Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT01090427
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2010-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland', 'Latvia', 'Netherlands', 'Spain']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'VICE PRESIDENT IMMUNOLOGY', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through Week 60', 'description': 'Adverse events are provided in the tables below for the 110 participants during 2 time periods in the study: during Weeks 0-12 and during Weeks 12-60.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.', 'otherNumAtRisk': 37, 'otherNumAffected': 17, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ustekinumab Half-Standard Dosage (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight \\<= 60kg, 22.5 mg for participants with weight \\> 60 to \\<= 100kg, and 45 mg for participants with weight \\> 100kg.', 'otherNumAtRisk': 37, 'otherNumAffected': 15, 'seriousNumAtRisk': 37, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Ustekinumab Standard Dosage (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight \\<= 60kg, 45 mg for participants with weight \\> 60 to \\<= 100kg, and 90 mg for participants with weight \\> 100kg.', 'otherNumAtRisk': 36, 'otherNumAffected': 13, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo -> Ustekinumab Half-Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\\> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.', 'otherNumAtRisk': 19, 'otherNumAffected': 15, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo -> Ustekinumab Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\\> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.', 'otherNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Ustekinumab Half-Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -\\> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.', 'otherNumAtRisk': 37, 'otherNumAffected': 28, 'seriousNumAtRisk': 37, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Ustekinumab Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -\\> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.', 'otherNumAtRisk': 36, 'otherNumAffected': 23, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Monocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Lip Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Tooth Deposit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Tooth Impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Bacterial Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Body Tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Erythema Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '69.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}, {'value': '80.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=\\>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of the PASI 75 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups", 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '6.43', 'groupId': 'OG001'}, {'value': '-6.7', 'spread': '5.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] will be used as factors in the model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] will be used as factors in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'description': "The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable participants for CDLQI are the subsets of all randomized participants with evaluable outcome measurements.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '54.1', 'groupId': 'OG001'}, {'value': '61.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of the PASI 90 response at Week 12 was performed using the all randomized subjects analysis set defined as the population of all participants who were randomized to any treatment group.'}, {'type': 'SECONDARY', 'title': "The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'title': 'PGA of 0', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}, {'value': '47.2', 'groupId': 'OG002'}]}]}, {'title': 'PGA of 0, 1, or 2', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}, {'value': '81.1', 'groupId': 'OG001'}, {'value': '83.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PGA of 0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'PGA of 0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PGA of 0, 1, or 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'PGA of 0, 1, or 2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'title': 'PASI 50 responders', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '81.1', 'groupId': 'OG001'}, {'value': '88.9', 'groupId': 'OG002'}]}]}, {'title': 'Participants with PASI score of 0', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PASI 50 responders', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'PASI 50 responders', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Participants with PASI score of 0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Participants with PASI score of 0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (\\>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements.'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'title': 'PedsQL Total scale score', 'categories': [{'measurements': [{'value': '3.35', 'spread': '10.044', 'groupId': 'OG000'}, {'value': '10.81', 'spread': '12.882', 'groupId': 'OG001'}, {'value': '8.03', 'spread': '10.436', 'groupId': 'OG002'}]}]}, {'title': 'PedsQL Psychosocial health summary score', 'categories': [{'measurements': [{'value': '3.66', 'spread': '9.610', 'groupId': 'OG000'}, {'value': '12.13', 'spread': '15.153', 'groupId': 'OG001'}, {'value': '8.43', 'spread': '11.812', 'groupId': 'OG002'}]}]}, {'title': 'PedsQL Physical health summary score', 'categories': [{'measurements': [{'value': '2.86', 'spread': '12.860', 'groupId': 'OG000'}, {'value': '8.33', 'spread': '11.378', 'groupId': 'OG001'}, {'value': '7.29', 'spread': '13.446', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PedsQL Total Scale Score', 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] were used as factors in the model.', 'testedNonInferiority': False}, {'pValue': '0.028', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'PedsQL Total Scale Score', 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] were used as factors in the model.', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PedsQL Psychosocial health summary score', 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] were used as factors in the model.', 'testedNonInferiority': False}, {'pValue': '0.063', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'PedsQL Psychosocial health summary score', 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] were used as factors in the model.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'PedsQL Physical health summary score', 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] were used as factors in the model.', 'testedNonInferiority': False}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'PedsQL Physical health summary score', 'statisticalMethod': 'ANOVA on van der Waerden normal Score', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Treatment and baseline weight \\[less than or equal to 60 kg vs greater than 60 kg\\] were used as factors in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements available.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'OG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'OG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '38.7', 'groupId': 'OG001'}, {'value': '56.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable subjects defined as the subset of all randomized participants with evaluable outcome measurements. In addition, this analysis was limited to participants with a CDLQI of 0 or 1 at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.'}, {'id': 'FG001', 'title': 'Ustekinumab Half-Standard Dosage (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight \\<= 60kg, 22.5 mg for participants with weight \\> 60 to \\<= 100kg, and 45 mg for participants with weight \\> 100kg.'}, {'id': 'FG002', 'title': 'Ustekinumab Standard Dosage (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight \\<= 60kg, 45 mg for participants with weight \\> 60 to \\<= 100kg, and 90 mg for participants with weight \\> 100kg.'}, {'id': 'FG003', 'title': 'Placebo -> Ustekinumab Half-Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\\> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.'}, {'id': 'FG004', 'title': 'Placebo -> Ustekinumab Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Placebo at Weeks 0 and 4 -\\> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.'}, {'id': 'FG005', 'title': 'Ustekinumab Half-Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -\\> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.'}, {'id': 'FG006', 'title': 'Ustekinumab Standard Dosage (After CP)', 'description': 'After Controlled period (Week 12-60) - participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -\\> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.'}], 'periods': [{'title': 'Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'comment': '"0" in column indicates this reporting group is not relevant to Control Period.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Control Period.', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Control Period.', 'groupId': 'FG005', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Control Period.', 'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'After Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"0" in column indicates this reporting group is not relevant to after Control Period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to after Control Period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to after Control Period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '37'}, {'groupId': 'FG006', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 110 volunteers from 10 countries were randomized and treated in this study.', 'preAssignmentDetails': 'A total of 110 participants started and completed the first period in the study (ie, controlled period \\[CP\\] and entered the 2nd period (ie, After the Controlled Period \\[after CP\\]); however, only 101 of the 110 participants completed the 2nd period (after CP) of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.'}, {'id': 'BG001', 'title': 'Ustekinumab Half-Standard Dosage', 'description': 'Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'BG002', 'title': 'Ustekinumab Standard Dosage', 'description': 'Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '1.46', 'groupId': 'BG000'}, {'value': '15.1', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '14.8', 'spread': '1.73', 'groupId': 'BG002'}, {'value': '15.2', 'spread': '1.65', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age', 'classes': [{'title': '12-15 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': '16-17 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'dispFirstSubmitDate': '2014-01-24', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-16', 'studyFirstSubmitDate': '2010-03-18', 'dispFirstSubmitQcDate': '2014-01-24', 'resultsFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2010-03-18', 'dispFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-10', 'studyFirstPostDateStruct': {'date': '2010-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12", 'timeFrame': 'Week 12', 'description': "The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 or 1 at Week 12 in each treatment group."}], 'secondaryOutcomes': [{'measure': 'The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12', 'timeFrame': 'Week 12', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. A PASI 75 response is defined as a equal to or greater than (=\\>) 75% improvement in PASI score from baseline. The table below shows the percentage of participants who achieved a PASI 75 response at Week 12 in each treatment group.'}, {'measure': "Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups", 'timeFrame': 'Baseline; Week 12', 'description': "The CDLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a child's quality of life. The CDLQI, a 10-item questionnaire has 4 items response options and a recall period of 1 week. In addition to evaluating overall quality of life, the CDLQI can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, leisure, School or holidays, personal relationships, sleep, and treatment. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in quality of life. The table below shows the mean change in CDLQI score from baseline at Week 12 for each treatment group."}, {'measure': 'The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups', 'timeFrame': 'Week 12', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72, with higher scores indicating worse disease. The table below shows the percentage of participants who achieved a PASI 90 response defined as achieving a greater than or equal to (≥) 90% improvement in PASI score from baseline.'}, {'measure': "The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12", 'timeFrame': 'Week 12', 'description': "The PGA documents the physician's assessment of the participant's psoriasis status according to the following categories: induration, scaling, and erythema. The participant's psoriasis is assessed as 5-point scale as follows: cleared (0), minimal (1), mild (2), moderate (3), or severe (4); higher score indicates worse disease. The table below shows the percentage of participants who achieved a PGA score of 0 and the percentage of participants who achieved a PGA score of 0, 1, or 2 at Week 12 in each treatment group."}, {'measure': 'The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12', 'timeFrame': 'Week 12', 'description': 'The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease). The table below shows the percentage of participants in each treatment group who were PASI 50 responders at Week 12 defined as participants who achieved a greater than or equal to (\\>=) 50% improvement in PASI score from baseline as well as the percentage of participants with a PASI score of 0.'}, {'measure': 'The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12', 'timeFrame': 'Week 12', 'description': 'The PedsQL is a general health-related quality of life measure developed for use in children and adolescent populations. The Generic Core Scale contains 23 items and is comprised of 4 domains: physical, social, emotional, and school functioning. Each domain can be scored independently. Additionally, a Psychosocial Health and Physical Health Summary Score can be calculated as well as a total score. The measure distinguishes between healthy children and children with acute and chronic health conditions and disease severity within a chronic health condition. The measure is applicable for healthy school and community populations, as well as with pediatric populations with acute and chronic health conditions and has versions for both parent and teen report. Scores range from 0 to 100, and higher scores indicate better health related quality of life.'}, {'measure': 'The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1', 'timeFrame': 'Week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ustekinumab', 'Injection', 'CNTO 1275', 'Stelara', 'Pediatric psoriasis', 'Adolescents'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '36171515', 'type': 'DERIVED', 'citation': 'Leu JH, Shiff NJ, Clark M, Bensley K, Lomax KG, Berezny K, Nelson RM, Zhou H, Xu Z. Intravenous Golimumab in Patients with Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis and Subcutaneous Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Extrapolation of Data from Studies in Adults and Adjacent Pediatric Populations. Paediatr Drugs. 2022 Nov;24(6):699-714. doi: 10.1007/s40272-022-00533-y. Epub 2022 Sep 28.'}, {'pmid': '26259989', 'type': 'DERIVED', 'citation': 'Landells I, Marano C, Hsu MC, Li S, Zhu Y, Eichenfield LF, Hoeger PH, Menter A, Paller AS, Taieb A, Philipp S, Szapary P, Randazzo B. Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: results of the randomized phase 3 CADMUS study. J Am Acad Dermatol. 2015 Oct;73(4):594-603. doi: 10.1016/j.jaad.2015.07.002. Epub 2015 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.', 'detailedDescription': "This is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. The total duration of study will be 60 weeks. The study will consists of 2 parts; a Screening period and a Treatment period. In treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or Placebo. Participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at Week 0, will receive placebo at Week 12 and participants receiving placebo at Week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage Weeks 12, 16, 28, and 40. Primarily efficacy will be evaluated by physician's global assessment (PGA) score of cleared or minimal disease. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months\n* Are candidates for phototherapy or systemic treatment of psoriasis\n* Have screening laboratory test results within the study parameters\n\nExclusion Criteria:\n\n* Currently have nonplaque forms of psoriasis\n* Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab\n* Received conventional systemic therapies or phototherapy within the last 4 weeks\n* Received biologic therapies within the last 3 months'}, 'identificationModule': {'nctId': 'NCT01090427', 'briefTitle': 'A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)', 'nctIdAliases': ['NCT02166203'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the of Efficacy and Safety of Ustekinumab in the Treatment of Adolescent Subjects With Moderate to Severe Plaque-type Psoriasis (CADMUS)', 'orgStudyIdInfo': {'id': 'CR017053'}, 'secondaryIdInfos': [{'id': 'CNTO1275PSO3006', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': 'CADMUS', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2009-014368-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ustekinumab Half-standard Dosage', 'description': 'Participants will receive ustekinumab at half the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.', 'interventionNames': ['Drug: Ustekinumab - Half-Standard Dosage', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ustekinumab Standard Dosage', 'description': 'Participants will receive ustekinumab at the standard dosage at Weeks 0, 4, 16, 28, and 40. In addition, all participants will receive a single SC dose of placebo at Week 12.', 'interventionNames': ['Drug: Ustekinumab - Standard Dosage', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants will receive matching placebo at Week 0 and 4, followed by ustekinumab at half-standard or standard dosage at Weeks 12, 16, 28, and 40.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ustekinumab - Half-Standard Dosage', 'type': 'DRUG', 'description': 'Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.', 'armGroupLabels': ['Ustekinumab Half-standard Dosage']}, {'name': 'Ustekinumab - Standard Dosage', 'type': 'DRUG', 'description': 'Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.', 'armGroupLabels': ['Ustekinumab Standard Dosage']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.', 'armGroupLabels': ['Placebo', 'Ustekinumab Half-standard Dosage', 'Ustekinumab Standard Dosage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'city': "St. John's", 'state': 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'lon': -1.08271}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}