 'reportingStatus': 'POSTED', 'populationDescription': 'The PASI 100 was not defined and analyzed since there were too few such participants.'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in PASI Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-71.8', 'spread': '14.84', 'groupId': 'OG000'}, {'value': '-60.5', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '-65.3', 'spread': '21.28', 'groupId': 'OG002'}, {'value': '-50.0', 'spread': '12.83', 'groupId': 'OG003'}, {'value': '-77.3', 'spread': '17.77', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 18', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in PASI Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.8', 'spread': '19.51', 'groupId': 'OG000'}, {'value': '-64.5', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '-65.9', 'spread': '21.22', 'groupId': 'OG002'}, {'value': '-46.0', 'spread': '23.11', 'groupId': 'OG003'}, {'value': '-78.4', 'spread': '16.60', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 24', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in PASI Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-87.7', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '-69.0', 'spread': '22.63', 'groupId': 'OG001'}, {'value': '-48.8', 'spread': '29.69', 'groupId': 'OG002'}, {'value': '-48.0', 'spread': '14.12', 'groupId': 'OG003'}, {'value': '-80.0', 'spread': '17.88', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 36', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in PASI Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'PBO-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'PBO-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg BID during the active treatment phase (Weeks 16-24.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-82.5', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-52.0', 'spread': '29.70', 'groupId': 'OG001'}, {'value': '-54.3', 'spread': '20.55', 'groupId': 'OG002'}, {'value': '-80.0', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG003'}, {'value': '-85.0', 'spread': '17.80', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 48', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG002', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'timeFrame': 'Week 0 to Week 196', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).', 'reportingStatus': 'POSTED', 'populationDescription': 'The Shift change in sPGA was not defined and analyzed. A response defined as achieving sPGA score 0 or 1 with at least 2 points reduction from baseline was a more meaningful clinical endpoint.'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-71.1', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '-73.9', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '-74.2', 'spread': '18.83', 'groupId': 'OG002'}, {'value': '-44.2', 'spread': '26.79', 'groupId': 'OG003'}, {'value': '-76.7', 'spread': '23.70', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 18', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Placebo participants re-randomized at week 16; End of Period = Last observation carried forward in the period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-64.7', 'spread': '15.95', 'groupId': 'OG000'}, {'value': '-66.2', 'spread': '3.62', 'groupId': 'OG001'}, {'value': '-74.5', 'spread': '15.86', 'groupId': 'OG002'}, {'value': '-24.7', 'spread': '49.99', 'groupId': 'OG003'}, {'value': '-74.5', 'spread': '21.66', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 24', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.1', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '-63.4', 'spread': '25.31', 'groupId': 'OG001'}, {'value': '-58.4', 'spread': '29.80', 'groupId': 'OG002'}, {'value': '-39.1', 'spread': '39.39', 'groupId': 'OG003'}, {'value': '-78.5', 'spread': '21.02', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 36', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-75.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-50.6', 'spread': '18.48', 'groupId': 'OG001'}, {'value': '-72.4', 'spread': '14.95', 'groupId': 'OG002'}, {'value': '-75.0', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG003'}, {'value': '-86.1', 'spread': '18.58', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 48', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-78.6', 'groupId': 'OG000', 'lowerLimit': '-83.3', 'upperLimit': '-42.9'}, {'value': '-73.9', 'groupId': 'OG001', 'lowerLimit': '-75.0', 'upperLimit': '-72.7'}, {'value': '-73.3', 'groupId': 'OG002', 'lowerLimit': '-95.3', 'upperLimit': '-47.3'}, {'value': '-49.2', 'groupId': 'OG003', 'lowerLimit': '-69.4', 'upperLimit': '-9.1'}, {'value': '-86.4', 'groupId': 'OG004', 'lowerLimit': '-100.0', 'upperLimit': '-30.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 to Month 18', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; participants who entered into the LTE period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'OG004', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.5', 'groupId': 'OG000', 'lowerLimit': '-91.7', 'upperLimit': '-50.0'}, {'value': '-66.2', 'groupId': 'OG001', 'lowerLimit': '-68.8', 'upperLimit': '-63.6'}, {'value': '-75.0', 'groupId': 'OG002', 'lowerLimit': '-95.5', 'upperLimit': '-56.3'}, {'value': '-41.5', 'groupId': 'OG003', 'lowerLimit': '-61.1', 'upperLimit': '45.5'}, {'value': '-77.4', 'groupId': 'OG004', 'lowerLimit': '-100.0', 'upperLimit': '-42.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 to Month 24', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; participants who entered into the LTE period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-85.7', 'groupId': 'OG000', 'lowerLimit': '-89.3', 'upperLimit': '-83.3'}, {'value': '-63.4', 'groupId': 'OG001', 'lowerLimit': '-81.3', 'upperLimit': '-45.5'}, {'value': '-60.9', 'groupId': 'OG002', 'lowerLimit': '-95.5', 'upperLimit': '-7.7'}, {'value': '-52.2', 'groupId': 'OG003', 'lowerLimit': '-70.0', 'upperLimit': '18.2'}, {'value': '-81.0', 'groupId': 'OG004', 'lowerLimit': '-100.0', 'upperLimit': '-50.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 to Month 36', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; participants who entered into the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-75.0', 'groupId': 'OG000', 'lowerLimit': '-75.0', 'upperLimit': '-75.0'}, {'value': '-50.6', 'groupId': 'OG001', 'lowerLimit': '-63.6', 'upperLimit': '-37.5'}, {'value': '-73.5', 'groupId': 'OG002', 'lowerLimit': '-86.4', 'upperLimit': '-56.3'}, {'value': '-75.0', 'groupId': 'OG003', 'lowerLimit': '-75.0', 'upperLimit': '-75.0'}, {'value': '-91.9', 'groupId': 'OG004', 'lowerLimit': '-100.0', 'upperLimit': '-60.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 to Month 48', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; participants who entered into the LTE period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5', 'spread': '4.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 18', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Includes participants who entered the long term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '-13.5', 'spread': '16.26', 'groupId': 'OG001'}, {'value': '-5.9', 'spread': '5.70', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '2.36', 'groupId': 'OG003'}, {'value': '-6.8', 'spread': '4.27', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 24', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Includes participants who entered the long term extension study'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.7', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '3.37', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '3.56', 'groupId': 'OG003'}, {'value': '-6.0', 'spread': '6.03', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 36', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Includes participants who entered the long term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.0', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '11.31', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-7.0', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG003'}, {'value': '-10.3', 'spread': '5.13', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 48', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat; Includes participants who entered the long term extension study'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '15.33', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 18', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '8.60', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '14.75', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '9.57', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '8.75', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '11.21', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '7.91', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '10.79', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '3.75', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 36', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension study'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '19.83', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '10.07', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.50', 'groupId': 'OG002'}, {'value': '17.6', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '6.54', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 48', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '11.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 18', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension study'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '7.13', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '8.07', 'groupId': 'OG003'}, {'value': '5.0', 'spread': '6.33', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '9.48', 'groupId': 'OG000'}, {'value': '1.0', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '6.05', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '7.49', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '9.27', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 36', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension period'}, {'type': 'SECONDARY', 'title': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24) and during the extension study (Weeks 24-52).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '16.06', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '10.2', 'spread': 'NA', 'comment': 'Standard Deviation is not available because there was only one participant analyzed.', 'groupId': 'OG003'}, {'value': '9.4', 'spread': '6.10', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 to Month 48', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Includes participants who entered the long-term extension period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '60.0', 'groupId': 'OG004', 'lowerLimit': '26.2', 'upperLimit': '87.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 18', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '44.5'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '12.2', 'upperLimit': '73.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 24', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the extension period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 and month 36', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Apremilast 10mg BID', 'description': 'Participants who were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16) remained on apremilast 10 mg BID during the Active Treatment Phase (Weeks 16-24).'}, {'id': 'OG001', 'title': 'Placebo-Apremilast 20 mg BID', 'description': 'Participants who were initially randomized to placebo PO BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24).'}, {'id': 'OG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'OG003', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'OG004', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '60.2'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '30.0', 'groupId': 'OG004', 'lowerLimit': '6.7', 'upperLimit': '65.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Month 48', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; Participants who entered the long-term extension period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants were initially randomized to identically matching placebo (PBO) tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)'}, {'id': 'FG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 10 mg by mouth (PO) BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'FG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'FG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'FG004', 'title': 'Placebo-Apremilast 20mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 20 mg PO BID and continued dosing with apremilast 20 mg BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}, {'id': 'FG005', 'title': 'Placebo-Apremilast 30 mg BID', 'description': 'Participants who were initially randomized to placebo BID during the Placebo-controlled Phase (Weeks 0-16) were re-randomized at Week 16 to apremilast 30 mg PO BID and continued dosing with apremilast 30 mg PO BID during the active treatment phase (Weeks 16-24). At Week 24 (End of core study and beginning of extension study), participants were given the option to enroll into the extension study (PSOR-005E NCT00953875) and continued on the same apremilast dosage they had received at the end of the core study (Weeks 24-52). Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study.'}], 'periods': [{'title': 'Core: Placebo Controlled Phase Week 0-16', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '87'}, {'groupId': 'FG003', 'numSubjects': '88'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 participants completed placebo controlled phase but elected not to continue', 'groupId': 'FG000', 'numSubjects': '72'}, {'comment': '2 participants completed placebo controlled phase but elected not to continue', 'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'comment': '3 participants completed placebo controlled phase but elected not to continue', 'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Core: Active Treatment Phase Week 16-24', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Placebo participants were re-randomized at Week 16 to receive apremilast 20mg or 30mg PO BID.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '2 participants elected not to continue from previous period', 'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '66'}, {'comment': '3 participants elected not to continue from previous period', 'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Extension: Active Treatment Week 24-52', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '27'}]}, {'type': 'Completed Extension and Continued LTE', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Those dosed APR 10 mg BID in extension study were randomly assigned APR 20 mg or 30 mg BID in LTE', 'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'LTE Period: Week 52 to 6 Years', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Those dosed APR 10 mg BID in extension study were randomly assigned APR 20 mg or 30 mg BID in LTE', 'groupId': 'FG002', 'numSubjects': '16'}, {'comment': 'Those dosed APR 10 mg BID in extension study were randomly assigned APR 20 mg or 30 mg BID in LTE', 'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Completed = Completed Long Term Extension study', 'groupId': 'FG002', 'numSubjects': '4'}, {'comment': 'Completed = Completed Long Term Extension study', 'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study consisted of a 16-week randomized, double-blind, placebo-controlled phase, and a 8-week active treatment phase. At Week 24, subjects may have continued on active treatment by entering a 28-week extension study, total = 52 weeks; At completion of the extension study, subjects may have entered in a long term extension (LTE) for 5 + years.', 'preAssignmentDetails': 'Time gaps between the end of one study phase and start of the next phase precluded the continuation of some of the participants in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '352', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'BG001', 'title': 'Apremilast 10mg BID', 'description': 'Participants were initially randomized to apremilast 10 mg PO BID during the Placebo-controlled Phase (Weeks 0-16).'}, {'id': 'BG002', 'title': 'Apremilast 20mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 20 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes those originally randomized to placebo that were re-randomized at Week 16 to APR 20 mg.'}, {'id': 'BG003', 'title': 'Apremilast 30 mg BID', 'description': 'Participants were initially randomized to apremilast (APR) 30 mg PO BID during the Placebo-controlled Phase (Weeks 0-16). Also includes participants originally randomized to placebo that were re-randomized at Week 16 to APR 30 mg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '13.68', 'groupId': 'BG000'}, {'value': '44.4', 'spread': '13.96', 'groupId': 'BG001'}, {'value': '44.6', 'spread': '12.62', 'groupId': 'BG002'}, {'value': '44.1', 'spread': '14.67', 'groupId': 'BG003'}, {'value': '44.3', 'spread': '13.70', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '327', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian/Pacific Islanders', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'American Indian/Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Plaque Psoriasis', 'classes': [{'categories': [{'measurements': [{'value': '19.61', 'spread': '11.632', 'groupId': 'BG000'}, {'value': '18.01', 'spread': '12.366', 'groupId': 'BG001'}, {'value': '19.51', 'spread': '12.151', 'groupId': 'BG002'}, {'value': '19.18', 'spread': '12.015', 'groupId': 'BG003'}, {'value': '18.99', 'spread': '12.004', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'A diagnosis of chronic plaque psoriasis for ≥ 6 months was required prior to screening. Those with moderate to severe plaque psoriasis must have had a Psoriasis Area Severity Index (PASI) score ≥ 12, (PASI was a measure of psoriatic disease severity taking into account lesion characteristics (erythema, thickness, and scaling) and degree of skin and body surface area involvement (BSA) on defined anatomical regions), BSA ≥ 10. Duration of plaque psoriasis was calculated from the date of diagnosis to the date of informed consent. The dates of diagnosis were not available for some participants', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 352}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'dispFirstSubmitDate': '2013-07-26', 'completionDateStruct': {'date': '2015-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2008-10-14', 'dispFirstSubmitQcDate': '2013-07-26', 'resultsFirstSubmitDate': '2014-10-22', 'studyFirstSubmitQcDate': '2008-10-15', 'dispFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-11-06', 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Core Study: Percentage of Participants With a Static Physician Global Assessment (sPGA) Greater Than 2 at Baseline Who Achieved a Score of 0 or 1 at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 24', 'timeFrame': 'Week 0 and Week 24', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less disease.'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease.'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 3 Years', 'timeFrame': 'Week 0 and month 36', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of 0 or 1 at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'The sPGA was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA was a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling . Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3). A lower sPGA score was associated with less severe disease'}], 'primaryOutcomes': [{'measure': 'Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in Psoriasis Area and Severity Index (PASI) at Week 16', 'timeFrame': 'Week 0 and Week 16', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}], 'secondaryOutcomes': [{'measure': 'Core Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in PASI Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy.The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head,trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in PASI Score at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) From Baseline in the PASI Score at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 24. The improvement in PASI score was used as a measure of efficacy..The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Core Study: Time to Achieve a PASI-100 Response During the Placebo Controlled Phase', 'timeFrame': 'Weeks 0 to 16', 'description': 'For PASI-100 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-100 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.'}, {'measure': 'Core Study: Percent Change From Baseline in PASI Score at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score.'}, {'measure': 'Core Study: Percent Change From Baseline in PASI Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).'}, {'measure': 'Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).'}, {'measure': 'Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Placebo Controlled Phase', 'timeFrame': 'Week 0 to Week 16', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'Core Study: Percent Change From Baseline in the Percent of Affected Body Surface Area (BSA) During the Active Treatment Phase at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'Core Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 16', 'timeFrame': 'Week 0 to Week 16', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Physical Component Summary Score at Week 16', 'timeFrame': 'Week 0 to week 16', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2; Mental Component Summary Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Core Study: Change From Baseline in the Medical Outcome Study Short Form 36-Item Health Survey (SF-36), Version 2 Physical Component Summary Score at Week 24', 'timeFrame': 'Week 0 to Week 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)', 'timeFrame': 'Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast', 'description': 'Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculated using the linear trapezoid rule.'}, {'measure': 'Core Study: Area Under the Plasma Concentration-time Curve (AUC0-8)', 'timeFrame': 'Week 24', 'description': 'Area under the concentration versus time curve from time 0 (pre-dose) to 8 hours, calculate using the linear trapezoid rule.'}, {'measure': 'Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast', 'timeFrame': 'Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast', 'description': 'The maximum observed plasma concentration of apremilast observed at Week 14 (steady-state Cmax)'}, {'measure': 'Core Study: Peak; (Maximum) Plasma Concentration (Cmax) of Apremilast', 'timeFrame': 'Week 24', 'description': 'The maximum observed plasma concentration of apremilast observed at Week 24 (steady-state Cmax)'}, {'measure': 'Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)', 'timeFrame': 'Week 14; Predose, 0.5, 1, 2, 3, 4, and 8 hours after the morning dose of apremilast', 'description': 'Time to achieve maximum plasma concentration (Cmax) observed at Week 14 (Time to achieve steady-state Tmax)'}, {'measure': 'Core Study: Time to Maximum Plasma Concentration of Drug (Tmax)', 'timeFrame': 'Week 24', 'description': 'Time to achieve maximum plasma concentration (tmax) observed at Week 24 (Time to achieve steady-state Tmax)'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 52. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 32 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 40 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 52 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'A participant was classified as having achieved a PASI-100 response if the PASI score was reduced by at least 100% from baseline. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'Extension Study: Time to Achieve PASI-75 During the Extension Study', 'timeFrame': 'Week 0 to Week 52', 'description': 'For PASI-75 responders in the extension study, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-75 was achieved.'}, {'measure': 'Extension Study: Time to Achieve PASI-50 During the Extension Study', 'timeFrame': 'Week 0 to Week 52', 'description': 'For PASI-50 responders in the extension study, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-50 was achieved.'}, {'measure': 'Extension Study: Time to Achieve PASI-90 During the Extension Study', 'timeFrame': 'Week 0 to Extension study', 'description': 'For PASI-90 responders in the extension study, time to achieve PASI-90 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-90 was achieved.'}, {'measure': 'Extension Study: Time to Achieve PASI-100 During the Extension Study', 'timeFrame': 'Week 0 to Extension Study', 'description': 'For PASI-100 responders in the extension study, time to achieve PASI-100 was defined as the time interval, inclusive between the date of randomization (Day 1) and the date of the first assessment where PASI-100 was achieved.'}, {'measure': 'Extension Study: Percent Change in PASI Score at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'Extension Study: Percent Change in PASI Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'Extension Study: Percent Change in PASI Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).'}, {'measure': 'Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).'}, {'measure': 'Extension Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the subject and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).'}, {'measure': 'Extension Study: Percent Change From Baseline in the Affected BSA at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'Extension Study: Percent Change From Baseline in the Affected BSA at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'Extension Study: Percent Change From Baseline in the Affected BSA at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'Extension Study: Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score (PCS) at Week 32', 'timeFrame': 'Week 0 to Week 32', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Extension Study: Change From Baseline in Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 40', 'timeFrame': 'Week 0 to Week 40', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Mental Component Summary Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'Extension Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value..'}, {'measure': 'Extension Study: Dose-response Relationship Using the Percent Reduction of PASI Scores at Week 52', 'timeFrame': 'Week 0 to Week 52', 'description': 'Dose response relationship using percent reduction in PASI scores across dose groups at Week 52 compared to Week 0'}, {'measure': 'Extension Study: Time to Loss of Response During the Treatment Phase of the Extension Study.', 'timeFrame': 'Week 0 to 52', 'description': 'Time to 50% loss of the maximal improvement (achieved in either the core study or the extension study) during the treatment phase of the extension study, in participants who achieved ≥ PASI-50 in either the core study or during the treatment phase of the extension study'}, {'measure': 'Time to Loss of 50% of the PASI Response During the Observational Follow-up Phase Relative to the End of Treatment (Participants Who Had at Least a PASI-50 Response at the End of Treatment Phase)', 'timeFrame': 'Up to 4 weeks after the last dose', 'description': 'Time to loss of response was modified to be 50% loss in the PASI response observed at the end of treatment for participants who achieved at least a PASI-50 at the end of treatment. This definition was changed since participants may have already lost their maximal PASI response prior to enrollment into the Observation Follow-up Phase. Included all participants that enrolled into the observational follow-up phase after the treatment phase.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Placebo Controlled Phase', 'timeFrame': 'Week 0 to Week 16; up to data cut off of 21 July 2011', 'description': "An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose."}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period', 'timeFrame': 'Week 0-88; up to data cut off of 21 July 2011', 'description': "An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose."}, {'measure': 'Core Study: Time to Achieve a PASI-50 Response During the Placebo Controlled Phase', 'timeFrame': 'Week 0 to 16', 'description': 'For PASI-50 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-50 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-50 was achieved.'}, {'measure': 'Core Study: Time to Achieve a PASI-75 Response During the Placebo Controlled Phase', 'timeFrame': 'Weeks 0 to 16', 'description': 'For PASI-75 responders in the placebo-controlled period Weeks 0-16, time to achieve PASI-75 was defined as the time interval, inclusive between the date of randomization (day 1) and the date of the first assessment where PASI-75 is achieved.'}, {'measure': 'Core Study: Time to Achieve a PASI-90 Response During the Placebo Controlled Phase', 'timeFrame': 'Weeks 0 to 16', 'description': 'For PASI-90 responders in the placebo-controlled period weeks 0-16, time to achieve PASI-90 was the time interval, inclusive, between the date of randomization (day 1) and the date of the first assessment where PASI-90 was achieved.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) in the Apremilast Exposure Period', 'timeFrame': 'Week 0 to 6 years of study treatment; maximum duration of exposure was 314.6 weeks', 'description': "An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose."}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 75% Improvement (Response) in the PASI Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 50% Improvement (Response) in the PASI Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 76 of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 100 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 148 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 90% Improvement (Response) in the PASI Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from baseline in PASI score at Week 196 of the extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percentage of Participants Who Achieved a 100% Improvement (Response) in the PASI Score at 18 Months, 2 Years, 3 Years and 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'PASI-100 response is the percentage of participants who achieved at a 100% reduction (improvement) from baseline in PASI score of the long-term extension study. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).'}, {'measure': 'LTE Study: Percent Change From Baseline in PASI Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'LTE Study: Percent Change From Baseline in PASI Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'LTE Study: Percent Change From Baseline in PASI Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'LTE Study: Percent Change From Baseline in PASI Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling were scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions was scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The values for each anatomic region were summed to yield the PASI score'}, {'measure': 'Core Study: Shift Change (1 or More Points on a 0 to 5 Point Scale) in Static Physician Global Assessment (sPGA) at Month 18, and Years 2, 3 and 4', 'timeFrame': 'Week 0 to Week 196', 'description': 'Physician Global Assessment (sPGA) was a measure of psoriasis disease severity at the time of evaluation by the investigator. It does not compare assessments across visits or rely on investigator recall of prior disease severity. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examined all of the lesions on the participant and assigned a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equaled the overall sPGA score. Fractional values for the sPGA were rounded to the next highest integer (eg, a score of 3.5 was rounded to 4, 3.4 was rounded to 3).'}, {'measure': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Percent Change From Baseline in the Percent of the Affected Body Surface Area (BSA) at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Median Percent Change From Baseline in the Affected Body Surface Area (BSA) at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'The overall BSA affected by psoriasis was estimated by comparison of the size of the affected area to the palm area of the participant\'s hand (entire palmar surface or "handprint"), which equates to approximately 1% of total BSA.'}, {'measure': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'LTE Study: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': "The DLQI was a validated, self-administered, 10-item questionnaire that measures the impact of skin disease on subjects' quality of life, based on recall over the past week. Domains include symptoms, feelings, daily activities, social, leisure, work or studying, personal relationships and treatment. Each question on the extent of the impact of skin disease was answered on a scale of 0 (not at all) to 3 (very much); the total DLQI score ranged from 0 to 30. A DLQI score greater than 10 is indicative of severe psoriasis."}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Mental Component Summary Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form,SF-36, Version 2; Physical Component Summary Score at 18 Months', 'timeFrame': 'Week 0 to Month 18', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 2 Years', 'timeFrame': 'Week 0 to Month 24', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 3 Years', 'timeFrame': 'Week 0 to Month 36', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}, {'measure': 'LTE Study: Change From Baseline in the Medical Outcome Study Short Form, SF-36, Version 2; Physical Component Summary Score at 4 Years', 'timeFrame': 'Week 0 to Month 48', 'description': 'The SF-36 was a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Two overall summary scores were obtained - a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS). Scores from the 8 scales, PCS and MCS were transformed to the norm-based scores using weights from U.S. general population, with 50 as the average and 10 as the standard deviation, higher scores indicating better health. For norm based scores, change from baseline were calculated for the 8 scales and the two summary scales, where change = visit value - baseline value.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['moderate-to-severe plaque-type psoriasis'], 'conditions': ['Psoriasis', 'Plaque-type Psoriasis']}, 'referencesModule': {'references': [{'pmid': '22748702', 'type': 'BACKGROUND', 'citation': 'Papp K, Cather JC, Rosoph L, Sofen H, Langley RG, Matheson RT, Hu C, Day RM. Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial. Lancet. 2012 Aug 25;380(9843):738-46. doi: 10.1016/S0140-6736(12)60642-4. Epub 2012 Jun 29.'}, {'pmid': '29905383', 'type': 'BACKGROUND', 'citation': 'Ohtsuki M, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018 Sep;45(9):1053-1062. doi: 10.1111/1346-8138.14504. Epub 2018 Jun 15.'}, {'pmid': '29502473', 'type': 'BACKGROUND', 'citation': 'Knuckles MLF, Levi E, Soung J. Defining and treating moderate plaque psoriasis: a dermatologist survey. J Dermatolog Treat. 2018 Nov;29(7):658-663. doi: 10.1080/09546634.2018.1443200. Epub 2018 Mar 22.'}, {'pmid': '30339049', 'type': 'BACKGROUND', 'citation': 'Knuckles MLF, Levi E, Soung J. Treating moderate plaque psoriasis: prospective 6-month chart review of patients treated with apremilast. J Dermatolog Treat. 2019 Aug;30(5):430-434. doi: 10.1080/09546634.2018.1528326. Epub 2018 Nov 26.'}, {'pmid': '30652520', 'type': 'BACKGROUND', 'citation': 'Wu JJ, Pelletier C, Ung B, Tian M. Real-world treatment patterns and healthcare costs among biologic-naive patients initiating apremilast or biologics for the treatment of psoriasis. J Med Econ. 2019 Apr;22(4):365-371. doi: 10.1080/13696998.2019.1571500. Epub 2019 Feb 4.'}, {'pmid': '30747550', 'type': 'BACKGROUND', 'citation': 'Wang Y, Coyne K, Sofen H, Santanello N, Currie B, Zhang Z, Nograles K. Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp. J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.'}, {'pmid': '23663752', 'type': 'RESULT', 'citation': 'Strand V, Fiorentino D, Hu C, Day RM, Stevens RM, Papp KA. Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomized, controlled study. Health Qual Life Outcomes. 2013 May 10;11:82. doi: 10.1186/1477-7525-11-82.'}, {'pmid': '37316690', 'type': 'DERIVED', 'citation': "Mease PJ, Hatemi G, Paris M, Cheng S, Maes P, Zhang W, Shi R, Flower A, Picard H, Stein Gold L. Apremilast Long-Term Safety Up to 5 Years from 15 Pooled Randomized, Placebo-Controlled Studies of Psoriasis, Psoriatic Arthritis, and Behcet's Syndrome. Am J Clin Dermatol. 2023 Sep;24(5):809-820. doi: 10.1007/s40257-023-00783-7. Epub 2023 Jun 14."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to test if the drug apremilast was safe, if it helped improve psoriasis, and how well the participants tolerated it.', 'detailedDescription': 'This study fully explored the extent of treatment benefit achieved with doses of apremilast up to 30 mg by mouth (PO) twice daily (BID) with treatment duration for up to 6 months. In addition, it was important to determine the minimally effective dose for apremilast and more fully elucidate the dose response curve in this patient population. The results from this study helped guide the selection of the dose in the phase 3 trials.\n\nParticipants meeting eligibility criteria at the Baseline Visit (Week 0) were centrally randomized with the use of a permuted-block randomization list, with equal allocation to each of the four treatment arms: 10 mg, 20 mg or 30 mg PO BID of apremilast or placebo. In an effort to mitigate the dose-dependent adverse effects of apremilast (e.g., headache or gastrointestinal disturbances), participants had their dose titrated over a 7-day period (Days 1 through7). Participants received 10 mg PO BID of apremilast or identically-appearing placebo during Days 1 to 2. Participants randomized to the 10 mg BID dose continued taking this dose throughout the treatment phase of the study. Those participants randomized to the 20 mg BID dose were dose titrated to 20 mg PO BID of apremilast or identically-appearing placebo during Days 3 to 4 of dosing. Participants randomized to the 20 mg BID dose continued taking this dose throughout the treatment phase of the study. Those participants randomized to the 30 mg BID dose were dose titrated to 30 mg PO BID of apremilast or identically-appearing placebo during Days 5 to 7 and continued taking this dose throughout the treatment phase of the study. At Week 16, all participants originally randomized to the placebo arm were re-randomized to 20 mg BID or 30 mg BID of apremilast. All participants (i.e., those that were continuing their Apremilast dosing regimen, as well as those that were switched from placebo to apremilast) received drug at Week 16 in a treatment arm in a blinded fashion. In addition, participants who transitioned from placebo to active medication at Week 16 completed a dose titration schedule to help mitigate any potential GI side effects that may have jeopardized the blinding of the treatment arms.\n\nAt Week 24 (end of core study and beginning of an extension study), participants were given the option to enroll into an extension study (PSOR-005E NCT00953875) and continue on the same apremilast dosage they had received at the end of the core study, during Weeks 24-52, a total of 28 weeks. Participants who elected not to enter into the treatment extension study, completed a 4-week observational follow-up phase of the core study. At Week 52 (end of extension study and beginning of a long-term extension study), participants were given the option to enroll into a long term extension study (PSOR-005LTE NCT01130116), for 4 additional years. Participants who were treated with apremilast 10 mg BID in the extension study were randomly assigned and dose titrated to either apremilast 20 mg BID or 30 mg BID. Participants who were dosed with 20mg or 30 mg BID in the extension study continued to receive the same dose in the long-term extension study. The long-term extension study is anticipated to complete in May 2016.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understand and voluntarily sign an informed consent form\n* ≥18 years of age at the time of signing the informed consent form\n* Able to adhere to the study visit schedule and other protocol requirements.\n* Diagnosis of chronic, stable plaque psoriasis at least 6 months prior to screening as defined by:\n\n 1. PASI (Psoriasis Area and Severity Index) score ≥ 12\n 2. Body Surface Area (BSA) ≥ 10%\n* Candidate for photo/systemic therapy\n* In good health as judged by the investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis\n* Meet all laboratory criteria as defined per protocol\n* Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception methods. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication\n* Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 84 days after taking the last dose of study medication\n\nExclusion Criteria:\n\n* History of clinically significant disease (as determined by the investigator)\n* Pregnant or breastfeeding\n* History of active mycobacterial infection within 3 years\n* History of Human Immunodeficiency Virus (HIV) infection\n* Congenital and acquired immunodeficiencies\n* Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening\n* Antibodies to Hepatitis C at screening\n* Malignancy or history of malignancy except for treated \\[i.e., cured\\] basal-cell skin carcinomas\n* Any condition, including the presence of laboratory abnormalities, that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study\n* Psoriasis flare within 4 weeks of screening\n* Topical therapy within 2 weeks of randomization\n* Systemic therapy for psoriasis within 4 weeks of randomization\n* Use of phototherapy within 4 weeks of randomization \\[(i.e., Ultraviolet (UVB), Psoralens and long-wave ultraviolet radiation (PUVA)\\]\n* Adalimumab, etanercept, efalizumab or infliximab within 12 weeks of randomization\n* Alefacept within 24 weeks of randomization\n* Investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer)\n* Prolonged sun exposure or use of tanning booths or other ultraviolet light sources'}, 'identificationModule': {'nctId': 'NCT00773734', 'briefTitle': 'Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)', 'nctIdAliases': ['NCT00953875', 'NCT01130116'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate-to-Severe Plaque-Type Psoriasis (Core Study)', 'orgStudyIdInfo': {'id': 'CC-10004-PSOR-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apremilast 10mg', 'description': 'Apremilast 10 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 10 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase', 'interventionNames': ['Drug: Apremilast 10mg']}, {'type': 'EXPERIMENTAL', 'label': 'Apremilast 20mg', 'description': 'Apremilast 20 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 20 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase', 'interventionNames': ['Drug: Apremilast 20mg']}, {'type': 'EXPERIMENTAL', 'label': 'Apremilast 30 mg', 'description': 'Apremilast 30 mg administered orally twice daily (BID) for 16 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for 8 weeks in the active treatment phase', 'interventionNames': ['Drug: Apremilast 30 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral Placebo tablets administered twice daily (BID) for 16 weeks during the placebo-controlled phase.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/Apremilast 20 mg', 'description': 'Participants initially randomized to receive placebo twice daily during the 16 week placebo controlled phase are re-randomized to 20 mg apremilast BID during the 8 week active treatment phase', 'interventionNames': ['Drug: Apremilast 20mg']}, {'type': 'EXPERIMENTAL', 'label': 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