Viewing Study NCT00545103

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Ignite Creation Date: 2025-12-24 @ 7:36 PM
Ignite Modification Date: 2026-02-20 @ 3:37 PM
Study NCT ID: NCT00545103
Status: COMPLETED
Last Update Posted: 2021-06-11
First Post: 2007-10-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Prevention of Recurrence of Diverticulitis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004238', 'term': 'Diverticulitis'}], 'ancestors': [{'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily', 'otherNumAtRisk': 148, 'otherNumAffected': 108, 'seriousNumAtRisk': 148, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily', 'otherNumAtRisk': 147, 'otherNumAffected': 111, 'seriousNumAtRisk': 147, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily', 'otherNumAtRisk': 149, 'otherNumAffected': 110, 'seriousNumAtRisk': 149, 'seriousNumAffected': 14}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily', 'otherNumAtRisk': 142, 'otherNumAffected': 105, 'seriousNumAtRisk': 142, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 11}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 11}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 7}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 9}], 'organSystem': 'Infections and infestations'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 13}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 8}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Gastroesophogeal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Small intestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Multi-organ failure/Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Peridiverticular abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Borrelia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Viral pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Post procedural edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Ovarian granulosa-theca cell tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cardiac neoplasm unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Intra-abdominal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Subjects Without Recurrence of Diverticulitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '59.2', 'groupId': 'OG001'}, {'value': '69.1', 'groupId': 'OG002'}, {'value': '67.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.778', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.159', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.368', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 Weeks', 'description': 'Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'groupId': 'OG000'}, {'value': '59.2', 'groupId': 'OG001'}, {'value': '69.1', 'groupId': 'OG002'}, {'value': '66.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.685', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.198', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.441', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 weeks', 'description': 'CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening \\>5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Presence of abdominal pain', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': '15% increase in WBC from baseline', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain + 15% increase in WBC', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 Weeks', 'description': 'A positive CT scan was defined as a CT scan that showed bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.', 'unitOfMeasure': 'Number of CT Scans', 'reportingStatus': 'POSTED', 'populationDescription': 'Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.'}, {'type': 'SECONDARY', 'title': 'Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Presence of abdominal pain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': '15% increase in WBC from Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain + 15% increase in WBC', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 weeks', 'description': 'A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.', 'unitOfMeasure': 'Number of CT Scans', 'reportingStatus': 'POSTED', 'populationDescription': 'Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.'}, {'type': 'SECONDARY', 'title': 'Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Presence of abdominal pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '15% increase in WBC from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain + 15% increase in WBC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 weeks', 'description': 'A positive CT scan was defined as a CT scan that showed bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.', 'unitOfMeasure': 'Number of CT Scans', 'reportingStatus': 'POSTED', 'populationDescription': 'Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.'}, {'type': 'SECONDARY', 'title': 'Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Presence of abdominal pain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '15% increase in WBC from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Abdominal pain + 15% increase in WBC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 weeks', 'description': 'A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.', 'unitOfMeasure': 'Number of CT Scans', 'reportingStatus': 'POSTED', 'populationDescription': 'Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.'}, {'type': 'SECONDARY', 'title': 'Percent of Subjects Requiring Surgery for Diverticulitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'OG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'OG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '2.0', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 104 Weeks', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'FG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'FG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '150'}, {'groupId': 'FG003', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Suspected recurrence of diverticulitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Difficult to open package', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Investigational product not taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Wish to start a family', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Diverticulitis crisis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Personal reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Subject's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Use of prohibited medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Does not want to take study drug anymore', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject met endpoint under protocol v. 1', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '586', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'SPD476 (1.2 g)', 'description': '1.2 g administered orally once daily'}, {'id': 'BG001', 'title': 'SPD476 (2.4 g)', 'description': '2.4 g administered orally once daily'}, {'id': 'BG002', 'title': 'SPD476 (4.8 g)', 'description': '4.8 g administered orally once daily'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo administered orally once daily'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '11.76', 'groupId': 'BG002'}, {'value': '55.7', 'spread': '11.15', 'groupId': 'BG003'}, {'value': '56.1', 'spread': '11.04', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 to < 35 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': '35 to < 45 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}, {'title': '45 to < 55 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '173', 'groupId': 'BG004'}]}]}, {'title': '55 to < 65 years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '314', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '272', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '351', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This baseline measure consists of all randomized subjects (n = 592).', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 592}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2011-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2007-10-16', 'resultsFirstSubmitDate': '2012-10-11', 'studyFirstSubmitQcDate': '2007-10-16', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-11-19', 'studyFirstPostDateStruct': {'date': '2007-10-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Subjects Without Recurrence of Diverticulitis', 'timeFrame': 'up to 104 Weeks', 'description': 'Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.'}], 'secondaryOutcomes': [{'measure': 'Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis', 'timeFrame': 'up to 104 weeks', 'description': 'CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening \\>5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.'}, {'measure': 'Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive', 'timeFrame': 'up to 104 Weeks', 'description': 'A positive CT scan was defined as a CT scan that showed bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.'}, {'measure': 'Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative', 'timeFrame': 'up to 104 weeks', 'description': 'A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.'}, {'measure': 'Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive', 'timeFrame': 'up to 104 weeks', 'description': 'A positive CT scan was defined as a CT scan that showed bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.'}, {'measure': 'Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative', 'timeFrame': 'up to 104 weeks', 'description': 'A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\\>5 mm) and/or fat stranding as read by the central reader.'}, {'measure': 'Percent of Subjects Requiring Surgery for Diverticulitis', 'timeFrame': 'up to 104 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diverticulitis']}, 'referencesModule': {'references': [{'pmid': '25038431', 'type': 'DERIVED', 'citation': 'Raskin JB, Kamm MA, Jamal MM, Marquez J, Melzer E, Schoen RE, Szaloki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females =\\>18yrs of age.\n2. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol\n3. An episode of acute diverticulitis that resolved without colonic resection.\n4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted\n\nExclusion Criteria:\n\n1. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)\n2. Active peptic ulcer disease\n3. History of or current presence of inflammatory bowel disease (IBD)\n4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication\n5. Allergy or hypersensitivity to aspirin or related compounds\n6. Allergy to radiologic contrast agents\n7. Use of another Investigational product within 30 days of Baseline\n8. Use of antibiotic therapy within 4 weeks of Baseline\n9. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents\n10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable\n11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis\n12. History of alcohol or other substance abuse within the previous year\n13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline\n14. Females who are lactating'}, 'identificationModule': {'nctId': 'NCT00545103', 'acronym': 'PREVENT2', 'briefTitle': 'Prevention of Recurrence of Diverticulitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.', 'orgStudyIdInfo': {'id': 'SPD476-314'}, 'secondaryIdInfos': [{'id': '2007-004896-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPD476 (1.2 g)', 'interventionNames': ['Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'SPD476 (2.4 g)', 'interventionNames': ['Drug: SPD476, MMX™ mesalazine, 2.4g extended release tablet']}, {'type': 'EXPERIMENTAL', 'label': 'SPD476 (4.8 g)', 'interventionNames': ['Drug: SPD476, MMX™ mesalazine, 4.8g extended release tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SPD476, MMX™ mesalazine, 1.2g extended release tablet', 'type': 'DRUG', 'otherNames': ['LIALDA'], 'description': 'SPD476 1.2g administered Once Daily (QD)', 'armGroupLabels': ['SPD476 (1.2 g)']}, {'name': 'SPD476, MMX™ mesalazine, 2.4g extended release tablet', 'type': 'DRUG', 'otherNames': ['LIALDA'], 'description': 'SPD476 2.4g administered Once Daily (QD)', 'armGroupLabels': ['SPD476 (2.4 g)']}, {'name': 'SPD476, MMX™ mesalazine, 4.8g extended release tablet', 'type': 'DRUG', 'otherNames': ['LIALDA'], 'description': 'SPD476 4.8g administered Once Daily (QD)', 'armGroupLabels': ['SPD476 (4.8 g)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered Once Daily (QD)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Gastroenterology Associates, PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Center, Inc', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35802', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Digestive Disorders Center, PC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genova Clinical Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92840', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Digestive and Liver Disease Specialists', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'High Desert Gastroenterology, Inc.', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92083', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'CA Physicians Research Alliance', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '94070', 'city': 'San Carlos', 'state': 'California', 'country': 'United States', 'facility': 'Digestive Care Medical Center', 'geoPoint': {'lat': 37.50716, 'lon': -122.26052}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Rider Research Group', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91108', 'city': 'San Marino', 'state': 'California', 'country': 'United States', 'facility': 'Huntington Medical Foundation', 'geoPoint': {'lat': 34.1214, 'lon': -118.10646}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinical Research of the Rockies', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Arapahoe Gastroenterology, PC', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06790', 'city': 'Torrington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Litchfield County Gastroenterology Associates, LLC', 'geoPoint': {'lat': 41.80065, 'lon': -73.12122}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Madeleine DuPree, MD', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Palmetto Research LLC', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Mark Lamet, MD', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Digestive Disease Consultants', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32168', 'city': 'New Smyrna Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'United Medical Research', 'geoPoint': {'lat': 29.02582, 'lon': -80.927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "West Wind'r Research & Development", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30067', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Gastroenterology Associates', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '52807', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Gastrointestinal Clinical of Quad Cities', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '66202', 'city': 'Mission', 'state': 'Kansas', 'country': 'United States', 'facility': 'Sunflower Medical Group', 'geoPoint': {'lat': 39.02778, 'lon': -94.65579}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 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