Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-07 @ 4:45 AM
Study NCT ID:
NCT00264550
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2005-12-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'India', 'Turkey (Türkiye)']}, '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': 'C529000', 'term': 'golimumab'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-457-6399', 'title': 'Director Clinical Research', 'organization': 'Centocor Research & Development, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in \\<= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 5 years', 'description': 'All patients randomized to the "Placebo + Methorexate" arm at baseline received golimumab at Week 16 (early escape) or Week 24 (cross over). 5-year safety data are presented according to the dose of golimumab received during the study. 10 patients did not receive any treatment with golimumab and are not included in the 5-year safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Golimumab 50 mg SC Injections Only', 'description': 'Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.', 'otherNumAtRisk': 105, 'otherNumAffected': 96, 'seriousNumAtRisk': 105, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Group 2: Golimumab 100 mg SC Injections Only', 'description': 'Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.', 'otherNumAtRisk': 184, 'otherNumAffected': 160, 'seriousNumAtRisk': 184, 'seriousNumAffected': 84}, {'id': 'EG002', 'title': 'Group 3: Golimumab 50 and 100 mg SC Injections', 'description': 'Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.', 'otherNumAtRisk': 145, 'otherNumAffected': 118, 'seriousNumAtRisk': 145, 'seriousNumAffected': 55}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Fungal Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Upper Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Skin Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cardiovascular Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Congestive Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cyanosis', 'stats': 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Lung Adenocarcinoma Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Lymphoma', 'stats': 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malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Prostate Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Thyroid Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Axonal Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Lumbar Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Calculus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nephrotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Stress Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Breast Calcifications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Breast Enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Dysfunctional Uterine Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Menopausal Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pelvic Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Uterine Prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Lung Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Nasal Septum Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Obstructive Airways Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Vocal Cord Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Vocal Cord Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Hypertensive Emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}, {'term': 'Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 184, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 145, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG004', 'title': 'Combined Golimumab + Methotrexate', 'description': 'Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '99', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'pValueComment': 'The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.', 'groupDescription': 'Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \\>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \\& IV).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide \\>90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III \\& IV).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.', 'groupDescription': 'Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I \\& II provides \\>85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': "ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to each treatment group'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG004', 'title': 'Combined Golimumab + Methotrexate', 'description': 'Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '131', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': "DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of \\<= 3.2 (good response) or \\> 3.2 to 5.1 (moderate response).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to each treatment group'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG004', 'title': 'Combined Golimumab + Methotrexate', 'description': 'Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1250', 'groupId': 'OG000', 'lowerLimit': '-0.1250', 'upperLimit': '0.3750'}, {'value': '0.1250', 'groupId': 'OG001', 'lowerLimit': '-0.2500', 'upperLimit': '0.6250'}, {'value': '0.3750', 'groupId': 'OG002', 'lowerLimit': '0.1250', 'upperLimit': '0.7500'}, {'value': '0.5000', 'groupId': 'OG003', 'lowerLimit': '0.1250', 'upperLimit': '0.7500'}, {'value': '0.4375', 'groupId': 'OG004', 'lowerLimit': '0.1250', 'upperLimit': '0.7500'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'pValueComment': 'The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.', 'groupDescription': 'Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.', 'statisticalMethod': 'ANOVA on van der Waerden normal scores.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.', 'statisticalMethod': 'ANOVA on van der Waerden normal scores.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.', 'statisticalMethod': 'ANOVA on van der Waerden normal scores.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.240', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.', 'statisticalMethod': 'ANOVA on van der Waerden normal scores.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': 'HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to each treatment group'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG004', 'title': 'Combined Golimumab + Methotrexate', 'description': 'Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '106', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.187', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to each treatment group'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG004', 'title': 'Combined Golimumab + Methotrexate', 'description': 'Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1250', 'groupId': 'OG000', 'lowerLimit': '-0.1250', 'upperLimit': '0.3750'}, {'value': '0.2500', 'groupId': 'OG001', 'lowerLimit': '-0.1250', 'upperLimit': '0.6250'}, {'value': '0.3750', 'groupId': 'OG002', 'lowerLimit': '0.1250', 'upperLimit': '0.7500'}, {'value': '0.3750', 'groupId': 'OG003', 'lowerLimit': '0.1250', 'upperLimit': '0.6250'}, {'value': '0.3750', 'groupId': 'OG004', 'lowerLimit': '0.1250', 'upperLimit': '0.7500'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA on van der Waerden noramal', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0) and Week 14', 'description': 'The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to each treatment group'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '89', 'groupId': 'OG003'}, {'value': '178', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'OG004', 'title': 'Combined Golimumab + Methotrexate', 'description': 'Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '2.354', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.00', 'spread': '1.598', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.00', 'spread': '2.740', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.00', 'spread': '1.342', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.00', 'spread': '2.159', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.50'}]}]}], 'analyses': [{'pValue': '0.551', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANOVA on van der Waerden normal', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.953', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.293', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANOVA on van der waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.361', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA on van der Waerden normal scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': 'The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomly assigned to each treatment group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'FG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'FG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'FG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}, {'groupId': 'FG001', 'numSubjects': '133'}, {'groupId': 'FG002', 'numSubjects': '89'}, {'groupId': 'FG003', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Discontinued oral study agent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'A total of 444 participants were enrolled at 60 sites in 12 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '444', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'BG001', 'title': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'BG002', 'title': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'BG003', 'title': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '11.96', 'groupId': 'BG000'}, {'value': '50', 'spread': '11.47', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '10.98', 'groupId': 'BG002'}, {'value': '50', 'spread': '10.78', 'groupId': 'BG003'}, {'value': '50.4', 'spread': '11.36', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '358', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2005-12-11', 'resultsFirstSubmitDate': '2009-05-21', 'studyFirstSubmitQcDate': '2005-12-11', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-04', 'studyFirstPostDateStruct': {'date': '2005-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 14', 'timeFrame': 'Week 14', 'description': "ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain of pain by the Visual Analogue Scale (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity VAS (0-10 cm) c. Physician's Global Assessment of Disease Activity VAS (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 24', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': 'HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Disease Activity Index Score 28 (DAS 28) Using C-reactive Protein (CRP) Response at Week 14', 'timeFrame': 'Week 14', 'description': "DAS 28 using CRP is an index to measure the disease activity in participants with rheumatoid arthritis which combines tender joint count (28 joints), swollen joint count (28 joints), CRP value, and participant's global assessment of disease activity (using a Visual Analog Scale of 0 to 100 mm). The DAS 28 score ranges from 0 (best) to 10 (worst). Participants are considered to have a DAS 28 response if they have a score of \\<= 3.2 (good response) or \\> 3.2 to 5.1 (moderate response)."}, {'measure': 'Number of Participants Who Achieved American College of Rheumatology 20 (ACR 20) Response at Week 24', 'timeFrame': 'Week 24', 'description': "An ACR 20 response is defined as a greater than or equal to 20 percent improvement from baseline in: 1. Swollen joint count (66 joints) and tender joint count (68 joints) 2. greater than or equal to 50 percentage improvement in 3 of the following 5 assessments: a. Patient's assessment of pain (VAS) (0-10 cm) b.Patient's Global Assessment of Disease activity (VAS) (0-10 cm) c. Physician's Global Assessment of Disease Activity (VAS) (0-10 cm) d. Patient's assessment of physical function as measured by the Health Assessment Questionnaire (HAQ) e. C reactive protein (CRP)."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Week 14', 'timeFrame': 'Baseline (Week 0) and Week 14', 'description': 'The HAQ is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0 (no difficulty), to 3 (inability to perform a task in that area). The average score across the functional areas yields an overall HAQ score which ranges from 0 (no disability) to 3 (completely disabled).'}, {'measure': 'Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 24', 'timeFrame': 'Baseline (Week 0) and Week 24', 'description': 'The vdH-S score is the sum of joint erosion score and joint-space narrowing (JSN) score. The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Golimumab', 'Methotrexate', 'Fully Human anti-TNFa monoclonal antibody', 'Simpony'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '30412238', 'type': 'DERIVED', 'citation': 'Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.'}, {'pmid': '28606966', 'type': 'DERIVED', 'citation': 'George MD, Ostergaard M, Conaghan PG, Emery P, Baker DG, Baker JF. Obesity and rates of clinical remission and low MRI inflammation in rheumatoid arthritis. Ann Rheum Dis. 2017 Oct;76(10):1743-1746. doi: 10.1136/annrheumdis-2017-211569. Epub 2017 Jun 12.'}, {'pmid': '27803138', 'type': 'DERIVED', 'citation': 'Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. doi: 10.3899/jrheum.160420. Epub 2016 Nov 1.'}, {'pmid': '27696724', 'type': 'DERIVED', 'citation': 'Mack ME, Hsia E, Aletaha D. Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points. Arthritis Rheumatol. 2017 Mar;69(3):518-528. doi: 10.1002/art.39945.'}, {'pmid': '24757132', 'type': 'DERIVED', 'citation': 'Baker JF, Conaghan PG, Smolen JS, Aletaha D, Shults J, Emery P, Baker DG, Ostergaard M. Development and validation of modified disease activity scores in rheumatoid arthritis: superior correlation with magnetic resonance imaging-detected synovitis and radiographic progression. Arthritis Rheumatol. 2014 Apr;66(4):794-802. doi: 10.1002/art.38304.'}, {'pmid': '23678153', 'type': 'DERIVED', 'citation': 'Keystone EC, Genovese MC, Hall S, Miranda PC, Bae SC, Palmer W, Wu Z, Xu S, Hsia EC. Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: results through 2 years of the GO-FORWARD study extension. J Rheumatol. 2013 Jul;40(7):1097-103. doi: 10.3899/jrheum.120584. Epub 2013 May 15.'}, {'pmid': '22505702', 'type': 'DERIVED', 'citation': 'Genovese MC, Han C, Keystone EC, Hsia EC, Buchanan J, Gathany T, Murphy FT, Wu Z, Parasuraman S, Rahman MU. Effect of golimumab on patient-reported outcomes in rheumatoid arthritis: results from the GO-FORWARD study. J Rheumatol. 2012 Jun;39(6):1185-91. doi: 10.3899/jrheum.111195. Epub 2012 Apr 15.'}, {'pmid': '21083889', 'type': 'DERIVED', 'citation': 'Visvanathan S, Rahman MU, Keystone E, Genovese M, Klareskog L, Hsia E, Mack M, Buchanan J, Elashoff M, Wagner C. Association of serum markers with improvement in clinical response measures after treatment with golimumab in patients with active rheumatoid arthritis despite receiving methotrexate: results from the GO-FORWARD study. Arthritis Res Ther. 2010;12(6):R211. doi: 10.1186/ar3188. Epub 2010 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate (MTX), as compared to methotrexate alone in rheumatoid arthritis (RA) patients who have active rheumatoid arthritis despite treatment with MTX.', 'detailedDescription': 'This is a randomized (treatment is assigned by chance), double-blind (neither the physician nor the patient is aware of the received treatment), placebo-controlled study of multiple subcutaneous (SC) administrations of golimumab at 2 doses as monotherapy or in combination with MTX in patients with active RA despite treatment with MTX. The duration of participation in the study for an individual patient will be upto 268 weeks. The patients will be randomly assigned in a 3:3:2:2 ratio to receive golimumab 50 mg or 100 mg or placebo injections under the skin every 4 weeks through week 20 and methotrexate or placebo capsules will be given in addition. At Week 24, all subjects will receive golimumab 50mg or 100mg injections, and golimumab continues for all groups for about 4 and a half more years. At Week 16 any patient in the study who meets criteria for \\< 20% improvement from baseline in both swollen and tender joint count will enter early escape in a double-blinded fashion. Treatment during the long-term extension will start at Week 52 and continue every 4 weeks thereafter for a total of approximately 5 years from the initial (Week 0) administration of study agent. Patients will return for scheduled follow-up visits generally every 12 weeks for a total length of follow-up of approximately 5 years from the first administration of the study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to screening\n* Must have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of \\>=15 mg/week and \\<=25 mg/week and stable for at least 4 weeks prior to screening\n* Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a)C-reactive protein (CRP) \\>=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of \\>= 28 mm in the first hour at screening or baseline, b)Morning stiffness of \\>= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or magnetic resonance imaging (MRI) prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening\n* If using oral corticosteroids, must be on a stable dose equivalent to \\<= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent\n* Are considered eligible according to specified tuberculosis (TB) screening criteria\n\nExclusion Criteria:\n\n* Have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy\n* Have had treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives other than MTX, during the 4 weeks prior to the first administration of study agent\n* Have had prior treatment with biologic anti-tumor necrosis factor (TNF) drugs (infliximab, etanercept, adalimumab)\n* Have had history of, or ongoing, chronic or recurrent infectious disease.\n* Have serious infection within 2 months prior to first administration of study agent\n* Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening'}, 'identificationModule': {'nctId': 'NCT00264550', 'acronym': 'GO-FORWARD', 'briefTitle': 'An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy', 'orgStudyIdInfo': {'id': 'CR006343'}, 'secondaryIdInfos': [{'id': 'C0524T06', 'type': 'OTHER', 'domain': 'Centocor'}, {'id': '2004-003296-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1: Placebo + Methotrexate', 'description': "Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.", 'interventionNames': ['Drug: Methotrexate', 'Drug: Placebo injection']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Golimumab 100 mg + Placebo', 'description': "Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7-10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.", 'interventionNames': ['Drug: Golimumab 100 mg', 'Drug: Placebo capsules']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Golimumab 50 mg + Methotrexate', 'description': "Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.", 'interventionNames': ['Drug: Golimumab 50 mg', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Golimumab 100 mg + Methotrexate', 'description': "Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period will be until the week-52 database lock.", 'interventionNames': ['Drug: Golimumab 100 mg', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Golimumab 100 mg', 'type': 'DRUG', 'description': 'Participants will receive subcutaneous (SC) injections of golimumab 100 mg every 4 weeks.', 'armGroupLabels': ['Group 2: Golimumab 100 mg + Placebo', 'Group 4: Golimumab 100 mg + Methotrexate']}, {'name': 'Golimumab 50 mg', 'type': 'DRUG', 'description': 'Participants will receive subcutaneous (SC) injections of golimumab 50 mg every 4 weeks.', 'armGroupLabels': ['Group 3: Golimumab 50 mg + Methotrexate']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Participants will receive methotrexate capsules weekly.', 'armGroupLabels': ['Group 1: Placebo + Methotrexate', 'Group 3: Golimumab 50 mg + Methotrexate', 'Group 4: Golimumab 100 mg + Methotrexate']}, {'name': 'Placebo injection', 'type': 'DRUG', 'description': 'Participants will receive subcutaneous (SC) injections of placebo every 4 weeks.', 'armGroupLabels': ['Group 1: Placebo + Methotrexate']}, {'name': 'Placebo capsules', 'type': 'DRUG', 'description': 'Participants will receive placebo capsules weekly', 'armGroupLabels': ['Group 2: Golimumab 100 mg + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Upland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 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