Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-04-27 @ 4:20 PM
Study NCT ID:
NCT00650767
Status:
COMPLETED
Last Update Posted:
2020-12-01
First Post:
2008-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@arraybiopharma.com', 'phone': '303-381-6604', 'title': 'Study Director', 'organization': 'Array BioPharma, Inc.'}, 'certainAgreement': {'otherDetails': "The terms and conditions of the sponsor's agreements with its investigators may vary. However, the sponsor does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Emergent Adverse Events (TEAEs) were collected for approximately 1 year. They were collected throughout the duration of the study, which began in April, 2008 and concluded in July, 2009. All patients who were enrolled in the study and received at least one dose of study drug were included in AE reporting.', 'description': 'An AE is any untoward medical occurrence including the exacerbation of a pre-existing condition, in a patient or clinical investigation subject administered a pharmaceutical product. This does not necessarily have a causal relationship with this treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.', 'otherNumAtRisk': 49, 'otherNumAffected': 20, 'seriousNumAtRisk': 49, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.', 'otherNumAtRisk': 49, 'otherNumAffected': 25, 'seriousNumAtRisk': 49, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.', 'otherNumAtRisk': 50, 'otherNumAffected': 39, 'seriousNumAtRisk': 50, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.', 'otherNumAtRisk': 50, 'otherNumAffected': 42, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GASTRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'APHTHOUS STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ENTEROCOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ANAL FISSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CHEILITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EROSIVE OESOPHAGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'FOOD POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GASTRITIS EROSIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'IRRITABLE BOWEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'TONGUE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HAEMORRHOIDAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HIATUS HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DERMATITIS ACNEIFORM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ACNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ROSACEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RASH ERYTHEMATOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RASH PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ECCHYMOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'LIVEDO RETICULARIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ONYCHOCLASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'PERIORBITAL OEDEMA', 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'OG000', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '14.3'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '10.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '14.3'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '10.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '14.0'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '14.3'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '14.0'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '13.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '19.6'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '25.2'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '19.6'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '16.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '16.9'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '17.2'}, {'value': '6.1', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '16.9'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '21.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '5.49', 'groupId': 'OG001'}, {'value': '15.0', 'spread': '5.98', 'groupId': 'OG002'}, {'value': '17.0', 'spread': '5.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '6.24', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '6.46', 'groupId': 'OG002'}, {'value': '11.1', 'spread': '5.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '6.49', 'groupId': 'OG001'}, {'value': '11.4', 'spread': '6.31', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '6.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '6.31', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '6.84', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '6.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '7.21', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '7.04', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '6.27', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '5.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '7.05', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '7.50', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '6.57', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '7.13', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '7.15', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '7.37', 'groupId': 'OG002'}, {'value': '8.9', 'spread': '6.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '4.10', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '4.96', 'groupId': 'OG002'}, {'value': '13.0', 'spread': '5.31', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '4.65', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '4.80', 'groupId': 'OG002'}, {'value': '9.1', 'spread': '4.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '5.45', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '4.98', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '4.58', 'groupId': 'OG002'}, {'value': '7.3', 'spread': '5.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '4.70', 'groupId': 'OG002'}, {'value': '7.1', 'spread': '6.03', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '5.25', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.64', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '5.51', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '5.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '5.67', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '4.86', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '5.54', 'groupId': 'OG002'}, {'value': '6.3', 'spread': '5.92', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '4.63', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '5.72', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '5.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '18.94', 'groupId': 'OG000'}, {'value': '61.9', 'spread': '20.32', 'groupId': 'OG001'}, {'value': '62.4', 'spread': '21.42', 'groupId': 'OG002'}, {'value': '63.0', 'spread': '18.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '25.16', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '22.94', 'groupId': 'OG001'}, {'value': '48.4', 'spread': '22.53', 'groupId': 'OG002'}, {'value': '42.6', 'spread': '20.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '23.89', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '22.61', 'groupId': 'OG001'}, {'value': '47.7', 'spread': '25.20', 'groupId': 'OG002'}, {'value': '39.6', 'spread': '22.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '23.78', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '25.23', 'groupId': 'OG001'}, {'value': '44.8', 'spread': '24.48', 'groupId': 'OG002'}, {'value': '39.0', 'spread': '19.75', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'spread': '26.53', 'groupId': 'OG000'}, {'value': '46.1', 'spread': '24.97', 'groupId': 'OG001'}, {'value': '46.4', 'spread': '25.42', 'groupId': 'OG002'}, {'value': '41.5', 'spread': '23.39', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '28.15', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '27.39', 'groupId': 'OG001'}, {'value': '43.8', 'spread': '26.93', 'groupId': 'OG002'}, {'value': '42.3', 'spread': '21.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '27.93', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '26.32', 'groupId': 'OG001'}, {'value': '48.7', 'spread': '27.09', 'groupId': 'OG002'}, {'value': '48.5', 'spread': '23.93', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '20.59', 'groupId': 'OG000'}, {'value': '60.1', 'spread': '20.80', 'groupId': 'OG001'}, {'value': '63.4', 'spread': '19.25', 'groupId': 'OG002'}, {'value': '55.4', 'spread': '20.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.2', 'spread': '24.52', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '22.65', 'groupId': 'OG001'}, {'value': '48.3', 'spread': '22.82', 'groupId': 'OG002'}, {'value': '42.3', 'spread': '20.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '21.74', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '23.62', 'groupId': 'OG001'}, {'value': '49.4', 'spread': '22.61', 'groupId': 'OG002'}, {'value': '40.3', 'spread': '22.33', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'spread': '23.96', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '24.57', 'groupId': 'OG001'}, {'value': '46.7', 'spread': '23.70', 'groupId': 'OG002'}, {'value': '40.0', 'spread': '20.55', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '26.34', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '24.69', 'groupId': 'OG001'}, {'value': '45.5', 'spread': '22.95', 'groupId': 'OG002'}, {'value': '41.8', 'spread': '21.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '26.71', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '23.24', 'groupId': 'OG001'}, {'value': '43.4', 'spread': '24.82', 'groupId': 'OG002'}, {'value': '41.1', 'spread': '19.75', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.9', 'spread': '26.69', 'groupId': 'OG000'}, {'value': '42.6', 'spread': '22.99', 'groupId': 'OG001'}, {'value': '47.5', 'spread': '27.18', 'groupId': 'OG002'}, {'value': '44.8', 'spread': '21.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '16.71', 'groupId': 'OG000'}, {'value': '66.0', 'spread': '13.80', 'groupId': 'OG001'}, {'value': '61.0', 'spread': '15.23', 'groupId': 'OG002'}, {'value': '59.7', 'spread': '13.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '17.80', 'groupId': 'OG000'}, {'value': '47.7', 'spread': '19.55', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '18.21', 'groupId': 'OG002'}, {'value': '41.1', 'spread': '17.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.9', 'spread': '18.61', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '18.67', 'groupId': 'OG001'}, {'value': '43.9', 'spread': '19.45', 'groupId': 'OG002'}, {'value': '35.3', 'spread': '18.27', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '19.83', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '21.55', 'groupId': 'OG001'}, {'value': '38.8', 'spread': '18.40', 'groupId': 'OG002'}, {'value': '34.7', 'spread': '19.20', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '20.96', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '21.21', 'groupId': 'OG001'}, {'value': '36.8', 'spread': '18.88', 'groupId': 'OG002'}, {'value': '32.7', 'spread': '22.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '21.96', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '22.19', 'groupId': 'OG001'}, {'value': '35.7', 'spread': '21.06', 'groupId': 'OG002'}, {'value': '31.2', 'spread': '21.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '20.86', 'groupId': 'OG000'}, {'value': '33.2', 'spread': '19.22', 'groupId': 'OG001'}, {'value': '40.7', 'spread': '21.92', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '20.37', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.65', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '0.68', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '0.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.86', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '1.95', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.85', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '2.17', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '2.36', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '2.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '3.18', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '3.02', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '2.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '2.39', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '3.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.87', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '2.51', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '2.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP) at Week 16 (Follow-up)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '3.33', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.68', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '2.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '6.1', 'spread': '0.77', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '0.97', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '1.14', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '1.19', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '1.24', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '1.40', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '1.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '1.42', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '31.4', 'spread': '7.78', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '8.29', 'groupId': 'OG002'}, {'value': '33.8', 'spread': '9.58', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'spread': '9.05', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '9.10', 'groupId': 'OG001'}, {'value': '34.3', 'spread': '9.73', 'groupId': 'OG002'}, {'value': '38.7', 'spread': '8.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '9.86', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '9.25', 'groupId': 'OG001'}, {'value': '34.9', 'spread': '10.32', 'groupId': 'OG002'}, {'value': '38.2', 'spread': '10.36', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '11.08', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '9.83', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '10.91', 'groupId': 'OG002'}, {'value': '38.8', 'spread': '9.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '9.75', 'groupId': 'OG001'}, {'value': '35.5', 'spread': '8.99', 'groupId': 'OG002'}, {'value': '37.8', 'spread': '9.84', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '8.47', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '8.07', 'groupId': 'OG001'}, {'value': '32.3', 'spread': '7.68', 'groupId': 'OG002'}, {'value': '32.9', 'spread': '8.49', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '8.20', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '9.69', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '7.89', 'groupId': 'OG002'}, {'value': '38.6', 'spread': '7.88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '9.70', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '8.09', 'groupId': 'OG002'}, {'value': '39.2', 'spread': '9.20', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.1', 'spread': '9.65', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '10.36', 'groupId': 'OG001'}, {'value': '37.9', 'spread': '9.46', 'groupId': 'OG002'}, {'value': '39.3', 'spread': '8.12', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '8.50', 'groupId': 'OG001'}, {'value': '36.9', 'spread': '9.48', 'groupId': 'OG002'}, {'value': '38.7', 'spread': '9.21', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '6.22', 'groupId': 'OG001'}, {'value': '32.4', 'spread': '7.18', 'groupId': 'OG002'}, {'value': '33.0', 'spread': '6.50', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '9.22', 'groupId': 'OG001'}, {'value': '38.0', 'spread': '8.58', 'groupId': 'OG002'}, {'value': '41.0', 'spread': '9.22', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '9.05', 'groupId': 'OG000'}, {'value': '39.1', 'spread': '9.73', 'groupId': 'OG001'}, {'value': '38.7', 'spread': '8.27', 'groupId': 'OG002'}, {'value': '40.8', 'spread': '10.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '9.21', 'groupId': 'OG001'}, {'value': '38.7', 'spread': '9.61', 'groupId': 'OG002'}, {'value': '40.9', 'spread': '9.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '10.62', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '9.89', 'groupId': 'OG001'}, {'value': '37.0', 'spread': '9.73', 'groupId': 'OG002'}, {'value': '38.1', 'spread': '9.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '33.6', 'spread': '8.05', 'groupId': 'OG001'}, {'value': '34.0', 'spread': '7.85', 'groupId': 'OG002'}, {'value': '36.1', 'spread': '7.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '9.10', 'groupId': 'OG001'}, {'value': '36.9', 'spread': '9.11', 'groupId': 'OG002'}, {'value': '38.9', 'spread': '9.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '7.96', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '9.10', 'groupId': 'OG001'}, {'value': '36.9', 'spread': '8.21', 'groupId': 'OG002'}, {'value': '39.7', 'spread': '9.29', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '9.13', 'groupId': 'OG001'}, {'value': '36.7', 'spread': '9.28', 'groupId': 'OG002'}, {'value': '39.2', 'spread': '8.74', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '8.60', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '9.02', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '8.53', 'groupId': 'OG002'}, {'value': '38.3', 'spread': '9.25', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '10.10', 'groupId': 'OG000'}, {'value': '41.5', 'spread': '7.79', 'groupId': 'OG001'}, {'value': '41.3', 'spread': '9.17', 'groupId': 'OG002'}, {'value': '44.5', 'spread': '8.30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '10.31', 'groupId': 'OG001'}, {'value': '44.7', 'spread': '9.16', 'groupId': 'OG002'}, {'value': '47.3', 'spread': '9.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '9.76', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '11.08', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '10.03', 'groupId': 'OG002'}, {'value': '49.0', 'spread': '9.30', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '10.20', 'groupId': 'OG001'}, {'value': '46.3', 'spread': '10.56', 'groupId': 'OG002'}, {'value': '47.5', 'spread': '9.41', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.1', 'spread': '10.55', 'groupId': 'OG000'}, {'value': '47.4', 'spread': '11.67', 'groupId': 'OG001'}, {'value': '44.4', 'spread': '9.91', 'groupId': 'OG002'}, {'value': '46.9', 'spread': '9.93', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '10.97', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '9.28', 'groupId': 'OG001'}, {'value': '34.7', 'spread': '9.50', 'groupId': 'OG002'}, {'value': '36.7', 'spread': '10.62', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '9.74', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '10.07', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '10.04', 'groupId': 'OG002'}, {'value': '38.9', 'spread': '9.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '40.0', 'spread': '9.60', 'groupId': 'OG001'}, {'value': '39.0', 'spread': '10.09', 'groupId': 'OG002'}, {'value': '40.2', 'spread': '9.44', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '10.93', 'groupId': 'OG000'}, {'value': '38.9', 'spread': '10.01', 'groupId': 'OG001'}, {'value': '40.2', 'spread': '10.15', 'groupId': 'OG002'}, {'value': '39.6', 'spread': '8.67', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '39.0', 'spread': '10.77', 'groupId': 'OG001'}, {'value': '37.2', 'spread': '10.18', 'groupId': 'OG002'}, {'value': '38.8', 'spread': '10.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '12.17', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '11.66', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '9.96', 'groupId': 'OG002'}, {'value': '32.7', 'spread': '13.03', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.8', 'spread': '10.88', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '12.69', 'groupId': 'OG001'}, {'value': '34.1', 'spread': '10.32', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '10.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '12.19', 'groupId': 'OG000'}, {'value': '38.3', 'spread': '11.79', 'groupId': 'OG001'}, {'value': '34.5', 'spread': '11.09', 'groupId': 'OG002'}, {'value': '36.5', 'spread': '10.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '12.14', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '12.38', 'groupId': 'OG001'}, {'value': '35.0', 'spread': '11.46', 'groupId': 'OG002'}, {'value': '36.5', 'spread': '11.17', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.4', 'spread': '13.11', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '10.77', 'groupId': 'OG001'}, {'value': '35.2', 'spread': '10.73', 'groupId': 'OG002'}, {'value': '36.1', 'spread': '12.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '10.99', 'groupId': 'OG001'}, {'value': '36.1', 'spread': '11.39', 'groupId': 'OG002'}, {'value': '38.9', 'spread': '12.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '12.95', 'groupId': 'OG001'}, {'value': '38.9', 'spread': '12.64', 'groupId': 'OG002'}, {'value': '40.9', 'spread': '10.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '11.70', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '12.44', 'groupId': 'OG001'}, {'value': '39.7', 'spread': '12.63', 'groupId': 'OG002'}, {'value': '42.7', 'spread': '11.43', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.0', 'spread': '11.23', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '11.58', 'groupId': 'OG001'}, {'value': '39.7', 'spread': '12.14', 'groupId': 'OG002'}, {'value': '41.7', 'spread': '11.66', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '12.27', 'groupId': 'OG000'}, {'value': '41.4', 'spread': '13.00', 'groupId': 'OG001'}, {'value': '37.7', 'spread': '11.70', 'groupId': 'OG002'}, {'value': '40.4', 'spread': '12.11', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '12.47', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '10.91', 'groupId': 'OG001'}, {'value': '37.3', 'spread': '10.11', 'groupId': 'OG002'}, {'value': '40.0', 'spread': '11.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '11.01', 'groupId': 'OG000'}, {'value': '43.3', 'spread': '12.95', 'groupId': 'OG001'}, {'value': '39.9', 'spread': '11.52', 'groupId': 'OG002'}, {'value': '40.4', 'spread': '10.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '43.7', 'spread': '11.41', 'groupId': 'OG001'}, {'value': '40.6', 'spread': '12.35', 'groupId': 'OG002'}, {'value': '42.8', 'spread': '10.82', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'spread': '11.06', 'groupId': 'OG000'}, {'value': '43.1', 'spread': '11.31', 'groupId': 'OG001'}, {'value': '40.9', 'spread': '11.66', 'groupId': 'OG002'}, {'value': '41.7', 'spread': '11.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.4', 'spread': '11.98', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '12.10', 'groupId': 'OG001'}, {'value': '39.3', 'spread': '11.14', 'groupId': 'OG002'}, {'value': '41.1', 'spread': '11.92', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'spread': '6.06', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '5.91', 'groupId': 'OG001'}, {'value': '32.9', 'spread': '6.30', 'groupId': 'OG002'}, {'value': '33.9', 'spread': '6.98', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '7.47', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '7.73', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '7.08', 'groupId': 'OG002'}, {'value': '40.5', 'spread': '7.57', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '8.12', 'groupId': 'OG001'}, {'value': '37.2', 'spread': '6.73', 'groupId': 'OG002'}, {'value': '40.0', 'spread': '8.78', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '8.26', 'groupId': 'OG000'}, {'value': '38.3', 'spread': '8.82', 'groupId': 'OG001'}, {'value': '38.2', 'spread': '8.65', 'groupId': 'OG002'}, {'value': '40.3', 'spread': '8.16', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'OG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '9.50', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '7.34', 'groupId': 'OG001'}, {'value': '37.2', 'spread': '7.95', 'groupId': 'OG002'}, {'value': '39.0', 'spread': '7.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis group is comprised of the Efficacy Evaluable population, which is all randomized patients who had at least one post-Baseline assessment of at least one efficacy endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'FG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'FG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'FG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The ARRAY-162-201 study began recruitment on 04-April-2008 (First Patient First Visit) and concluded on 07-July-2009 (Last Patient Last Visit).\n\nThis study was conducted at 36 sites in the United States, Europe and South America.', 'preAssignmentDetails': 'Participant Flow and Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '201', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablets were identical in appearance to both the 10 mg and 20 mg ARRY-438162 tablets.\n\nPatients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'BG001', 'title': 'ARRY-438162: 10 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'BG002', 'title': 'ARRY-438162: 40 mg qd', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'BG003', 'title': 'ARRY-438162: 20 mg Bid', 'description': 'Patients were randomized in a 1:1:1:1 fashion to ARRY-438162 10 mg bid, 40 mg qd or 20 mg bid, or placebo.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'spread': '12.67', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '11.98', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '11.88', 'groupId': 'BG002'}, {'value': '51.4', 'spread': '11.74', 'groupId': 'BG003'}, {'value': '52.6', 'spread': '11.89', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '172', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic Or Latino', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic Or Latino', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '74.1', 'spread': '18.26', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '14.17', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '17.95', 'groupId': 'BG002'}, {'value': '67.2', 'spread': '13.86', 'groupId': 'BG003'}, {'value': '69.2', 'spread': '15.49', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '160.2', 'spread': '8.63', 'groupId': 'BG000'}, {'value': '159.5', 'spread': '8.11', 'groupId': 'BG001'}, {'value': '158.6', 'spread': '9.22', 'groupId': 'BG002'}, {'value': '158.0', 'spread': '7.44', 'groupId': 'BG003'}, {'value': '158.7', 'spread': '8.25', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking Status', 'classes': [{'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}, {'title': 'Never Smoked', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}]}, {'title': 'Past Smoker', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline Demographics represent the Intent-to-Treat (ITT) population, which is all patients who were randomized to a treatment group.'}}, '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': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2009-12-09', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-15', 'studyFirstSubmitDate': '2008-03-31', 'dispFirstSubmitQcDate': '2009-12-09', 'resultsFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2008-03-31', 'dispFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-20', 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American College of Rheumatology 20% (ACR20) Response Rate at Week 12', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.'}], 'secondaryOutcomes': [{'measure': 'American College of Rheumatology 20% (ACR20) Response Rate at Week 1', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 20% (ACR20) Response Rate at Week 2', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 20% (ACR20) Response Rate at Week 4', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 20% (ACR20) Response Rate at Week 8', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 50% (ACR50) Response Rate at Week 1', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 50% (ACR50) Response Rate at Week 2', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 50% (ACR50) Response Rate at Week 4', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 50% (ACR50) Response Rate at Week 8', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 50% (ACR50) Response Rate at Week 12', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 1', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 2', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 4', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 8', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 12', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Baseline', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nTender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Baseline', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Week 1', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Week 2', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Week 4', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Week 8', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Week 12', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': 'American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.\n\nThe swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.'}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Baseline', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Week 1', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Week 2', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Week 4', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Week 8', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Week 12', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)", 'timeFrame': 'Week 16 (Follow-up)', 'description': "The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain."}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Baseline', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 1', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 2', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 4', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 8', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 12', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The Patient\'s Global Assessment of Arthritis was an evaluation based on the patient\'s disease signs, functional capacity and physical examination, and was independent of the Physician\'s Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).\n\nPatients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient\'s response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).'}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Baseline', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 1', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 2', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 4', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 8', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 12', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': "Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)", 'timeFrame': 'Week 16 (Follow-up)', 'description': "The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).\n\nThe physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad)."}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Baseline', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Week 1', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Week 2', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Week 4', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Week 8', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Week 12', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'Health Assessment Questionnaire - Disability Index (HAQ-DI)', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.\n\nThe HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.'}, {'measure': 'C-Reactive Protein (CRP) at Baseline', 'timeFrame': 'Baseline'}, {'measure': 'C-Reactive Protein (CRP) at Week 1', 'timeFrame': 'Week 1'}, {'measure': 'C-Reactive Protein (CRP) at Week 2', 'timeFrame': 'Week 2'}, {'measure': 'C-Reactive Protein (CRP) at Week 4', 'timeFrame': 'Week 4'}, {'measure': 'C-Reactive Protein (CRP) at Week 8', 'timeFrame': 'Week 8'}, {'measure': 'C-Reactive Protein (CRP) at Week 12', 'timeFrame': 'Week 12'}, {'measure': 'C-Reactive Protein (CRP) at Week 16 (Follow-up)', 'timeFrame': 'Week 16 (Follow-up)'}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Baseline', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Week 1', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Week 2', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Week 4', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Week 8', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Week 12', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])', 'timeFrame': 'Week 16 (Follow-up)', 'description': "The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity."}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.\n\nThe SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'timeFrame': 'Baseline', 'description': 'SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'timeFrame': 'Baseline', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'timeFrame': 'Week 4', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'timeFrame': 'Week 8', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'timeFrame': 'Week 12', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}, {'measure': 'SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score', 'timeFrame': 'Week 16 (Follow-up)', 'description': 'The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.\n* Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.\n* Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.\n* No prior use of biological agents for the treatment of rheumatoid arthritis.\n* Additional criteria exist.\n\nKey Exclusion Criteria:\n\n* Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.\n* A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.\n* Additional criteria exist.'}, 'identificationModule': {'nctId': 'NCT00650767', 'briefTitle': 'A Study of ARRY-438162 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Array BioPharma'}, 'orgStudyIdInfo': {'id': 'ARRAY-162-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARRY-438162 (Schedule 1)', 'interventionNames': ['Drug: ARRY-438162, MEK inhibitor; oral']}, {'type': 'EXPERIMENTAL', 'label': 'ARRY-438162 (Schedule 2)', 'interventionNames': ['Drug: ARRY-438162, MEK inhibitor; oral']}, {'type': 'EXPERIMENTAL', 'label': 'ARRY-438162 (Schedule 3)', 'interventionNames': ['Drug: ARRY-438162, MEK inhibitor; oral']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo; oral']}], 'interventions': [{'name': 'ARRY-438162, MEK inhibitor; oral', 'type': 'DRUG', 'description': 'multiple dose, single schedule', 'armGroupLabels': ['ARRY-438162 (Schedule 1)', 'ARRY-438162 (Schedule 2)', 'ARRY-438162 (Schedule 3)']}, {'name': 'Placebo; oral', 'type': 'DRUG', 'description': 'matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Medical Research', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Asistencia Integral en Reumatologia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'CEMIC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Britanico', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'San Juan', 'country': 'Argentina', 'facility': 'CER San Juan', 'geoPoint': {'lat': -31.53726, 'lon': -68.52568}}, {'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro Medico Privado de Reumatologia', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Centro de Investigaciones Clinicas del Litoral SRL', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '74110-120', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'facility': 'Médicos Unidos Ltda.', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '80060', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'CETI - 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