Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03532932
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months after enrollment into the study', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.', 'otherNumAtRisk': 1214, 'deathsNumAtRisk': 1214, 'otherNumAffected': 48, 'seriousNumAtRisk': 1214, 'deathsNumAffected': 3, 'seriousNumAffected': 146}, {'id': 'EG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.', 'otherNumAtRisk': 687, 'deathsNumAtRisk': 687, 'otherNumAffected': 31, 'seriousNumAtRisk': 687, 'deathsNumAffected': 5, 'seriousNumAffected': 84}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Gilbert's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug resistance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of therapeutic response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatocellular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Bartholin's abscess", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cell death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sacroiliitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical leukoplakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of therapeutic response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alopecia totalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Yellow skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Intestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abscess intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cervical leukoplakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ileal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Enterocolonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Large intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyelonephritis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Small intestinal resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ileectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': "Takayasu's arteritis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Greater than (>) 5-aminosalicylic acid (5ASA) 1', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '>5ASA 2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '> 5ASA 3', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': '>5ASA 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>5ASA 5', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '>5ASA 6', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '>5ASA 7', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>BIO 1', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '>BIO 2', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': '>BIO 3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': '>BIO 4', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': '>Immunosuppressive (IS) 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '>IS 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '>IS 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '>IS 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '>IS 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>IS 6', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '>IS 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 5', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 6', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '>IS+5ASA 7', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '>No IBD Therapy (NO TR) 1', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': '>NO TR 2', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': '>NO TR 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>Steroids (STER) 1', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': '>STER 2', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': '>STER 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '>STER 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '>STER 5', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Pattern with combination of biologics (BIO COMB)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Vedolizumab', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': 'Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \\[SB\\] +/- STER+/-standard therapy\\[ST\\]),\\>5ASA2(without \\[w/o\\] STER),\\>5ASA3(5-ASA→STER+/-ST),\\>5ASA4(5-ASA→IS),\\>5ASA 5(5-ASA→5-ASA+/-IS),\\>5ASA6(5-ASA→ NOTR),\\>5ASA7(5-ASA),\\>NOTR1(NOTR→Biologics \\[BIO\\]+/-ST+/-STER),\\>NOTR 2(TR→ST+/-STER),\\>NOTR 3(NOTR),\\>IS1(IS→SB+STER+/-ST),\\>IS2(IS→SB+ST w/o STER),\\>IS 3(IS→STER+/-ST),\\>IS4(IS→5-ASA),\\>IS5(IS→NOTR),\\>IS6(IS→5-ASA+IS),\\>IS7(IS mono),\\>IS+5ASA1(IS+5-ASA→SB +/-ST),\\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\\>IS+5ASA3(IS+5-ASA→STER+/-ST),\\>IS+5ASA4(IS+5-ASA→NOTR),\\>IS+5ASA5(IS+5-ASA→IS),\\>IS+5ASA6(IS+5-ASA→5-ASA),\\>IS+5ASA7(IS+5-ASA),\\>BIO1(SB+/-STER+/-ST→withdrawal \\[w/d\\] of SB+ST+/-STER),\\>BIO2(SB+/-STER+/-ST),\\>BIO3(SB+/-STER+/-ST→NOTR),\\>BIO4(SB+/-STER+/-ST→SB mono),\\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\\>STER2(STER+/-ST→w/d of STER+ST),\\>STER3(STER+/-ST→SB+STER+/-ST),\\>STER4(STER+/-ST→NOTR),\\>STER5(STER+/-ST).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Stratified by Location of Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Lining of the Rectum', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left Side of Colon', 'categories': [{'measurements': [{'value': '623', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ileum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Colon', 'categories': [{'measurements': [{'value': '750', 'groupId': 'OG000'}, {'value': '183', 'groupId': 'OG001'}]}]}, {'title': 'Ileum and Colon', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}]}, {'title': 'Upper Gastrointestinal Tract', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 1 year prior to Baseline (Visit 1)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Stratified by Disease Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Visit 1: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}]}]}, {'title': 'Visit 1: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '406', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}, {'title': 'Visit 1: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '522', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Visit 1: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1153', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '576', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '984', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3: Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '614', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '945', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period', 'description': "Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (\\<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score \\>16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score \\<2 was remission, score 3-5 was mild, score 6-10 was moderate, and score \\>10 was severe.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified visits.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Biomarkers', 'categories': [{'measurements': [{'value': '1151', 'groupId': 'OG000'}, {'value': '662', 'groupId': 'OG001'}]}]}, {'title': 'Endoscopy', 'categories': [{'measurements': [{'value': '1188', 'groupId': 'OG000'}, {'value': '656', 'groupId': 'OG001'}]}]}, {'title': 'Biopsy', 'categories': [{'measurements': [{'value': '901', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}]}, {'title': 'X-ray Examination', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}, {'title': 'MRI Examination', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}]}, {'title': 'Ultrasound Examination', 'categories': [{'measurements': [{'value': '283', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline Visit (Day 1) up to 12 months', 'description': 'Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Biomarkers', 'categories': [{'measurements': [{'value': '4.52', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '6.74', 'spread': '7.11', 'groupId': 'OG001'}]}]}, {'title': 'Endoscopy', 'categories': [{'measurements': [{'value': '2.60', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '1.39', 'groupId': 'OG001'}]}]}, {'title': 'Biopsy', 'categories': [{'measurements': [{'value': '1.38', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'X-ray Examination', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '1.13', 'groupId': 'OG001'}]}]}, {'title': 'MRI Examination', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Ultrasound Examination', 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline Visit (Day 1) up to 12 months', 'description': "Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation.", 'unitOfMeasure': 'assessments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Visit 1: Remission', 'categories': [{'measurements': [{'value': '18.30', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1: Mild Activity', 'categories': [{'measurements': [{'value': '35.21', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1: Moderate Activity', 'categories': [{'measurements': [{'value': '45.27', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1: Severe Activity', 'categories': [{'measurements': [{'value': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Remission', 'categories': [{'measurements': [{'value': '58.54', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Mild Activity', 'categories': [{'measurements': [{'value': '30.49', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Moderate Activity', 'categories': [{'measurements': [{'value': '10.67', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Severe Activity', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Remission', 'categories': [{'measurements': [{'value': '64.97', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Mild Activity', 'categories': [{'measurements': [{'value': '26.46', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Moderate Activity', 'categories': [{'measurements': [{'value': '8.57', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Severe Activity', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period', 'description': "The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score \\<2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score \\>10 was severe activity. Higher scores indicating higher disease activity.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Visit 1: Remission', 'categories': [{'measurements': [{'value': '50.31', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1: Mild Activity', 'categories': [{'measurements': [{'value': '25.94', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1: Moderate Activity', 'categories': [{'measurements': [{'value': '22.50', 'groupId': 'OG000'}]}]}, {'title': 'Visit 1: Severe Activity', 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Remission', 'categories': [{'measurements': [{'value': '67.53', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Mild Activity', 'categories': [{'measurements': [{'value': '23.71', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Moderate Activity', 'categories': [{'measurements': [{'value': '8.57', 'groupId': 'OG000'}]}]}, {'title': 'Visit 2: Severe Activity', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Remission', 'categories': [{'measurements': [{'value': '72.20', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Mild Activity', 'categories': [{'measurements': [{'value': '20.60', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Moderate Activity', 'categories': [{'measurements': [{'value': '6.80', 'groupId': 'OG000'}]}]}, {'title': 'Visit 3: Severe Activity', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period', 'description': 'HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score \\<5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score \\>16 was severe activity. Higher scores indicating higher disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1203', 'groupId': 'OG000'}, {'value': '670', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'If an Exacerbation or Deterioration Developed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '15.0'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '21.0'}]}]}, {'title': 'Every 3 months, as well as in the Development of Exacerbation or Deterioration', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '19.2'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '22.0'}]}]}, {'title': 'Every six months, as well as When the Exacerbation or Deterioration', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '21.4'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '22.4'}]}]}, {'title': 'Once a year, as well as in the Case of the Development of Exacerbation or Deteriorations', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '23.7'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '24.4'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Stratified by Achieving the Treatment Goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}, {'value': '70.3', 'groupId': 'OG001'}]}]}, {'title': 'Endoscopic Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}]}]}, {'title': 'Histological Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000'}, {'value': '27.4', 'groupId': 'OG001'}]}]}, {'title': 'Biomarker Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000'}, {'value': '68.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': 'Treat to target (T2T) approach was used for assessment of treatment goals. A "Treat to target" approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein \\[CRP\\] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Difficulties or Inaccessibility of Colonoscopy', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}, {'title': 'Unwillingness to Undergo Colonoscopy', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '45.7', 'groupId': 'OG001'}]}]}, {'title': "Participant's Failure to Follow Visit Scheduled With Physician", 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}, {'title': "Participant's Non-compliance With Drug Therapy", 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}]}]}, {'title': 'Resistant Course of Disease', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}]}]}, {'title': 'Difficulties or Unavailability of Certain Drugs', 'categories': [{'measurements': [{'value': '65.7', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}]}]}, {'title': 'Workload of Doctor', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Lack of Participants Record System and Monitoring', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': '"Other" challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Hospitalizations due to Complications', 'categories': [{'measurements': [{'value': '2.14', 'groupId': 'OG000'}, {'value': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'IBD Related Surgeries', 'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000'}, {'value': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'IBD Related Disability', 'categories': [{'measurements': [{'value': '29.57', 'groupId': 'OG000'}, {'value': '47.74', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'OG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'classes': [{'title': 'Surgical Treatment by Indication: Aggravation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000'}, {'value': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Intestinal Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'groupId': 'OG000'}]}]}, {'title': 'Surgical Treatment by Indication: Colon Perforation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000'}, {'value': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000'}, {'value': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Internal Fistulas', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Abdominal Cavity Infiltrate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Interintestinal or Intraabdominal Abscess', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Strictures in the gastrointestinal tract', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Treatment by Indication: Anal Fissures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Type of Surgeries: Emergency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000'}, {'value': '0.29', 'groupId': 'OG001'}]}]}, {'title': 'Type of Surgeries: Planned', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': 'Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included those participants who signed the informed consent form and were analyzed in the study. Here, number analyzed signifies participants who were evaluable for given categories.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'FG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1214'}, {'groupId': 'FG001', 'numSubjects': '687'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1140'}, {'groupId': 'FG001', 'numSubjects': '615'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Appearance of Exclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Participants took part in the study at the 36 investigative sites in Russia, Belarus and Kazakhstan from 20 July 2018 to 08 November 2021.', 'preAssignmentDetails': "Participants diagnosed with moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD) were observed retrospectively within 2 years before enrollment and prospectively one year after enrollment. A total of 1990 participants were enrolled (signed informed consent) into the study, of which 89 were screen failures. 1901 participants started the study and were analyzed in the study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1214', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '1901', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'UC Participants', 'description': 'Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'BG001', 'title': 'CD Participants', 'description': 'Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.44', 'spread': '13.63', 'groupId': 'BG000'}, {'value': '36.44', 'spread': '13.90', 'groupId': 'BG001'}, {'value': '39.63', 'spread': '13.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '582', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '923', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '632', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '978', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Russian', 'categories': [{'measurements': [{'value': '858', 'groupId': 'BG000'}, {'value': '574', 'groupId': 'BG001'}, {'value': '1432', 'groupId': 'BG002'}]}]}, {'title': 'Tartarian', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Ukrainian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Baskirian', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Chuvash', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Belarusian', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Kazakh', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belarus', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Kazakhstan', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '1063', 'groupId': 'BG000'}, {'value': '643', 'groupId': 'BG001'}, {'value': '1706', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'title': 'Employed', 'categories': [{'measurements': [{'value': '702', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '1045', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '287', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '476', 'groupId': 'BG002'}]}]}, {'title': 'Pensioner', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}, {'title': 'Student', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disability', 'classes': [{'title': 'Had Disability', 'categories': [{'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '341', 'groupId': 'BG001'}, {'value': '733', 'groupId': 'BG002'}]}]}, {'title': 'Had no Disability', 'categories': [{'measurements': [{'value': '822', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '1168', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Disability was determined based on participant's healthcare resources utilization.", 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Non-smoker and Never Smoked Before', 'categories': [{'measurements': [{'value': '937', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '1456', 'groupId': 'BG002'}]}]}, {'title': 'Ex-smoker', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}]}, {'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age at Disease Onset', 'classes': [{'categories': [{'measurements': [{'value': '34.46', 'spread': '13.17', 'groupId': 'BG000'}, {'value': '30.79', 'spread': '13.57', 'groupId': 'BG001'}, {'value': '33.14', 'spread': '13.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Family History of Inflammatory Bowel Disease (IBD)', 'classes': [{'title': 'With IBD History', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Without IBD History', 'categories': [{'measurements': [{'value': '1180', 'groupId': 'BG000'}, {'value': '666', 'groupId': 'BG001'}, {'value': '1846', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by the following categories: with IBD history and without IBD history.', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Course of IBD', 'classes': [{'title': 'Acute Form (Less than 6 months Since the Onset of the Illness)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Continuous Form (Absence of Remission Longer Than 6 months Despite Adequate Treatment)', 'categories': [{'measurements': [{'value': '362', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Relapsing Course (With Remission Periods Longer Than 6 months)', 'categories': [{'measurements': [{'value': '839', 'groupId': 'BG000'}, {'value': '385', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Complications of IBD', 'classes': [{'title': 'Had Complications of IBD', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}]}]}, {'title': 'Had no Complications of IBD', 'categories': [{'measurements': [{'value': '1103', 'groupId': 'BG000'}, {'value': '370', 'groupId': 'BG001'}, {'value': '1473', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Extraintestinal Manifestation (EIM)', 'classes': [{'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '524', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Extraintestinal manifestation means when disease impacts other part of body. Between 25-40 percent (%) of IBD participants experience EIMs, commonly in the joints, skin, bones, eyes, kidneys, and liver.', 'unitOfMeasure': 'Participants'}, {'title': 'Had Medical History', 'classes': [{'categories': [{'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '452', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) included those participants who signed the informed consent form and were analyzed in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-28', 'size': 6102300, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-27T18:15', 'hasProtocol': True}, {'date': '2021-12-30', 'size': 20947076, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-27T18:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1990}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2018-05-01', 'resultsFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-29', 'studyFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': 'Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like\\>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics \\[SB\\] +/- STER+/-standard therapy\\[ST\\]),\\>5ASA2(without \\[w/o\\] STER),\\>5ASA3(5-ASA→STER+/-ST),\\>5ASA4(5-ASA→IS),\\>5ASA 5(5-ASA→5-ASA+/-IS),\\>5ASA6(5-ASA→ NOTR),\\>5ASA7(5-ASA),\\>NOTR1(NOTR→Biologics \\[BIO\\]+/-ST+/-STER),\\>NOTR 2(TR→ST+/-STER),\\>NOTR 3(NOTR),\\>IS1(IS→SB+STER+/-ST),\\>IS2(IS→SB+ST w/o STER),\\>IS 3(IS→STER+/-ST),\\>IS4(IS→5-ASA),\\>IS5(IS→NOTR),\\>IS6(IS→5-ASA+IS),\\>IS7(IS mono),\\>IS+5ASA1(IS+5-ASA→SB +/-ST),\\>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),\\>IS+5ASA3(IS+5-ASA→STER+/-ST),\\>IS+5ASA4(IS+5-ASA→NOTR),\\>IS+5ASA5(IS+5-ASA→IS),\\>IS+5ASA6(IS+5-ASA→5-ASA),\\>IS+5ASA7(IS+5-ASA),\\>BIO1(SB+/-STER+/-ST→withdrawal \\[w/d\\] of SB+ST+/-STER),\\>BIO2(SB+/-STER+/-ST),\\>BIO3(SB+/-STER+/-ST→NOTR),\\>BIO4(SB+/-STER+/-ST→SB mono),\\>STER1(STER+/-ST→w/d of STER+SB+/-ST),\\>STER2(STER+/-ST→w/d of STER+ST),\\>STER3(STER+/-ST→SB+STER+/-ST),\\>STER4(STER+/-ST→NOTR),\\>STER5(STER+/-ST).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Stratified by Location of Disease', 'timeFrame': 'Within 1 year prior to Baseline (Visit 1)'}, {'measure': 'Number of Participants Stratified by Disease Severity', 'timeFrame': 'At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period', 'description': "Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (\\<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score \\>16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score \\<2 was remission, score 3-5 was mild, score 6-10 was moderate, and score \\>10 was severe."}, {'measure': 'Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice', 'timeFrame': 'From Baseline Visit (Day 1) up to 12 months', 'description': 'Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported.'}, {'measure': 'Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity', 'timeFrame': 'From Baseline Visit (Day 1) up to 12 months', 'description': "Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation."}, {'measure': 'UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index', 'timeFrame': 'At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period', 'description': "The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score \\<2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score \\>10 was severe activity. Higher scores indicating higher disease activity."}, {'measure': 'CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI', 'timeFrame': 'At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period', 'description': 'HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score \\<5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score \\>16 was severe activity. Higher scores indicating higher disease activity.'}, {'measure': 'Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)'}, {'measure': 'Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)'}, {'measure': 'Percentage of Participants Stratified by Achieving the Treatment Goals', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': 'Treat to target (T2T) approach was used for assessment of treatment goals. A "Treat to target" approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein \\[CRP\\] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target.'}, {'measure': 'Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': '"Other" challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT).'}, {'measure': 'Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)'}, {'measure': 'Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries', 'timeFrame': 'From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)', 'description': 'Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Colitis, Ulcerative', 'Crohn Disease', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).", 'detailedDescription': "This is a non-interventional, retrospective and prospective study of participants with IBD. This study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe UC and CD in routine clinical practice.\n\nThe study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. The prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study.\n\nThe study will enroll approximately 2000 participants. Participants will be enrolled in one of the two groups:\n\n* UC Participants\n* CD Participants\n\nThis multi-center trial will be conducted in Russia, Belarus and Kazakhstan. The overall period of observation in this study will be approximately 12 months. Participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at Month 12."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with moderate to severe UC or CD will be observed both retrospectively and prospectively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.\n2. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation.\n3. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.\n\nExclusion Criteria:\n\n1. Current or previous (within the last two years) indeterminate or not classified colitis.\n2. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years.\n3. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial.\n4. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.\n5. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.'}, 'identificationModule': {'nctId': 'NCT03532932', 'acronym': 'INTENT', 'briefTitle': 'A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'International, Multicentre, Non-Interventional Study To Evaluate Disease Control And Treatment Pattern In Patients With Moderate To Severe Inflammatory Bowel Disease In Real Life Practice', 'orgStudyIdInfo': {'id': 'IBD-5005'}, 'secondaryIdInfos': [{'id': 'U1111-1207-6263', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'UC Participants', 'description': "Participants diagnosed with moderate to severe UC from approximately 35 investigational sites will be observed retrospectively for previous 2 years before enrollment until Visit 1 and will be observed prospectively for 1 year after participant's enrollment into the study to assess treatment patterns and treatment outcomes in UC participants particularly on the use of available biological therapies."}, {'label': 'CD Participants', 'description': "Participants diagnosed with moderate to severe CD from approximately 35 investigational sites will be observed retrospectively for previous 2 years before enrollment until Visit 1 and will be observed prospectively for 1 year after participant's enrollment into the study to assess treatment patterns and treatment outcomes in CD participants particularly on the use of available biological therapies."}]}, 'contactsLocationsModule': {'locations': [{'zip': '220077', 'city': 'Minsk', 'state': 'Minsk Oblast', 'country': 'Belarus', 'facility': 'Republican Gastroenterology Center, City Clinical Hospital # 10'}, {'zip': '210601', 'city': 'Vitebsk', 'state': 'Vitebsk Oblast', 'country': 'Belarus', 'facility': 'Vitebsk regional clinical specialized center', 'geoPoint': {'lat': 55.1904, 'lon': 30.2049}}, {'zip': '050000', 'city': 'Almaty', 'state': 'Almaty Region', 'country': 'Kazakhstan', 'facility': 'Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department'}, {'zip': '010000', 'city': 'Astana', 'state': 'Astana', 'country': 'Kazakhstan', 'facility': 'The Centre of Coloproctology based at City Hospital 1', 'geoPoint': {'lat': 51.1801, 'lon': 71.44598}}, {'zip': '160000', 'city': 'Shymkent', 'state': 'Shymkent', 'country': 'Kazakhstan', 'facility': 'Regional clinical hospital', 'geoPoint': {'lat': 42.30988, 'lon': 69.60042}}, {'zip': '656024', 'city': 'Barnaul', 'state': 'Altai Territory', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '450008', 'city': 'Ufa', 'state': 'Bashkortostan Republic', 'country': 'Russia', 'facility': 'Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '454076', 'city': 'Chelyabinsk', 'state': 'Chelyabinsk Oblast', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '664049', 'city': 'Irkutsk', 'state': 'Irkutsk Oblast', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '650066', 'city': 'Kemerovo', 'state': 'Kemerovo Oblast', 'country': 'Russia', 'facility': 'State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '680009', 'city': 'Khabarovsk', 'state': 'Khabarovsk Territory', 'country': 'Russia', 'facility': 'Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"', 'geoPoint': {'lat': 48.46204, 'lon': 135.0971}}, {'zip': '628408', 'city': 'Surgut', 'state': 'Khanty-Mansi Autonomous Okrug-Yugra', 'country': 'Russia', 'facility': 'Budgetary Institution "Surgut District Clinical Hospital"', 'geoPoint': {'lat': 61.25757, 'lon': 73.41775}}, {'zip': '350086', 'city': 'Krasnodar', 'state': 'Krasnodarskiy Kray', 'country': 'Russia', 'facility': 'State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '660123', 'city': 'Krasnoyarsk', 'state': 'Krasnoyarsk Region', 'country': 'Russia', 'facility': 'Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '194044', 'city': 'Saint-Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': 'Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy named after S.Kirov" of the Ministry of Defense of the Russian Federation'}, {'zip': '196143', 'city': 'Saint-Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': 'Scientific and Research Center "Eco-safety", LLC'}, {'zip': '197110', 'city': 'Saint-Petersburg', 'state': "Leningradskaya Oblast'", 'country': 'Russia', 'facility': 'St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"'}, {'zip': '150062', 'city': 'Krasnogorsk', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'MEDSI Clinical Hospital', 'geoPoint': {'lat': 55.81904, 'lon': 37.32984}}, {'zip': '111123', 'city': 'Moscow', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'Moscow Clinical Scientific Center'}, {'zip': '123423', 'city': 'Moscow', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'State Scientific Center of Coloproctology'}, {'zip': '129110', 'city': 'Moscow', 'state': 'Moscow Oblast', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy'}, {'zip': '644111', 'city': 'Omsk', 'state': 'Omsk Oblast', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '614990', 'city': 'Perm', 'state': 'Perm Krai', 'country': 'Russia', 'facility': 'Perm regional clinical hospital', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '295007', 'city': 'Simferopol', 'state': 'Republic Crimea', 'country': 'Russia', 'facility': 'Medical Academy n. a. S. I. Georgievksiy Federal State Autonomous Educational Institution of Higher Education "Crimean State University n. a. V.I. Vernadskiy'}, {'zip': '295017', 'city': 'Simferopol', 'state': 'Republic Crimea', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"'}, {'zip': '185910', 'city': 'Petrozavodsk', 'state': 'Republic of Karelia', 'country': 'Russia', 'facility': 'Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '424037', 'city': 'Yoshkar-Ola', 'state': 'Republic of Maruy El', 'country': 'Russia', 'facility': 'Health Care Unit # 1 of Yoshkar-Ola city', 'geoPoint': {'lat': 56.63877, 'lon': 47.89078}}, {'zip': '390023', 'city': 'Ryazan', 'state': 'Ryazan Oblast', 'country': 'Russia', 'facility': 'State Budgetary Institution of Ryazan Region "City Clinical Hospital #4"', 'geoPoint': {'lat': 54.62696, 'lon': 39.70415}}, {'zip': '620109', 'city': 'Yekaterinburg', 'state': 'Sverdlovsk Oblast', 'country': 'Russia', 'facility': 'Society with limited liability "Medical Association" New Hospital "', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '20064', 'city': "Kazan'", 'state': 'Tatarstan Republic', 'country': 'Russia', 'facility': 'Republican Clinical Hospital Ministry of health Republic of Tatarstan', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '426039', 'city': 'Izhevsk', 'state': 'Udmurtiya Republic', 'country': 'Russia', 'facility': 'Budgetary Institution of Health in the Republic of Udmurtia First Republican Clinical Hospital under the Ministry of Health, the Republic of Udmurtia', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '450005', 'city': 'Ufa', 'state': 'Ufa Region', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '450071', 'city': 'Ufa', 'state': 'Ufa Region', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution City Clinical Hospital 21', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '432017', 'city': 'Ulyanovsk', 'state': 'Ulyanovsk Oblast', 'country': 'Russia', 'facility': 'State Healthcare Institution Ulyanovsk Regional Clinical Hospital', 'geoPoint': {'lat': 54.32824, 'lon': 48.38657}}, {'zip': '600023', 'city': 'Vladimir', 'state': 'Vladimirskaya Oblast’', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 56.13854, 'lon': 40.39976}}, {'zip': '672000', 'city': 'Chita', 'state': 'Zabaykalskiy (Transbaikal) Kray', 'country': 'Russia', 'facility': 'Federal State Budgetary Educational Institution of Higher Education "Chita state medical academy" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 52.04311, 'lon': 113.49171}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}