Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-04-10 @ 4:12 AM
Study NCT ID:
NCT02222493
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2014-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'France']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630865', 'term': 'GP1111'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Period 1: Baseline (Day 1) up to Week 30, Period 2: Baseline (Week 30 pre-dose) up to Week 54, Period 3: Baseline (Week 54 pre-dose) up to Week 78', 'description': 'Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or 1 participant may have experienced both a serious and non serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.', 'otherNumAtRisk': 323, 'otherNumAffected': 38, 'seriousNumAtRisk': 323, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.', 'otherNumAtRisk': 326, 'otherNumAffected': 35, 'seriousNumAtRisk': 326, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.', 'otherNumAtRisk': 280, 'otherNumAffected': 8, 'seriousNumAtRisk': 280, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.', 'otherNumAtRisk': 143, 'otherNumAffected': 11, 'seriousNumAtRisk': 143, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.', 'otherNumAtRisk': 143, 'otherNumAffected': 6, 'seriousNumAtRisk': 143, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.', 'otherNumAtRisk': 253, 'otherNumAffected': 0, 'seriousNumAtRisk': 253, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.', 'otherNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.', 'otherNumAtRisk': 126, 'otherNumAffected': 0, 'seriousNumAtRisk': 126, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Multi-organ disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Purulent synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cartilage injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venous stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Ocular lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Genital prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Bone abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 280, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 253, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0; 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.39', 'ciLowerLimit': '-9.92', 'ciUpperLimit': '5.11', 'groupDescription': 'Score statistic method', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalence test'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Proportion Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.39', 'ciLowerLimit': '-8.75', 'ciUpperLimit': '4.02', 'groupDescription': 'Score statistic method', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Equivalence test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': 'ACR20 response: greater than or equal to (\\>=) 20 percent (%) improvement in tender joint count (TJC); \\>= 20% improvement in swollen joint count (SJC); and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index \\[HAQ-DI\\]); and C-Reactive Protein (CRP).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '187', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}, {'title': 'week 22', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}, {'title': 'Week 30 (pre-dose)', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 6, 12, 22 and 30 (pre-dose)', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'Week 38', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}]}, {'title': 'Week 46', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 (pre-dose)', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 38, 46 and 54 (pre-dose)', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'Week 62', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}]}, {'title': 'Week 70', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Week 78', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 62, 70 and 78', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'ACR50 (Week 2)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 (Week 4)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 (Week 6)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 (Week 12)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 (Week 14)', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 (Week 22)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 (Week 30, pre-dose)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 2)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 4)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 6)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 12)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 14)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 22)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 (Week 30, pre-dose)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)', 'description': 'ACR50 response: \\>=50% improvement in tender joint count, \\>=50% improvement in swollen joint count improvement and \\>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \\>=70% improvement in tender joint count, \\>=70% improvement in swollen joint count improvement and \\>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'ACR50 (Week 38)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'ACR50 (Week 46)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'ACR50 (Week 54, pre-dose)', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 (Week 38)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 (Week 46)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 (Week 54, pre-dose)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 38, 46 and 54 (pre-dose)', 'description': 'ACR50 response: \\>=50% improvement in tender joint count, \\>=50% improvement in swollen joint count improvement and \\>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \\>=70% improvement in tender joint count, \\>=70% improvement in swollen joint count improvement and \\>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'ACR50 (Week 62)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'ACR50 (Week 70)', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'ACR50 (Week 78)', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 (Week 62)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 (Week 70)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'ACR70 (Week 78)', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 62, 70 and 78', 'description': 'ACR50 response: \\>=50% improvement in tender joint count, \\>=50% improvement in swollen joint count improvement and \\>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \\>=70% improvement in tender joint count, \\>=70% improvement in swollen joint count improvement and \\>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'DAS28-CRP (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.950', 'spread': '0.9577', 'groupId': 'OG000'}, {'value': '5.983', 'spread': '0.9210', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.213', 'spread': '0.9280', 'groupId': 'OG000'}, {'value': '-1.241', 'spread': '0.8879', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.596', 'spread': '1.1259', 'groupId': 'OG000'}, {'value': '-1.605', 'spread': '1.0881', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.710', 'spread': '1.1959', 'groupId': 'OG000'}, {'value': '-1.750', 'spread': '1.0885', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.898', 'spread': '1.3516', 'groupId': 'OG000'}, {'value': '-1.885', 'spread': '1.2142', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.901', 'spread': '1.4125', 'groupId': 'OG000'}, {'value': '-1.827', 'spread': '1.3019', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.005', 'spread': '1.4236', 'groupId': 'OG000'}, {'value': '-2.002', 'spread': '1.2972', 'groupId': 'OG001'}]}]}, {'title': 'DAS28-CRP (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.140', 'spread': '1.4197', 'groupId': 'OG000'}, {'value': '-2.117', 'spread': '1.2738', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.623', 'spread': '0.6485', 'groupId': 'OG000'}, {'value': '1.586', 'spread': '0.6490', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.317', 'spread': '0.4100', 'groupId': 'OG000'}, {'value': '-0.328', 'spread': '0.4370', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.472', 'spread': '0.4728', 'groupId': 'OG000'}, {'value': '-0.477', 'spread': '0.4861', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.496', 'spread': '0.5505', 'groupId': 'OG000'}, {'value': '-0.520', 'spread': '0.5022', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.535', 'spread': '0.5795', 'groupId': 'OG000'}, {'value': '-0.524', 'spread': '0.5857', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.572', 'spread': '0.5910', 'groupId': 'OG000'}, {'value': '-0.531', 'spread': '0.5876', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.588', 'spread': '0.6061', 'groupId': 'OG000'}, {'value': '-0.569', 'spread': '0.5958', 'groupId': 'OG001'}]}]}, {'title': 'HAQ-DI (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.621', 'spread': '0.6484', 'groupId': 'OG000'}, {'value': '-0.612', 'spread': '0.6546', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30', 'description': 'DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale \\[VAS\\] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (\\<)2.6=remission, \\<3.2=low disease activity, \\>=3.2-5.1=moderate disease activity and greater than (\\>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'DAS28-CRP (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.765', 'spread': '1.4629', 'groupId': 'OG000'}, {'value': '3.819', 'spread': '1.3624', 'groupId': 'OG001'}, {'value': '3.781', 'spread': '1.2547', 'groupId': 'OG002'}]}]}, {'title': 'DAS28-CRP (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.181', 'spread': '0.9574', 'groupId': 'OG000'}, {'value': '0.036', 'spread': '0.8686', 'groupId': 'OG001'}, {'value': '-0.059', 'spread': '0.8756', 'groupId': 'OG002'}]}]}, {'title': 'DAS28-CRP (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.228', 'spread': '1.0453', 'groupId': 'OG000'}, {'value': '0.048', 'spread': '1.2584', 'groupId': 'OG001'}, {'value': '-0.017', 'spread': '1.0692', 'groupId': 'OG002'}]}]}, {'title': 'DAS28-CRP (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.275', 'spread': '1.1338', 'groupId': 'OG000'}, {'value': '-0.109', 'spread': '1.1801', 'groupId': 'OG001'}, {'value': '-0.057', 'spread': '1.2339', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.978', 'spread': '0.7042', 'groupId': 'OG000'}, {'value': '0.913', 'spread': '0.6634', 'groupId': 'OG001'}, {'value': '0.951', 'spread': '0.6481', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.019', 'spread': '0.3328', 'groupId': 'OG000'}, {'value': '0.019', 'spread': '0.2889', 'groupId': 'OG001'}, {'value': '0.007', 'spread': '0.3688', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.043', 'spread': '0.3774', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.3823', 'groupId': 'OG001'}, {'value': '0.035', 'spread': '0.4325', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.4407', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.4399', 'groupId': 'OG001'}, {'value': '-0.044', 'spread': '0.3881', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and 54', 'description': 'DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter \\[mm\\]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \\<2.6=remission, \\<3.2=low disease activity, \\>=3.2-5.1=moderate disease activity and \\>5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'DAS28-CRP (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.386', 'spread': '1.3229', 'groupId': 'OG000'}, {'value': '3.561', 'spread': '1.3123', 'groupId': 'OG001'}, {'value': '3.594', 'spread': '1.2572', 'groupId': 'OG002'}]}]}, {'title': 'DAS28-CRP (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.072', 'spread': '0.9150', 'groupId': 'OG000'}, {'value': '-0.004', 'spread': '0.8190', 'groupId': 'OG001'}, {'value': '-0.154', 'spread': '0.6840', 'groupId': 'OG002'}]}]}, {'title': 'DAS28-CRP (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.157', 'spread': '0.9502', 'groupId': 'OG000'}, {'value': '-0.168', 'spread': '0.8421', 'groupId': 'OG001'}, {'value': '-0.162', 'spread': '0.7970', 'groupId': 'OG002'}]}]}, {'title': 'DAS28-CRP (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.236', 'spread': '1.0361', 'groupId': 'OG000'}, {'value': '-0.269', 'spread': '0.9759', 'groupId': 'OG001'}, {'value': '-0.215', 'spread': '1.0584', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.905', 'spread': '0.7050', 'groupId': 'OG000'}, {'value': '0.893', 'spread': '0.6691', 'groupId': 'OG001'}, {'value': '0.883', 'spread': '0.6109', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.024', 'spread': '0.3126', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.2989', 'groupId': 'OG001'}, {'value': '0.008', 'spread': '0.2942', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.046', 'spread': '0.3502', 'groupId': 'OG000'}, {'value': '-0.027', 'spread': '0.2758', 'groupId': 'OG001'}, {'value': '0.030', 'spread': '0.2950', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.079', 'spread': '0.3869', 'groupId': 'OG000'}, {'value': '-0.022', 'spread': '0.3521', 'groupId': 'OG001'}, {'value': '0.001', 'spread': '0.3800', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'description': 'DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \\<2.6=remission, \\<3.2=low disease activity, \\>=3.2-5.1=moderate disease activity and \\>5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'ACR/EULAR remission (Week 2)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ACR/EULAR remission (Week 4)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'ACR/EULAR remission (Week 6)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'ACR/EULAR remission (Week 12)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'ACR/EULAR remission (Week 14)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'ACR/EULAR remission (Week 22)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'ACR/EULAR remission (Week 30, pre-dose)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 2)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 4)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 6)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 12)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 14)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 22)', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'DAS remission (Week 30, pre-dose)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)', 'description': "ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=\\<) 1 or the score on the simplified disease activity index (SDAI) was =\\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \\<3.2: low disease activity, DAS28 \\<2.6: remission.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'ACR/EULAR remission (Week 38)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'ACR/EULAR remission (Week 46)', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'ACR/EULAR remission (Week 54, pre-dose)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'DAS remission (Week 38)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'DAS remission (Week 46)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'DAS remission (Week 54, pre-dose)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 38, 46 and 54 (pre-dose)', 'description': 'ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =\\<1 or the score on the SDAI was =\\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \\<3.2: low disease activity, DAS28 \\<2.6: remission.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'ACR/EULAR remission (Week 62)', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'ACR/EULAR remission (Week 70)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'ACR/EULAR remission (Week 78)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'DAS remission (Week 62)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'DAS remission (Week 70)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'DAS remission (Week 78)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 62, 70 and 78', 'description': 'ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =\\<1 or the score on the SDAI was =\\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \\<3.2: low disease activity, DAS28 \\<2.6: remission.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'Week 2 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Week 14 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Week 22 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Week 22 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'Week 22 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Week 30 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Week 30 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': 'Week 30 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)', 'description': 'EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \\>1.2 with DAS28 =\\<3.2; moderate response = DAS28 change of \\>0.6 to =\\<1.2 with DAS28 \\>3.2-5.1 and no-response = DAS28 change of =\\<0.6 with DAS28 \\>5.1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'Week 38 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Week 38 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}]}, {'title': 'Week 38 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Week 46 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Week 46 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}, {'title': 'Week 46 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}, {'title': 'Week 54 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 38, 46 and Week 54 (pre-dose)', 'description': 'EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \\>1.2 with DAS28 =\\<3.2; moderate response = DAS28 change of \\>0.6 to =\\<1.2 with DAS28 \\>3.2-5.1 and no-response = DAS28 change of =\\<0.6 with DAS28 \\>5.1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'Week 62 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Week 62 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Week 62 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Week 70 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Week 70 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'Week 70 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 (good response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 (moderate response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Week 78 (no response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 62, 70 and Week 78', 'description': 'EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \\>1.2 with DAS28 =\\<3.2; moderate response = DAS28 change of \\>0.6 to =\\<1.2 with DAS28 \\>3.2-5.1 and no-response = DAS28 change of =\\<0.6 with DAS28 \\>5.1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Treatment related TEAEs', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Treatment related SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Treatment related TEAEs', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Treatment related SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Treatment related TEAEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Treatment related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'TEAEs (Grade 3)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs (Grade 4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs (Grade 5)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'TEAEs (Grade 3)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs (Grade 4)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs (Grade 5)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'TEAEs (Grade 3)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs (Grade 4)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'TEAEs (Grade 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \\<0.8\\*lower limit of normal (LLN); platelets: \\>1.75\\*upper limit of normal (ULN); white blood cell count: \\<0.6\\*LLN; basophils, eosinophils, monocytes: \\>1.2\\*ULN. liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \\<0.8\\*lower limit of normal (LLN); platelets: \\>1.75\\*upper limit of normal (ULN); white blood cell count: \\<0.6\\*LLN; basophils, eosinophils, monocytes: \\>1.2\\*ULN. liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \\<0.8\\*lower limit of normal (LLN); platelets: \\>1.75\\*upper limit of normal (ULN); white blood cell count: \\<0.6\\*LLN; basophils, eosinophils, monocytes: \\>1.2\\*ULN. liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'Tender joint count (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.7', 'spread': '13.90', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '12.89', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': '8.78', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '8.39', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '10.02', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '9.41', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'spread': '11.17', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '10.12', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '11.84', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '11.51', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.8', 'spread': '12.50', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '12.15', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.2', 'spread': '12.62', 'groupId': 'OG000'}, {'value': '-15.2', 'spread': '12.93', 'groupId': 'OG001'}]}]}, {'title': 'Tender joint count (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.4', 'spread': '13.19', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '12.57', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.1', 'spread': '9.44', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '8.70', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '6.89', 'groupId': 'OG000'}, {'value': '-5.7', 'spread': '7.27', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '7.75', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '7.39', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '7.99', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '7.92', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '8.61', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '8.39', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '-9.6', 'spread': '8.44', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '8.77', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '7.94', 'groupId': 'OG001'}]}]}, {'title': 'Swollen joint count (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.0', 'spread': '9.33', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '8.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30', 'description': "Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.", 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'Tender joint count (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '11.96', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '8.89', 'groupId': 'OG002'}]}]}, {'title': 'Tender joint count (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '8.86', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '6.03', 'groupId': 'OG002'}]}]}, {'title': 'Tender joint count (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '7.87', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '9.32', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '7.77', 'groupId': 'OG002'}]}]}, {'title': 'Tender joint count (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '7.96', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '10.23', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '9.03', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': '6.46', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '5.35', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '4.90', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '3.93', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '5.54', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '4.22', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.52', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.02', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '4.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and Week 54', 'description': "Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.", 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'Tender joint count (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '9.51', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '9.21', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '7.99', 'groupId': 'OG002'}]}]}, {'title': 'Tender joint count (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '5.21', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '5.18', 'groupId': 'OG002'}]}]}, {'title': 'Tender joint count (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '5.14', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '5.51', 'groupId': 'OG002'}]}]}, {'title': 'Tender joint count (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '5.82', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '6.63', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '5.16', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '4.28', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '4.41', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '2.72', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.12', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '2.48', 'groupId': 'OG002'}]}]}, {'title': 'Swollen joint count (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '4.00', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '3.14', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'description': "Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.", 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'PAAP (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.514', 'spread': '20.5903', 'groupId': 'OG000'}, {'value': '63.098', 'spread': '21.5442', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.724', 'spread': '21.9589', 'groupId': 'OG000'}, {'value': '-15.360', 'spread': '19.4328', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.609', 'spread': '22.3825', 'groupId': 'OG000'}, {'value': '-20.552', 'spread': '21.2670', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.917', 'spread': '25.0213', 'groupId': 'OG000'}, {'value': '-22.797', 'spread': '22.9133', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.364', 'spread': '25.6602', 'groupId': 'OG000'}, {'value': '-25.829', 'spread': '24.8304', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.131', 'spread': '26.8712', 'groupId': 'OG000'}, {'value': '-25.077', 'spread': '25.0536', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.844', 'spread': '27.0039', 'groupId': 'OG000'}, {'value': '-25.788', 'spread': '25.3225', 'groupId': 'OG001'}]}]}, {'title': 'PAAP (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.150', 'spread': '27.9802', 'groupId': 'OG000'}, {'value': '-28.853', 'spread': '26.7252', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.340', 'spread': '20.7209', 'groupId': 'OG000'}, {'value': '63.752', 'spread': '22.9105', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.262', 'spread': '22.8767', 'groupId': 'OG000'}, {'value': '-16.504', 'spread': '20.3188', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.393', 'spread': '23.3769', 'groupId': 'OG000'}, {'value': '-21.355', 'spread': '23.6005', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '314', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.536', 'spread': '24.8041', 'groupId': 'OG000'}, {'value': '-23.314', 'spread': '24.2005', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.882', 'spread': '25.3270', 'groupId': 'OG000'}, {'value': '-26.535', 'spread': '26.3998', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-27.583', 'spread': '26.7955', 'groupId': 'OG000'}, {'value': '-25.323', 'spread': '26.8562', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.558', 'spread': '27.5077', 'groupId': 'OG000'}, {'value': '-26.486', 'spread': '26.7141', 'groupId': 'OG001'}]}]}, {'title': 'PGA (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.186', 'spread': '28.6488', 'groupId': 'OG000'}, {'value': '-28.814', 'spread': '28.5929', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.362', 'spread': '16.2520', 'groupId': 'OG000'}, {'value': '64.126', 'spread': '16.7220', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21.913', 'spread': '18.5574', 'groupId': 'OG000'}, {'value': '-20.143', 'spread': '17.1407', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '315', 'groupId': 'OG000'}, {'value': '321', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.724', 'spread': '19.2226', 'groupId': 'OG000'}, {'value': '-27.905', 'spread': '17.9803', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.319', 'spread': '20.1143', 'groupId': 'OG000'}, {'value': '-30.958', 'spread': '18.9303', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.827', 'spread': '19.8162', 'groupId': 'OG000'}, {'value': '-33.919', 'spread': '19.7020', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 14)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.870', 'spread': '21.4707', 'groupId': 'OG000'}, {'value': '-34.175', 'spread': '20.6526', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '311', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-37.542', 'spread': '20.8619', 'groupId': 'OG000'}, {'value': '-36.118', 'spread': '20.6564', 'groupId': 'OG001'}]}]}, {'title': 'PGAA (Change at Week 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-39.842', 'spread': '22.0276', 'groupId': 'OG000'}, {'value': '-36.666', 'spread': '22.1598', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30', 'description': 'PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant\'s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician\'s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'PAAP (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.137', 'spread': '24.2922', 'groupId': 'OG000'}, {'value': '33.331', 'spread': '22.2738', 'groupId': 'OG001'}, {'value': '32.559', 'spread': '22.2702', 'groupId': 'OG002'}]}]}, {'title': 'PAAP (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.014', 'spread': '18.7502', 'groupId': 'OG000'}, {'value': '1.440', 'spread': '14.9902', 'groupId': 'OG001'}, {'value': '-0.705', 'spread': '18.9147', 'groupId': 'OG002'}]}]}, {'title': 'PAAP (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.230', 'spread': '20.0201', 'groupId': 'OG000'}, {'value': '1.087', 'spread': '21.5811', 'groupId': 'OG001'}, {'value': '2.188', 'spread': '20.7319', 'groupId': 'OG002'}]}]}, {'title': 'PAAP (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.416', 'spread': '20.7823', 'groupId': 'OG000'}, {'value': '-0.492', 'spread': '20.8000', 'groupId': 'OG001'}, {'value': '1.365', 'spread': '24.8362', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.104', 'spread': '24.8444', 'groupId': 'OG000'}, {'value': '33.268', 'spread': '22.2621', 'groupId': 'OG001'}, {'value': '34.029', 'spread': '22.7172', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.628', 'spread': '19.1471', 'groupId': 'OG000'}, {'value': '1.582', 'spread': '16.0776', 'groupId': 'OG001'}, {'value': '-1.086', 'spread': '17.5787', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.171', 'spread': '20.3050', 'groupId': 'OG000'}, {'value': '0.558', 'spread': '20.6610', 'groupId': 'OG001'}, {'value': '0.535', 'spread': '21.3947', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.929', 'spread': '20.9396', 'groupId': 'OG000'}, {'value': '-0.538', 'spread': '21.1331', 'groupId': 'OG001'}, {'value': '0.776', 'spread': '23.8743', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.124', 'spread': '19.0943', 'groupId': 'OG000'}, {'value': '27.294', 'spread': '18.8148', 'groupId': 'OG001'}, {'value': '26.091', 'spread': '17.9503', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Change at Week 38)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.254', 'spread': '12.4789', 'groupId': 'OG000'}, {'value': '0.588', 'spread': '16.5232', 'groupId': 'OG001'}, {'value': '-1.852', 'spread': '15.4699', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Change at Week 46)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.470', 'spread': '13.9135', 'groupId': 'OG000'}, {'value': '0.625', 'spread': '20.0163', 'groupId': 'OG001'}, {'value': '-0.700', 'spread': '18.8038', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Change at Week 54)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.252', 'spread': '17.0422', 'groupId': 'OG000'}, {'value': '-3.398', 'spread': '20.0381', 'groupId': 'OG001'}, {'value': '-2.969', 'spread': '20.1498', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and 54', 'description': 'PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant\'s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician\'s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3", 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'PAAP (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.395', 'spread': '23.7412', 'groupId': 'OG000'}, {'value': '31.659', 'spread': '23.2900', 'groupId': 'OG001'}, {'value': '31.225', 'spread': '22.9366', 'groupId': 'OG002'}]}]}, {'title': 'PAAP (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '15.8259', 'groupId': 'OG000'}, {'value': '0.276', 'spread': '12.2744', 'groupId': 'OG001'}, {'value': '-1.790', 'spread': '16.6740', 'groupId': 'OG002'}]}]}, {'title': 'PAAP (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.948', 'spread': '18.1105', 'groupId': 'OG000'}, {'value': '-0.297', 'spread': '15.4108', 'groupId': 'OG001'}, {'value': '-0.970', 'spread': '16.7170', 'groupId': 'OG002'}]}]}, {'title': 'PAAP (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.552', 'spread': '18.8760', 'groupId': 'OG000'}, {'value': '-2.900', 'spread': '18.0663', 'groupId': 'OG001'}, {'value': '-3.918', 'spread': '20.9632', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.841', 'spread': '23.7807', 'groupId': 'OG000'}, {'value': '31.130', 'spread': '23.3603', 'groupId': 'OG001'}, {'value': '32.710', 'spread': '22.6365', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.240', 'spread': '16.2724', 'groupId': 'OG000'}, {'value': '1.463', 'spread': '13.6899', 'groupId': 'OG001'}, {'value': '-2.226', 'spread': '15.3415', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.764', 'spread': '18.7038', 'groupId': 'OG000'}, {'value': '0.101', 'spread': '14.4260', 'groupId': 'OG001'}, {'value': '-2.093', 'spread': '16.2677', 'groupId': 'OG002'}]}]}, {'title': 'PGA (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.880', 'spread': '19.6643', 'groupId': 'OG000'}, {'value': '-2.339', 'spread': '17.0453', 'groupId': 'OG001'}, {'value': '-3.758', 'spread': '19.5447', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.305', 'spread': '17.6278', 'groupId': 'OG000'}, {'value': '21.780', 'spread': '17.3354', 'groupId': 'OG001'}, {'value': '20.705', 'spread': '16.9587', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Change at Week 62)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.381', 'spread': '13.6810', 'groupId': 'OG000'}, {'value': '2.659', 'spread': '14.6314', 'groupId': 'OG001'}, {'value': '-0.499', 'spread': '12.9483', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Change at Week 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.217', 'spread': '14.1581', 'groupId': 'OG000'}, {'value': '-1.160', 'spread': '12.7665', 'groupId': 'OG001'}, {'value': '-0.810', 'spread': '15.0274', 'groupId': 'OG002'}]}]}, {'title': 'PGAA (Change at Week 78)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.217', 'spread': '15.3894', 'groupId': 'OG000'}, {'value': '0.681', 'spread': '15.0989', 'groupId': 'OG001'}, {'value': '-0.159', 'spread': '17.2024', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'description': 'PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant\'s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician\'s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.916', 'spread': '24.3118', 'groupId': 'OG000'}, {'value': '25.366', 'spread': '28.4866', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.183', 'spread': '20.8107', 'groupId': 'OG000'}, {'value': '-16.140', 'spread': '24.2442', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '312', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.555', 'spread': '19.5227', 'groupId': 'OG000'}, {'value': '-13.407', 'spread': '33.9136', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.078', 'spread': '20.4984', 'groupId': 'OG000'}, {'value': '-13.247', 'spread': '27.7801', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.502', 'spread': '23.9435', 'groupId': 'OG000'}, {'value': '-12.525', 'spread': '27.8736', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.613', 'spread': '23.2548', 'groupId': 'OG000'}, {'value': '-12.392', 'spread': '29.3267', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.195', 'spread': '24.5225', 'groupId': 'OG000'}, {'value': '-11.422', 'spread': '31.0610', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.165', 'spread': '25.6612', 'groupId': 'OG000'}, {'value': '-12.390', 'spread': '30.0352', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30', 'unitOfMeasure': 'milligram/litres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.970', 'spread': '19.1927', 'groupId': 'OG000'}, {'value': '14.427', 'spread': '21.1595', 'groupId': 'OG001'}, {'value': '10.847', 'spread': '14.8018', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 38', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.496', 'spread': '18.7859', 'groupId': 'OG000'}, {'value': '1.805', 'spread': '19.5138', 'groupId': 'OG001'}, {'value': '0.093', 'spread': '14.8441', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 46', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.210', 'spread': '16.1727', 'groupId': 'OG000'}, {'value': '3.996', 'spread': '24.4986', 'groupId': 'OG001'}, {'value': '0.798', 'spread': '15.7687', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.639', 'spread': '21.1226', 'groupId': 'OG000'}, {'value': '2.988', 'spread': '24.5492', 'groupId': 'OG001'}, {'value': '1.264', 'spread': '13.6788', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and 54', 'unitOfMeasure': 'milligrams/litres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all participants who were randomized to study treatment. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.112', 'spread': '21.3781', 'groupId': 'OG000'}, {'value': '16.096', 'spread': '24.1595', 'groupId': 'OG001'}, {'value': '11.985', 'spread': '13.8159', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.635', 'spread': '19.9660', 'groupId': 'OG000'}, {'value': '-3.648', 'spread': '21.6177', 'groupId': 'OG001'}, {'value': '-0.541', 'spread': '9.3198', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 70', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.320', 'spread': '23.1234', 'groupId': 'OG000'}, {'value': '-4.199', 'spread': '22.3368', 'groupId': 'OG001'}, {'value': '-0.339', 'spread': '11.7095', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.660', 'spread': '19.6340', 'groupId': 'OG000'}, {'value': '-3.565', 'spread': '23.9800', 'groupId': 'OG001'}, {'value': '0.811', 'spread': '14.7061', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'unitOfMeasure': 'milligrams/litres', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions of INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}, {'title': 'NAb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'ADA positive results was defined as ADA titer level \\>=1.30 and NAb positive was defined as NAb titer level \\>=0.70.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'NAb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'ADA positive results was defined as ADA titer level \\>=1.30 and NAb positive was defined as NAb titer level \\>=0.70.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'ADA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'NAb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'ADA positive results was defined as ADA titer level \\>=1.30 and NAb positive was defined as NAb titer level \\>=0.70.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration Versus Time Summary: Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 1: PF-06438179', 'description': 'Participants were scheduled to receive intravenous infusions of PF-06438179 at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}, {'id': 'OG001', 'title': 'Period 1: Infliximab-EU Remicade (INX)', 'description': 'Participants were scheduled to receive intravenous infusions INX at a dose of 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessment. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks.'}], 'classes': [{'title': 'Day 1 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1635', 'spread': '11163', 'groupId': 'OG000'}, {'value': '656.2', 'spread': '6583.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (2 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65310', 'spread': '24920', 'groupId': 'OG000'}, {'value': '62220', 'spread': '22129', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '323', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17350', 'spread': '8391.4', 'groupId': 'OG000'}, {'value': '16690', 'spread': '8002.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (336 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23640', 'spread': '12357', 'groupId': 'OG000'}, {'value': '21570', 'spread': '10986', 'groupId': 'OG001'}]}]}, {'title': 'Day 43 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11440', 'spread': '10101', 'groupId': 'OG000'}, {'value': '10100', 'spread': '7721.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 99 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3547', 'spread': '9559.2', 'groupId': 'OG000'}, {'value': '2559', 'spread': '6360.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 99 (2 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76030', 'spread': '39407', 'groupId': 'OG000'}, {'value': '73350', 'spread': '41410', 'groupId': 'OG001'}]}]}, {'title': 'Day 155 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2051', 'spread': '3440.9', 'groupId': 'OG000'}, {'value': '1566', 'spread': '2321.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 211 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1781', 'spread': '2765.2', 'groupId': 'OG000'}, {'value': '2112', 'spread': '11703', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29', 'unitOfMeasure': 'nanograms/milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration Versus Time Summary: Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 2: PF-06438179/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of PF-06438179 in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG001', 'title': 'Period 2: INX/INX', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive INX in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}, {'id': 'OG002', 'title': 'Period 2: INX/PF-06438179', 'description': 'Participants randomized to receive intravenous infusions of INX in Period 1 were scheduled to receive PF-06438179 in Period 2 at a dose of 3 mg/kg or 5 mg/kg on Weeks 30, 38 and 46. Period 2 ended with the completion of the Week 54 pre-dose assessments.'}], 'classes': [{'title': 'Day 211 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1801', 'spread': '2773.4', 'groupId': 'OG000'}, {'value': '1083', 'spread': '1763.6', 'groupId': 'OG001'}, {'value': '1819', 'spread': '2393.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 267 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1855', 'spread': '2871.7', 'groupId': 'OG000'}, {'value': '1208', 'spread': '1926.5', 'groupId': 'OG001'}, {'value': '1620', 'spread': '2413.7', 'groupId': 'OG002'}]}]}, {'title': 'Day 379 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2075', 'spread': '4054.6', 'groupId': 'OG000'}, {'value': '1823', 'spread': '6110.8', 'groupId': 'OG001'}, {'value': '1734', 'spread': '2725.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 547 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '499.6', 'spread': '1373.0', 'groupId': 'OG000'}, {'value': '212.7', 'spread': '405.18', 'groupId': 'OG001'}, {'value': '3305', 'spread': '8429.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose on Day 211, 267, 379 and 547', 'unitOfMeasure': 'nanograms/milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Serum Concentration Versus Time Summary: Period 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Period 3: PF-06438179/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG001', 'title': 'Period 3: INX/INX/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}, {'id': 'OG002', 'title': 'Period 3: INX/PF-06438179/PF-06438179', 'description': 'Participants received intravenous infusions of INX in Period 1 and PF-06438179 in Period 2. In Period 3 they were scheduled to receive PF-06438179 at a dose of 3 mg/kg or 5 mg/kg on Weeks 54, 62 and 70. Period 3 ended at Week 78.'}], 'classes': [{'title': 'Day 379 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2078', 'spread': '4044.0', 'groupId': 'OG000'}, {'value': '1823', 'spread': '6110.8', 'groupId': 'OG001'}, {'value': '1734', 'spread': '2725.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 435 (0 hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1913', 'spread': '2838.0', 'groupId': 'OG000'}, {'value': '1388', 'spread': '2387.4', 'groupId': 'OG001'}, {'value': '1572', 'spread': '2543.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 547', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1707', 'spread': '2512.9', 'groupId': 'OG000'}, {'value': '1663', 'spread': '5305.7', 'groupId': 'OG001'}, {'value': '1482', 'spread': '2441.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre dose on Day 379, 435 and 547', 'unitOfMeasure': 'nanograms/milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.'}, {'id': 'FG001', 'title': 'Infliximab-EU Remicade (INX)', 'description': 'Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.'}], 'periods': [{'title': 'Period 1: First Dose-Week 30 (Pre-dose)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '326'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '326'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Week30 Dosing-Week54(Pre-dose)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '423'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '380'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Period 3: Week 54 Dosing-Week 78 Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '505'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '474'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "A total of 1603 participants were screened after signing an informed consent form, of whom 650 participants were randomized to receive study treatment. One (1) participant in the PF-06438179 arm was screened and randomized by 2 different study site personnel, and no data were collected for the participant's second randomization."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '650', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-06438179', 'description': 'Participants received intravenous infusions of PF-06438179 at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2, when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.'}, {'id': 'BG001', 'title': 'Infliximab-EU Remicade (INX)', 'description': 'Participants received intravenous infusions of INX at 3 mg/kg on Weeks 0, 2, 6 followed by a maintenance dose every 8 weeks at Weeks 14 and 22 in Period 1 which ended with the completion of the Week 30 pre-dose assessments. For participants who failed to achieve a minimum clinical response or lost clinical response (after Week 14 assessments), dose was increased to 5 mg/kg per infusion every 8 weeks. Participants initially randomized to PF-06438179 continued to blindly receive PF-06438179 in Period 2. A second randomization was blindly performed prior to dosing at Week 30 (at the beginning of Period 2), when participants initially randomized to INX were re-randomized in a 1:1 ratio, with 50% of the participants switching to PF-06438179 and the other 50% of participants remaining on the INX arm. Period 3 started with dosing at Week 54 where all participants began open label treatment with PF-06438179.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '13.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) Population was defined as all participants who were randomized to study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'dispFirstSubmitDate': '2017-06-26', 'completionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2014-08-19', 'dispFirstSubmitQcDate': '2017-06-26', 'resultsFirstSubmitDate': '2017-06-26', 'studyFirstSubmitQcDate': '2014-08-19', 'dispFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-09', 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1', 'timeFrame': 'Week 14', 'description': 'ACR20 response: greater than or equal to (\\>=) 20 percent (%) improvement in tender joint count (TJC); \\>= 20% improvement in swollen joint count (SJC); and \\>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index \\[HAQ-DI\\]); and C-Reactive Protein (CRP).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1', 'timeFrame': 'Week 2, 4, 6, 12, 22 and 30 (pre-dose)', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.'}, {'measure': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2', 'timeFrame': 'Week 38, 46 and 54 (pre-dose)', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.'}, {'measure': 'Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3', 'timeFrame': 'Week 62, 70 and 78', 'description': 'ACR20 response: \\>=20% improvement in tender joint count; \\>=20% improvement in swollen joint count; and \\>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.'}, {'measure': 'Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1', 'timeFrame': 'Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)', 'description': 'ACR50 response: \\>=50% improvement in tender joint count, \\>=50% improvement in swollen joint count improvement and \\>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \\>=70% improvement in tender joint count, \\>=70% improvement in swollen joint count improvement and \\>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.'}, {'measure': 'Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2', 'timeFrame': 'Week 38, 46 and 54 (pre-dose)', 'description': 'ACR50 response: \\>=50% improvement in tender joint count, \\>=50% improvement in swollen joint count improvement and \\>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \\>=70% improvement in tender joint count, \\>=70% improvement in swollen joint count improvement and \\>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.'}, {'measure': 'Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3', 'timeFrame': 'Week 62, 70 and 78', 'description': 'ACR50 response: \\>=50% improvement in tender joint count, \\>=50% improvement in swollen joint count improvement and \\>=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: \\>=70% improvement in tender joint count, \\>=70% improvement in swollen joint count improvement and \\>=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.'}, {'measure': 'Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30', 'description': 'DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale \\[VAS\\] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (\\<)2.6=remission, \\<3.2=low disease activity, \\>=3.2-5.1=moderate disease activity and greater than (\\>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.'}, {'measure': 'Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and 54', 'description': 'DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter \\[mm\\]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \\<2.6=remission, \\<3.2=low disease activity, \\>=3.2-5.1=moderate disease activity and \\>5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.'}, {'measure': 'Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'description': 'DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) \\<2.6=remission, \\<3.2=low disease activity, \\>=3.2-5.1=moderate disease activity and \\>5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.'}, {'measure': 'Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1', 'timeFrame': 'Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)', 'description': "ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=\\<) 1 or the score on the simplified disease activity index (SDAI) was =\\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \\<3.2: low disease activity, DAS28 \\<2.6: remission."}, {'measure': 'Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2', 'timeFrame': 'Week 38, 46 and 54 (pre-dose)', 'description': 'ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =\\<1 or the score on the SDAI was =\\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \\<3.2: low disease activity, DAS28 \\<2.6: remission.'}, {'measure': 'Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3', 'timeFrame': 'Week 62, 70 and 78', 'description': 'ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =\\<1 or the score on the SDAI was =\\<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 \\<3.2: low disease activity, DAS28 \\<2.6: remission.'}, {'measure': 'Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1', 'timeFrame': 'Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)', 'description': 'EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \\>1.2 with DAS28 =\\<3.2; moderate response = DAS28 change of \\>0.6 to =\\<1.2 with DAS28 \\>3.2-5.1 and no-response = DAS28 change of =\\<0.6 with DAS28 \\>5.1.'}, {'measure': 'Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2', 'timeFrame': 'Week 38, 46 and Week 54 (pre-dose)', 'description': 'EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \\>1.2 with DAS28 =\\<3.2; moderate response = DAS28 change of \\>0.6 to =\\<1.2 with DAS28 \\>3.2-5.1 and no-response = DAS28 change of =\\<0.6 with DAS28 \\>5.1.'}, {'measure': 'Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3', 'timeFrame': 'Week 62, 70 and Week 78', 'description': 'EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of \\>1.2 with DAS28 =\\<3.2; moderate response = DAS28 change of \\>0.6 to =\\<1.2 with DAS28 \\>3.2-5.1 and no-response = DAS28 change of =\\<0.6 with DAS28 \\>5.1.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.'}, {'measure': 'Number of Participants With Laboratory Abnormalities: Period 1', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \\<0.8\\*lower limit of normal (LLN); platelets: \\>1.75\\*upper limit of normal (ULN); white blood cell count: \\<0.6\\*LLN; basophils, eosinophils, monocytes: \\>1.2\\*ULN. liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.'}, {'measure': 'Number of Participants With Laboratory Abnormalities: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \\<0.8\\*lower limit of normal (LLN); platelets: \\>1.75\\*upper limit of normal (ULN); white blood cell count: \\<0.6\\*LLN; basophils, eosinophils, monocytes: \\>1.2\\*ULN. liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.'}, {'measure': 'Number of Participants With Laboratory Abnormalities: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: \\<0.8\\*lower limit of normal (LLN); platelets: \\>1.75\\*upper limit of normal (ULN); white blood cell count: \\<0.6\\*LLN; basophils, eosinophils, monocytes: \\>1.2\\*ULN. liver function: bilirubin: \\>1.5\\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \\>3.0\\*ULN; protein, albumin: \\<0.8\\*LLN\\>\\</0\\>1.2\\*ULN; renal function:blood urea nitrogen,creatinine: \\>1.3\\*ULN; uric acid: \\>1.2\\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \\<0.9\\*LLN,\\>1.1\\*ULN; urinalysis: pH\\<4.5, \\>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \\<0.6\\*LLN,\\>1.5\\*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.'}, {'measure': 'Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30', 'description': "Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent."}, {'measure': 'Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and Week 54', 'description': "Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent."}, {'measure': 'Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'description': "Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent."}, {'measure': "Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1", 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30', 'description': 'PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant\'s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician\'s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.'}, {'measure': "Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2", 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and 54', 'description': 'PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant\'s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician\'s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.'}, {'measure': "Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3", 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78', 'description': 'PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant\'s disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician\'s response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.'}, {'measure': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1', 'timeFrame': 'Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30'}, {'measure': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose), Week 38, 46 and 54'}, {'measure': 'Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose), Week 62, 70 and 78'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1', 'timeFrame': 'Baseline (Day 1) up to Week 30', 'description': 'ADA positive results was defined as ADA titer level \\>=1.30 and NAb positive was defined as NAb titer level \\>=0.70.'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2', 'timeFrame': 'Baseline (Week 30 pre-dose) up to Week 54', 'description': 'ADA positive results was defined as ADA titer level \\>=1.30 and NAb positive was defined as NAb titer level \\>=0.70.'}, {'measure': 'Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3', 'timeFrame': 'Baseline (Week 54 pre-dose) up to Week 78', 'description': 'ADA positive results was defined as ADA titer level \\>=1.30 and NAb positive was defined as NAb titer level \\>=0.70.'}, {'measure': 'Serum Concentration Versus Time Summary: Period 1', 'timeFrame': 'Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29'}, {'measure': 'Serum Concentration Versus Time Summary: Period 2', 'timeFrame': 'Pre dose on Day 211, 267, 379 and 547'}, {'measure': 'Serum Concentration Versus Time Summary: Period 3', 'timeFrame': 'Pre dose on Day 379, 435 and 547'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 3', 'infliximab', 'rheumatoid arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '36180101', 'type': 'DERIVED', 'citation': 'Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 Sep;8(2):e002423. doi: 10.1136/rmdopen-2022-002423.'}, {'pmid': '31939063', 'type': 'DERIVED', 'citation': 'Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z.'}, {'pmid': '31284794', 'type': 'DERIVED', 'citation': 'Palaparthy R, Rehman MI, von Richter O, Yin D. Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis. Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8.'}, {'pmid': '30997153', 'type': 'DERIVED', 'citation': 'Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019.'}, {'pmid': '30053896', 'type': 'DERIVED', 'citation': 'Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5371002&StudyName=A%20Study%20of%20PF-06438179%20%28Infliximab-Pfizer%29%20and%20Infliximab%20in%20Combination%20with%20Methotrexate%20in%20Subjects%20with%20Active%20Rheumatoid%20Arthritis%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.\n\nAt least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.\n\nHS-CRP equal or greater than 10 mg/L.\n\nMust have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.\n\nExclusion Criteria:\n\nEvidence of untreated or inadequately treated latent or active TB.\n\nEvidence or history of moderate or severe heart failure (NYHA Class III/IV)\n\nInfection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.'}, 'identificationModule': {'nctId': 'NCT02222493', 'briefTitle': 'A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate', 'orgStudyIdInfo': {'id': 'B5371002'}, 'secondaryIdInfos': [{'id': 'REFLECTIONS B537-02', 'type': 'OTHER', 'domain': 'Alias ID'}, {'id': '2013-004148-49', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-06438179', 'interventionNames': ['Biological: PF-06438179']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infliximab', 'interventionNames': ['Biological: Infliximab']}], 'interventions': [{'name': 'PF-06438179', 'type': 'BIOLOGICAL', 'otherNames': ['Infliximab-Pfizer'], 'description': 'PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.', 'armGroupLabels': ['PF-06438179']}, {'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Infliximab-EU, Remicade'], 'description': 'Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.', 'armGroupLabels': ['Infliximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical and Translational Research Center of Alabama, PC', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sun Valley Arthritis Center, Ltd.', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85037', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Associates, P.C.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90623', 'city': 'La Palma', 'state': 'California', 'country': 'United States', 'facility': 'Arthritis & Osteoporosis Medical Center', 'geoPoint': {'lat': 33.8464, 'lon': -118.04673}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Inland Rheumatology Clinical Trials, Inc.', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '92395', 'city': 'Victorville', 'state': 'California', 'country': 'United States', 'facility': 'Desert Valley Medical Group', 'geoPoint': {'lat': 34.53611, 'lon': -117.29116}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Javed Rheumatology Associates, Inc', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis and Rheumatic Disease Specialties', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'International Medical Research', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'San Marcus Research Clinic, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advance Medical Research Services Corporation', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Arthritis Research Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Alastair C. Kennedy, MD', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Indian River Primary Care', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '30165', 'city': 'Rome', 'state': 'Georgia', 'country': 'United States', 'facility': 'Harbin Clinic', 'geoPoint': {'lat': 34.25704, 'lon': -85.16467}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Advanced Clinical Research', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '61636', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Medical Center of IL', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': "Physician's Clinic of Iowa, P.C.", 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Gilbert-Graves Clinic', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '42101', 'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Graves-Gilbert Clinic Bowling Green', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Baton Rouge', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '71203', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Arthritis and Diabetes Clinic, Inc.', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Rheumatology and Bone Research', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'zip': '49015', 'city': 'Battle Creek', 'state': 'Michigan', 'country': 'United States', 'facility': 'Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research', 'geoPoint': {'lat': 42.3173, 'lon': -85.17816}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Arthritis, Rheumatic & Back Disease Associates', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '58701', 'city': 'Minot', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Trinity Health Center-Medical Arts', 'geoPoint': {'lat': 48.23251, 'lon': -101.29627}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '19610', 'city': 'Wyomissing', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Research Center of Reading, LLC', 'geoPoint': {'lat': 40.32954, 'lon': -75.96521}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Low Country Rheumatology, PA', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Regional Health Clinical Research', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Regional Medical Clinic', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'West Tennessee Research Institute', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Ramesh C Gupta, MD', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Regional Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research, Inc.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77058', 'city': 'Nassau Bay', 'state': 'Texas', 'country': 'United States', 'facility': 'Accurate Clinical Research', 'geoPoint': {'lat': 29.54468, 'lon': -95.09104}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pharmacy Services, Sentara Leigh Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Medical Group, Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98133', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'The Seattle Arthritis Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast Private Hospital Pty Ltd', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'HPS Pharmacies', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Paradise Arthritis and Rheumatology Pty Ltd', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '6017', 'city': 'Osborne Park', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'CliniPath Pathology', 'geoPoint': {'lat': -31.90066, 'lon': 115.81083}}, {'zip': '6100', 'city': 'Victoria Park', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'R.K. Will Pty Ltd', 'geoPoint': {'lat': -31.97619, 'lon': 115.90525}}, {'zip': '71000', 'city': 'Sarajevo', 'state': 'Kanton Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'Clinical Center University of Sarajevo', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'zip': '71000', 'city': 'Sarajevo', 'state': 'Kanton Sarajevo', 'country': 'Bosnia and Herzegovina', 'facility': 'General Hospital "Prim.dr.Abdulah Nakas"', 'geoPoint': {'lat': 43.84864, 'lon': 18.35644}}, {'zip': '75000', 'city': 'Tuzla', 'state': 'Tuzlanski Kanton', 'country': 'Bosnia and Herzegovina', 'facility': 'University Clinical Center Tuzla', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}, {'zip': '78000', 'city': 'Banja Luka', 'country': 'Bosnia and Herzegovina', 'facility': 'University Hospital Clinical Center Banja Luka', 'geoPoint': {'lat': 44.77879, 'lon': 17.20629}}, {'zip': '80030-110', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'CETI - Centro de Estudos em Terapias Inovadoras', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '05652-900', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment Trimontium OOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'N8X 2C9', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Clinical Research and Arthritis Center', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': '602 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'CCBR Czech Brno, s.r.o.', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '602 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Lekarna Lancier, s.r.o.', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'BENU Lekarna', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '530 02', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'CCBR-SYNARC a.s.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '130 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'CCBR Czech Prague, s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '130 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Lekarna U Robina, s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '686 01', 'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'Lekarna Hradebni s.r.o.', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'zip': '686 01', 'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'MEDICAL PLUS, s.r.o.', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Tbilisi Central Hospital', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Unimedi Kakheti', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Tbilisi Heart and Vascular Clinic LTD', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD MediClubGeorgia', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Adapti', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0186', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Medulla" Chemotherapy and Immunotherapy Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Schlosspark-Klinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '59939', 'city': 'Olsberg', 'country': 'Germany', 'facility': 'Elisabeth-Klinik gGmbH', 'geoPoint': {'lat': 51.35613, 'lon': 8.48899}}, {'zip': '66346', 'city': 'Püttlingen', 'country': 'Germany', 'facility': 'Knappschaftsklinikum Saar GmbH', 'geoPoint': {'lat': 49.2855, 'lon': 6.88723}}, {'zip': '40878', 'city': 'Ratingen', 'country': 'Germany', 'facility': 'Rheumazentrum Ratingen', 'geoPoint': {'lat': 51.29724, 'lon': 6.84929}}, {'zip': '01010', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Clínica Médica Especializada en Medicina Interna y Reumatología', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01011', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Clínica Médica especializada en Medicina Interna', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01015', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '01015', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Therapeutic Research Institute and Lab S.A', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '8230', 'city': 'Balatonfüred', 'country': 'Hungary', 'facility': 'DRC Gyógyszervizsgáló Központ Kft.', 'geoPoint': {'lat': 46.96188, 'lon': 17.87187}}, {'zip': '1036', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Qualiclinic Kft.', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '446-8602', 'city': 'Anjo-shi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Anjo Kosei Hospital'}, {'zip': '820-8505', 'city': 'Iiduka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Aso Iizuka Hospital'}, {'zip': '370-0053', 'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Inoue Hospital', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'zip': '735-8585', 'city': 'Aki-gun', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Mazda Hospital'}, {'zip': '060-8604', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo City General Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '673-1462', 'city': 'Katoh', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Matsubara Mayflower Hospital'}, {'zip': '252-0392', 'city': 'Sagamihara', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'National Hospital Organization Sagamihara National Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'zip': '236-0037', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama Minami Kyosai Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '856-8562', 'city': 'Ōmura', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'National Hospital Organization Nagasaki Medical Center', 'geoPoint': {'lat': 32.92139, 'lon': 129.95389}}, {'zip': '857-1195', 'city': 'Sasebo', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Sasebo Chuo Hospital', 'geoPoint': {'lat': 33.16834, 'lon': 129.72502}}, {'zip': '710-0016', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kurashiki Sweet Hospital', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '901-0243', 'city': 'Tomigusuku', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'Yuaikai Tomishiro Central Hospital', 'geoPoint': {'lat': 26.18583, 'lon': 127.68192}}, {'zip': '350-8550', 'city': 'Kawagoe-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Medical Center'}, {'zip': '359-1111', 'city': 'Tokorozawa-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Hirose Clinic'}, {'zip': '411-8611', 'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Shizuoka Medical Center'}, {'zip': '104-8560', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': "St. Luke's International Hospital"}, {'zip': '153-8515', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Ohashi Medical Center'}, {'zip': '142-8666', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Showa University Hospital'}, {'zip': '260-8712', 'city': 'Chiba', 'country': 'Japan', 'facility': 'National Hospital Organization Chiba-East Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '810-0001', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Kondo clinic for rheumatism and orthopaedics', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '810-8563', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Medical Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '862-0976', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto Orthopaedic Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '11152', 'city': 'Amman', 'country': 'Jordan', 'facility': 'Jordan Hospital', 'geoPoint': {'lat': 31.95522, 'lon': 35.94503}}, {'zip': '22110', 'city': 'Irbid', 'country': 'Jordan', 'facility': 'King Abdullah University Hospital', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}, {'zip': 'LT-50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'LSMUL Kauno klinikos', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': '78213', 'city': 'San Luis de Potosí', 'state': 'SAN LUIS de Potosi', 'country': 'Mexico', 'facility': 'Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.'}, {'zip': 'CP 78240', 'city': 'Zona Universitaria', 'state': 'SAN LUIS de Potosi', 'country': 'Mexico', 'facility': 'Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"'}, {'zip': 'CP 97000', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Unidad Reumatologica Las Americas S.C.P', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': '11150', 'city': 'Salé', 'country': 'Morocco', 'facility': 'El Ayachi Hospital', 'geoPoint': {'lat': 34.0531, 'lon': -6.79846}}, {'zip': '11150', 'city': 'Salé', 'country': 'Morocco', 'facility': 'Groupe Radiologique de Salé', 'geoPoint': {'lat': 34.0531, 'lon': -6.79846}}, {'zip': '11150', 'city': 'Salé', 'country': 'Morocco', 'facility': "Laboratoire les Arcades d'Analyses Médicales", 'geoPoint': {'lat': 34.0531, 'lon': -6.79846}}, {'zip': 'Lima 29', 'city': 'San Juan de Miraflores', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Hospital María Auxiliadora - Centro de Investigaciones Medicas', 'geoPoint': {'lat': -12.15991, 'lon': -76.96914}}, {'zip': 'Lima 33', 'city': 'Santiago de Surco', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva', 'geoPoint': {'lat': -12.13588, 'lon': -77.00742}}, {'zip': 'CP656', 'city': 'Arequipa', 'country': 'Peru', 'facility': 'Centro de diagnóstico por imágenes, Radiología General y Especial', 'geoPoint': {'lat': -16.39899, 'lon': -71.53747}}, {'zip': 'CP656', 'city': 'Arequipa', 'country': 'Peru', 'facility': 'Unidad de Investigación en Medicina Interna y Enfermedades Críticas', 'geoPoint': {'lat': -16.39899, 'lon': -71.53747}}, {'zip': 'Lima 27', 'city': 'Lima', 'country': 'Peru', 'facility': 'Centro de Investigación Reumatología CAA', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 31', 'city': 'Lima', 'country': 'Peru', 'facility': 'Clinica Medica Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 31', 'city': 'Lima', 'country': 'Peru', 'facility': 'Servicio de Inmunología y Reumatología', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '4217/043', 'city': 'Lipa City', 'state': 'Batangas', 'country': 'Philippines', 'facility': 'Mary Mediatrix Medical Center', 'geoPoint': {'lat': 13.9411, 'lon': 121.1631}}, {'zip': '8000', 'city': 'Davao City', 'state': 'Davao DEL SUR', 'country': 'Philippines', 'facility': 'Southern Philippines Medical Center', 'geoPoint': {'lat': 7.07306, 'lon': 125.61278}}, {'zip': '1229', 'city': 'Makati City', 'state': 'National Capital Region', 'country': 'Philippines', 'facility': 'Makati Medical Center', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Medical Center Manila', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1102', 'city': 'Quezon', 'country': 'Philippines', 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 7.73028, 'lon': 125.09889}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31-121', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '05-830', 'city': 'Nadarzyn', 'country': 'Poland', 'facility': 'NZOZ Lecznica MAK-MED. S.C.', 'geoPoint': {'lat': 52.09438, 'lon': 20.80776}}, {'zip': '67-100', 'city': 'Nowa Sól', 'country': 'Poland', 'facility': 'Twoja Przychodnia - Centrum Medyczne Nowa Sol', 'geoPoint': {'lat': 51.80333, 'lon': 15.71702}}, {'zip': '02-106', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'MTZ Clinical Research Sp. z o.o.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '800578', 'city': 'Galati', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"', 'geoPoint': {'lat': 45.43687, 'lon': 28.05028}}, {'zip': '700656', 'city': 'Iași', 'country': 'Romania', 'facility': 'Spitalul Clinic de Recuperare Iasi', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '540136', 'city': 'Târgu Mureş', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean de Urgenta Targu Mures', 'geoPoint': {'lat': 46.54245, 'lon': 24.55747}}, {'zip': '185019', 'city': 'Petrozavodsk', 'state': 'Republic of Karelia', 'country': 'Russia', 'facility': 'GBUZ "Republican hospital n.a. V.A.Baranov"', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '650000', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '660014', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '660022', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '305007', 'city': 'Kursk', 'country': 'Russia', 'facility': 'GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '129327', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GBUZ of city of Moscow', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '390026', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'GBU of Ryazan region "Regional clinical cardiology dispanser"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '390039', 'city': 'Ryazan', 'country': 'Russia', 'facility': 'GBOU of Ryazan region "Regional clinical hospital"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '190068', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '410053', 'city': 'Saratov', 'country': 'Russia', 'facility': 'GUZ "Regional clinical hospital"', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'zip': '600023', 'city': 'Vladimir', 'country': 'Russia', 'facility': 'GBUZ VO \'Regional clinical hospital"', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '150002', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '11 000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Clinical Hospital Center Bezanijska Kosa', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '11 000', 'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Military Medical Academy', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'zip': '18205', 'city': 'Niška Banja', 'country': 'Serbia', 'facility': 'Institute for Treatment and Rehabilitation "Niska Banja"', 'geoPoint': {'lat': 43.29507, 'lon': 22.0057}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Charlotte Maxeke Johannesburg Academic Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0002', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Jakaranda Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0084', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Emmed Research', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '7405', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Arthritis Clinical Research Unit', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7405', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Vincent Pallotti Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '143-729', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '2010', 'city': 'Manouba', 'country': 'Tunisia', 'facility': 'Mohamed Kassab Institute of orthopedics', 'geoPoint': {'lat': 36.81006, 'lon': 10.09557}}, {'zip': '1007', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'Rabta Hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}, {'zip': '49027', 'city': 'Dnipropetrovsk', 'country': 'Ukraine', 'facility': 'Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut', 'geoPoint': {'lat': 48.46664, 'lon': 35.04066}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '61176', 'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'zip': '29000', 'city': 'Khmelnytskyi', 'country': 'Ukraine', 'facility': 'Khmelnytska oblasna likarnia', 'geoPoint': {'lat': 49.41835, 'lon': 26.97936}}, {'zip': '03680', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Kyivska miska klinichna likarnia #6', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79014', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '50056', 'city': 'M. Kryvyi Rih', 'country': 'Ukraine', 'facility': 'Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"'}, {'zip': '40022', 'city': 'M. Sumy', 'country': 'Ukraine', 'facility': 'Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"'}, {'zip': '21018', 'city': 'M. Vinnytsia', 'country': 'Ukraine', 'facility': 'Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne'}, {'zip': '65025', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Komunalna ustanova "Odeska oblasna klinichna likarnia"', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '65026', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '69600', 'city': 'Zaporizhzhia', 'country': 'Ukraine', 'facility': 'Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady', 'geoPoint': {'lat': 47.15214, 'lon': 35.74246}}, {'zip': 'WN6 9EP', 'city': 'Wigan', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Wrightington Hospital', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}