Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-26 @ 2:23 PM
Study NCT ID:
NCT05214768
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'C535952', 'term': 'Eosinophilic enteropathy'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625155', 'term': 'cendakimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality, serious and non-serious adverse events were collected from first dose (day 1) and up to 121 weeks.', 'description': 'All-cause mortality, serious and non-serious adverse events were collected for all participants who received at least one dose of IP. As pre-specified adverse events for participants that discontinued Induction period without entering maintenance period were collected in the CC-93538 360 mg QW arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Induction and Maintenance - CC-93538 360mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Maintenance - CC-93538 360mg QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Induction and Maintenance - Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Open-label Long-term Extension Phase - CC-93538 360mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis earlier randomized to Induction and Maintenance phase received 360 mg CC-93538 subcutaneously (SC) once weekly in Open-Label Long-term Extension phase.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 30, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Diabetes 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'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Essential tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intermenstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eosinophilic bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'NSAID exacerbated respiratory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hand dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-100.4', 'spread': '44.23', 'groupId': 'OG000'}, {'value': '122.8', 'spread': '60.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-223.2', 'ciLowerLimit': '-370.2', 'ciUpperLimit': '-76.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '74.98', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.', 'unitOfMeasure': 'Peak # of eosinophils counted per field', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'title': 'Heartburn Symptoms domain', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Gastric Pain Symptoms domain', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Stomach Heaviness Symptoms domain', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Symptoms domain', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Symptoms domain', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo).'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'title': 'Heartburn Symptoms domain', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.84', 'groupId': 'OG002'}]}]}, {'title': 'Gastric Pain Symptoms domain', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'Stomach Heaviness Symptoms domain', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.90', 'groupId': 'OG002'}]}]}, {'title': 'Constipation Symptoms domain', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.85', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea Symptoms domain', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '0.97', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Clinical response defined as percentage of participants who achieve \\<4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 48', 'description': 'Clinical response defined as percentage of participants who achieve \\<4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.1', 'spread': '61.26', 'groupId': 'OG000'}, {'value': '-151.2', 'spread': '89.70', 'groupId': 'OG001'}, {'value': '98.6', 'spread': '66.03', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm', 'unitOfMeasure': 'Peak # of eosinophils counted per field', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants with baseline measurements of peak eos analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.4', 'spread': '18.85', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '22.18', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '29.78', 'groupId': 'OG000'}, {'value': '-39.9', 'spread': '50.54', 'groupId': 'OG001'}, {'value': '43.7', 'spread': '36.15', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants with baseline measurements of peak eos analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo).'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '31.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 48', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a scale of "0 = No trouble at all" to "5 = Can\'t stand it," and one symptom domain is scored from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.4', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '2.91', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '2.12', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 16', 'description': 'The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified at specified timepoint are included in the analysis. Only participants from ages \\>=20 years years old at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.32', 'groupId': 'OG001'}, {'value': '-7.2', 'spread': '3.35', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', 'description': 'The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis. Only participants from ages \\>=20 years old at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'title': 'EGE Flare', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': 'NA'}]}]}, {'title': 'Use of rescue therapy', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': '113', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Week 16', 'description': 'Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline).', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the participant received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'title': 'EGE Flare', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG002', 'lowerLimit': '113', 'upperLimit': 'NA'}]}]}, {'title': 'Use of rescue therapy', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG002', 'lowerLimit': '115', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through Week 48', 'description': 'Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline). Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo). Only participants analyzed at specified timepoint are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG000', 'lowerLimit': '144', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG001', 'lowerLimit': '176', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimated due to insufficient number of events', 'groupId': 'OG002', 'lowerLimit': '113', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 16 through Week 48', 'description': 'Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population which consists of all randomized participants regardless of whether or not the subject received IP (CC-93538 or placebo).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24, 32, 40 and 48', 'description': 'Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Moderate or Severe TEAE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'ANY TEAE suspected to be related to study drug', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'A treatment emergent adverse event (TEAE) is any AE that emerges during treatment or Safety Follow-up Period having been absent pre-treatment or worsens in severity relative to the pretreatment state. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Induction and Maintenance: Number of Participants With Anti-Drug-Antibody', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 till Week 48', 'description': 'Blood samples were collected to assess Anti-Drug-Antibody. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Induction Phase: CC-93538 Trough Concentration at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '179472.2', 'spread': '47.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 16', 'description': 'Blood samples were collected to assess CC-93538 trough concentrations.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population included all participants who received at least one dose of active drug and have at least one measurable concentration data. Only participants with data available at specified timepoint and receiving CC-93538 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: CC-93538 Trough Concentration at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'OG001', 'title': 'CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '165591.7', 'spread': '58.5', 'groupId': 'OG000'}, {'value': '76433.4', 'spread': '64.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Blood samples were collected to assess CC-93538 trough concentrations. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic population included all participants who received at least one dose of active drug and have at least one measurable concentration data. Only participants with data available at specified timepoint and receiving CC-93538 were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Induction Phase - CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase.'}, {'id': 'FG001', 'title': 'Induction Phase - Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase.'}, {'id': 'FG002', 'title': 'Maintenance Phase - CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the maintenance phase.'}, {'id': 'FG003', 'title': 'Maintenance Phase - CC-93538 360 QW/Q2W', 'description': 'Participants with Eosinophilic Gastroenteritis who were randomized to receive 360 mg CC-93538 once weekly in Induction Phase received CC-93538 360 mg SC once every other week for 32 weeks during Maintenance Phase.'}, {'id': 'FG004', 'title': 'Maintenance Phase - Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the maintenance phase.'}, {'id': 'FG005', 'title': 'Open-Label Extension - CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the open-label extension period.'}], 'periods': [{'title': 'Induction Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '25 completed induction phase and 5 directly entered OLE phase', 'groupId': 'FG000', 'numSubjects': '30'}, {'comment': '12 completed induction phase and 4 directly entered OLE phase', 'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '2 out of 13 entered in OLE phase', 'groupId': 'FG002', 'numSubjects': '13'}, {'comment': '1 out of 12 entered in OLE phase', 'groupId': 'FG003', 'numSubjects': '12'}, {'comment': '1 out of 12 participant in OLE phase', 'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'All 11 participants entered OLE phase', 'groupId': 'FG002', 'numSubjects': '11'}, {'comment': '9 out of 10 participants entered OLE phase', 'groupId': 'FG003', 'numSubjects': '10'}, {'comment': 'All 11 participants entered OLE phase', 'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': '9 participants from induction and 35 participants from maintenance entered in this arm.', 'groupId': 'FG005', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Ongoing Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '42'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CC-93538 360 mg QW', 'description': 'Participants with Eosinophilic Gastroenteritis received 360 mg CC-93538 subcutaneously (SC) once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants with Eosinophilic Gastroenteritis received matching placebo once weekly in the induction phase and once weekly for 32 weeks in Maintenance Phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.8', 'spread': '16.79', 'groupId': 'BG000'}, {'value': '41.8', 'spread': '17.63', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '16.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-20', 'size': 1597000, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-01T10:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2022-01-12', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-01', 'studyFirstPostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies', 'timeFrame': 'Baseline and Week 16', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.'}], 'secondaryOutcomes': [{'measure': 'Induction Phase: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 16', 'timeFrame': 'Baseline and Week 16', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.'}, {'measure': 'Induction + Maintenance: Changes in Each of 5 Domain Scores of the Izumo Scale From Baseline at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction Phase: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 16', 'timeFrame': 'Week 16', 'description': 'Clinical response defined as percentage of participants who achieve \\<4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.'}, {'measure': 'Induction + Maintenance: Percentage of Participants Who Achieve Both Clinical and Histologic Response Composite at Week 48', 'timeFrame': 'Baseline and week 48', 'description': 'Clinical response defined as percentage of participants who achieve \\<4/15 in each of three Symptoms of Interest (Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain) scores of Izumo Scale from baseline. Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline. Izumo Scale tests 5 different GI symptom domains during past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Ques1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Ques7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Ques13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and score for each question within a domain added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity.'}, {'measure': 'Induction + Maintenance: Change From Baseline in Mean Number of Peak Eosinophils (Eos) Count Per High-power Field (Hpf) in Gastrointestinal (GI) Biopsies at Week 48', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm'}, {'measure': 'Induction Phase: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline', 'timeFrame': 'Baseline and Week 16', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase.'}, {'measure': 'Induction + Maintenance: Percent Changes in Mean Number of Peak Eos Per Hpf in GI Biopsies From Baseline', 'timeFrame': 'Baseline and Week 48', 'description': 'Blood samples were collected to assess eosinophils count. Baseline data are defined as last measurement collected on or prior the date of first dose for Induction Phase. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction Phase: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)', 'timeFrame': 'Week 16', 'description': 'Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline.'}, {'measure': 'Induction + Maintenance: Percentage of Participants With Eosinophil Histologic Response (> 75% Reduction)', 'timeFrame': 'Week 48', 'description': 'Histologic response defined as a \\> 75% reduction of peak gastric and/or duodenal eos count from baseline. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction Phase: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale', 'timeFrame': 'Week 16', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a 6-point Likert scale of "0 = No trouble at all" to "5 = Can\'t stand it," and the score for each question within a domain is added to determine domain specific scores scaled from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest.'}, {'measure': 'Induction + Maintenance: Percentage of Participants Who Achieve <4/15 in Each of Three Symptoms of Interest Scores Using the Izumo Scale', 'timeFrame': 'Baseline and Week 48', 'description': 'The Izumo Scale questionnaire assesses the comprehensive 5 different GI symptom domains during the past week and consists with 15 weekly questions (3 questions per 1 domain): Heartburn Symptoms domain(Questions1 through3), Gastric Pain Symptoms domain(Questions4 through6), Stomach Heaviness Symptoms domain(Questions7 through9), Constipation Symptoms domain (Question 10 through12), Diarrhea Symptoms domain (Questions13 through15). Each question is scored on a scale of "0 = No trouble at all" to "5 = Can\'t stand it," and one symptom domain is scored from 0 to 15, with higher values indicating greater symptom severity. Gastric Pain Symptoms domain, Stomach Heaviness Symptoms domain, and Diarrhea Symptoms domain are Symptoms of Interest. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm. Only participants from ages 12 -19 years old at specified timepoint are included in the analysis.'}, {'measure': 'Induction Phase: Changes in Total Score of Eosinophilic Gastrointestinal Disorder (EGID) Severity Score From Baseline to Weeks 16 in Adolescent (12 to 19 Years)', 'timeFrame': 'Baseline and Week 16', 'description': 'The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild.'}, {'measure': 'Induction Phase: Changes in Total Score of EGID Severity Score From Baseline to Weeks 16 in Adults (>= 20 Years)', 'timeFrame': 'Baseline and Week 16', 'description': 'The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild.'}, {'measure': 'Induction+ Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adolescent (12 to 19 Years)', 'timeFrame': 'Baseline and Week 48', 'description': 'The EGID Severity Score for participants from 12 to 19 years old assesses 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and general condition, including height and weight. The score ranges from 0 to 100 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction + Maintenance: Changes in Total Score of EGID Severity Score From Baseline to Weeks 48 in Adults (>= 20 Years)', 'timeFrame': 'Baseline and Week 48', 'description': 'The EGID Severity Scores are assessed by the investigator. The EGID Severity Score for participants ≥ 20 years old assess the intensity and the frequency of 6 different symptoms (vomiting, dysphagia, anorexia, abdominal pain, diarrhea, bloody stool), 2 clinical laboratory tests (albumin, eos ratio of peripheral blood cells) and 2 medical history items (history of surgery and use of systemic corticosteroid or immunosuppressives). The score ranges from 0 to 82 and the higher the score, the greater the severity. A score of ≥ 40 is considered as severe, a score of 15 to 39 as moderate and a score of ≤ 14 score as mild. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction Phase: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy', 'timeFrame': 'Through Week 16', 'description': 'Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline).'}, {'measure': 'Induction + Maintenance: Time to First Event of Eosinophilic Gastroenteritis (EGE) Flare and First Use of Rescue Therapy', 'timeFrame': 'Through Week 48', 'description': 'Any worsening of EGE symptoms during study participation will be documented as an EGE flare. Worsening of EGE symptoms is defined as continuous worsening of symptoms for 2 consecutive visits (4 weeks apart) compared to baseline, measured by the weekly Izumo Scale score (≥ 4 weeks of no change from baseline or ≥ 4 weeks of worsening from baseline). Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Maintenance Phase: Time to Reduce to Zero Concomitant Corticosteroid Use', 'timeFrame': 'From Week 16 through Week 48', 'description': 'Participants who use concomitant corticosteroid at baseline and entered Maintenance Phase'}, {'measure': 'Percentage of Participants for Whom the Dose of Concomitant Steroids is Reduced to Zero', 'timeFrame': 'Week 24, 32, 40 and 48', 'description': 'Participants who use concomitant corticosteroid at baseline and entered Maintenance period were included in the analysis.'}, {'measure': 'Induction and Maintenance: Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'A treatment emergent adverse event (TEAE) is any AE that emerges during treatment or Safety Follow-up Period having been absent pre-treatment or worsens in severity relative to the pretreatment state. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Vital Signs Measurements', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction and Maintenance: Number of Participants With Remarkable Differences of Clinically Relevant Mean Changes From Baseline in Physical Examinations Parameters', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction and Maintenance: Number of Participants With Mean Changes Over Time That Were of Clinically Concern in Hematology Parameters, Serum Chemistry Parameters, and Urinalysis Parameters', 'timeFrame': 'From Day 1 untill Week 48', 'description': 'Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction and Maintenance: Number of Participants With Anti-Drug-Antibody', 'timeFrame': 'From Day 1 till Week 48', 'description': 'Blood samples were collected to assess Anti-Drug-Antibody. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}, {'measure': 'Induction Phase: CC-93538 Trough Concentration at Week 16', 'timeFrame': 'Week 16', 'description': 'Blood samples were collected to assess CC-93538 trough concentrations.'}, {'measure': 'Maintenance Phase: CC-93538 Trough Concentration at Week 48', 'timeFrame': 'Week 48', 'description': 'Blood samples were collected to assess CC-93538 trough concentrations. Participants that discontinued Induction period without entering maintenance period are included in the CC-93538 360 mg QW arm.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eosinophilic Gastroenteritis', 'CC-93538', 'Gastrointestinal Diseases', 'Eosinophilic Gastro-Intestinal Disorder', 'EGID', 'Digestive system diseases', 'Gastroenteritis'], 'conditions': ['Eosinophilic Gastroenteritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of CC-93538 in adult and adolescent participants with eosinophilic gastroenteritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic evidence of eosinophilic gastroenteritis (EGE) defined as ≥ 30 eosinophils (eos)/high-power field (hpf) in at least 5 hpf in the stomach and/or ≥ 30 eos/hpf in at least 3 hpf in the duodenum while on stable background therapy for EGE\n* Has weekly symptom scores of ≥ 4/15 for any of Gastric Pain Symptoms domain, Stomach Heaviness Symptom domains, and /or Diarrhea Symptoms domain as assessed by the Izumo Scale with electronic device for the 2 consecutive weeks before Day 1\n* Must agree to maintain a stable diet from the first Screening Visit and throughout the duration of the study, and participants must have maintained a stable diet for at least 4 weeks prior to the first Screening Visit\n* Females of childbearing potential must have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy and agree to practice a highly effective method of contraception until 5 months after the last dose\n\nExclusion Criteria:\n\n* Ascites requiring treatment or symptomatic ascites\n* History of inflammatory bowel disease, achalasia or esophageal surgery\n* Has other causes of gastric and/or duodenal eosinophilia or eosinophilic granulomatosis with polyangiitis (EGPA)\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05214768', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Participants With Eosinophilic Gastroenteritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Japanese Subjects With Eosinophilic Gastroenteritis', 'orgStudyIdInfo': {'id': 'CC-93538-EG-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CC-93538', 'interventionNames': ['Drug: CC-93538']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CC-93538', 'type': 'DRUG', 'otherNames': ['Cendakimab', 'BMS-986355'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['CC-93538']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5011194', 'city': 'Gifu', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Local Institution - 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