Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-01 @ 3:06 AM
Study NCT ID:
NCT01070303
Status:
COMPLETED
Last Update Posted:
2011-04-11
First Post:
2010-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Remission in Subjects With Crohn's Disease, Open Label Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (AEs), defined as AEs beginning on or after first dose of adalimumab (in NCT00055523, NCT00055497, or NCT01070303) are reported. Treatment-emergent AEs were recorded up to 70 days after last dose of adalimumab.', 'description': 'Adverse events are reported for all participants who entered the study (NCT00055497), N=276. These 276 participants include the 177 participants who continued into the open-label extension (NCT01070303).', 'eventGroups': [{'id': 'EG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.', 'otherNumAtRisk': 55, 'otherNumAffected': 50, 'seriousNumAtRisk': 55, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.', 'otherNumAtRisk': 221, 'otherNumAffected': 207, 'seriousNumAtRisk': 221, 'seriousNumAffected': 69}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tooth impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Antinuclear antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 43}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 32}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Coronary artery disease', 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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Colonic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastric ulcer', 'stats': 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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Small intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain', 'stats': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Parvovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Retroperitoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Langerhans' cell granulomatosis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 221, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 152', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 212', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 260', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': "A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 .'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in Study to Week 152', 'description': "A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': "CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': "A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.'}, {'type': 'SECONDARY', 'title': 'Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 104.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 152.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 212.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at Week 260.'}, {'type': 'SECONDARY', 'title': 'Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Change From Baseline-Week 104', 'description': 'The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.'}, {'id': 'OG001', 'title': 'Change From Baseline-Week 152', 'description': 'The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.'}, {'id': 'OG002', 'title': 'Change From Baseline-Week 200', 'description': 'The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.'}, {'id': 'OG003', 'title': 'Change From Baseline-Week 248', 'description': 'The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '36.27', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '33.70', 'groupId': 'OG001'}, {'value': '51.0', 'spread': '32.77', 'groupId': 'OG002'}, {'value': '51.7', 'spread': '32.67', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248', 'description': 'IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 104.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'OG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants in Open-Label Extension of Study M02-433', 'description': 'Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Administrative Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Participants who were still receiving study drug and were evaluated at Week 56 of Study M02-433 (NCT00055497) are included in the open-label extension (OLE) (NCT01070303). Participants entered NCT00055497 from a lead-in adalimumab induction therapy study (NCT00055523).', 'preAssignmentDetails': 'Clinical remission = CDAI \\<150. At Week 4 of NCT00055497, "remitters" (participants in clinical remission at Week 0 and Week 4 of NCT00055497) were randomized to double blind (DB) therapy and "non-remitters" (participants not in clinical remission at Week 0 or no longer in clinical remission at Week 4) were assigned to open-label (OL) adalimumab.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \\< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.'}, {'id': 'BG001', 'title': 'Non-Remitters', 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '12.53', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '12.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2010-02-16', 'resultsFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-02-16', 'lastUpdatePostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-19', 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).", 'timeFrame': 'Week 104', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).', 'timeFrame': 'Week 152', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).', 'timeFrame': 'Week 212', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).', 'timeFrame': 'Week 260', 'description': "Clinical remission is defined as CDAI score \\<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': "A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)', 'timeFrame': 'Week 104', 'description': "A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in Study to Week 152', 'description': "A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': "CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': "A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \\>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity."}, {'measure': 'Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.'}, {'measure': 'Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.'}, {'measure': 'Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.'}, {'measure': 'Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score \\< 150 points at that visit.'}, {'measure': 'Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.'}, {'measure': 'Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.'}, {'measure': 'Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.'}, {'measure': 'Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': 'Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.'}, {'measure': 'Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores', 'timeFrame': 'Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248', 'description': 'IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.'}, {'measure': 'Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 104', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.'}, {'measure': 'Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 152', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.'}, {'measure': 'Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 212', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.'}, {'measure': 'Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)', 'timeFrame': 'From Baseline of lead-in study to Week 260', 'description': 'A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HUMIRA', 'adalimumab', 'Inflammatory Bowel Disease'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '29380251', 'type': 'DERIVED', 'citation': 'Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.'}]}, 'descriptionModule': {'briefSummary': "The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.", 'detailedDescription': 'Study M02-433 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohn\'s disease (CD). The study consisted of 2 phases: 1. a 1-year phase (Week 0 to Week 56) (NCT00055497) that consisted of a randomized, double-blind, placebo-controlled portion with a concomitant open label (OL) portion, and 2. a long-term open-label extension (OLE) phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).\n\nParticipants who completed the lead-in study NCT00055523, were eligible to participate in the rollover study, NCT00055497. 176 participants were documented as having completed Year 1 (NCT00055497); however, 177 participants were still receiving study drug and were evaluated at Week 56 of NCT00055497; these participants are included in the OLE data (NCT01070303).\n\nAt Week 4 of NCT00055497, participants who demonstrated clinical remission (defined as a Crohn\'s Disease Activity Index \\[CDAI\\] score \\<150 points) at Baseline of NCT00055497 and who remained in clinical remission at Week 4 ("Remitters") were randomized to receive 1 of 3 blinded treatments: placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg every week (ew). Participants who did not demonstrate clinical remission at Baseline of NCT00055497 or who were no longer in clinical remission at Week 4 of NCT00055497 ("Non-remitters") were assigned to receive OL adalimumab 40 mg eow. All study drug (placebo and active) was administered by subcutaneous (SC) injection.\n\nAt any time during Study NCT00055497, a participant receiving blinded study drug who developed a disease flare could be switched to OL adalimumab 40 mg eow. A participant receiving OL adalimumab 40 mg SC eow who developed a flare or was a non-responders could have had his/her dose increased to 40 mg SC ew.\n\nAfter 1 year (Week 56 of NCT00055497), patients who were still participating could continue in the OLE phase (NCT01070303). Participants who were receiving blinded study drug were switched to OL adalimumab 40 mg SC eow, and participants who were receiving OL study drug continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or ew).\n\nData are summarized for Remitters and Non-remitters, with the exception of data for primary reason for noncompletion. Summaries of primary reason for noncompletion were available only for all participants, not for Remitters and Non-remitters. Data are reported for Weeks 104, 152, 212, and 260 of Study M02-433, starting from Week 0 of NCT00055497; these weeks correspond to 1, 2, 3, and 4 years of participation in NCT01070303. Change from Baseline results (clinical response 70, clinical response 100, Inflammatory Bowel Disease Questionnaire, and fistula remission) are calculated from Baseline of the lead-in study (NCT00055523). Results on each assessment at each measurement time point are presented as individual outcome measures because different numbers of participants were evaluated at each time point (as observed analysis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant had completed the Year 1 of Study M02-433 (NCT00055497)\n* Diagnosis of Crohn's disease\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* Diagnosis of ulcerative colitis\n* Pregnancy or breastfeeding\n* Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists\n* Previous history of active tuberculosis or listeria infection\n* Previous history of cancer other than successfully treated skin cancer"}, 'identificationModule': {'nctId': 'NCT01070303', 'acronym': 'CLASSICII', 'briefTitle': "Remission in Subjects With Crohn's Disease, Open Label Extension", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension", 'orgStudyIdInfo': {'id': 'M02-433 Open Label'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adalimumab 40 mg every other week or every week', 'interventionNames': ['Biological: Adalimumab 40 mg eow or ew']}], 'interventions': [{'name': 'Adalimumab 40 mg eow or ew', 'type': 'BIOLOGICAL', 'otherNames': ['Adalimumab', 'Humira'], 'description': 'Adalimumab 40 mg by subcutaneous injection every other week or every week', 'armGroupLabels': ['Adalimumab 40 mg every other week or every week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Gastroenterology Associates of the East Bay', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Gastroenterology Assoc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rees-Stealy Medical Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Gastroenterology Assoc. of Fairfield Co.', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Shafran Gastroenterology Center', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Gastroenterology Assoc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeastern Digestive & Liver Disease', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Gastroenterologists, S.C.', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Drug Research Services, Inc.', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Digestive Disorders Associates', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01610', 'city': 'Worchester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Pharmacology Study Group'}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic and Mayo Foundation', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Gastroenterology and Hepatology', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '65265', 'city': 'Mexico', 'state': 'Missouri', 'country': 'United States', 'facility': 'Glenn Gordon, MD', 'geoPoint': {'lat': 39.16976, 'lon': -91.88295}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Deaconess Billings Clinic Research Division', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '68503', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Gastroenterology Specialties, P.C.', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Clinical Research Associates', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'NY Center for Clinical Research', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Daniel Present', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14607', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Institute for Digestive Diseases', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Gastroenterology and Hepatology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28262', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Research Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Digestive Health Specialists', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Consultants for Clinical Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Disease', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Solutions', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Peter Molloy, MD', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Diseases of the Digestive System', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nashville Medical Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Charlottesville Medical Research', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Gastroenterology', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Inland Empire Gastroenterology', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Tacoma Digestive Disease Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53207', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Wisconsin Center for Advanced Research', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Anne Camez, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anne Camez, Medical Director', 'oldOrganization': 'Abbott'}}}}