Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-07 @ 1:46 AM
Study NCT ID:
NCT01597505
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2012-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)
Sponsor:
Organization:
Raw JSON
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{'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50)', 'description': 'All randomized participants who received any amount of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 for 10 days', 'otherNumAtRisk': 305, 'deathsNumAtRisk': 305, 'otherNumAffected': 38, 'seriousNumAtRisk': 305, 'deathsNumAffected': 18, 'seriousNumAffected': 44}, {'id': 'EG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days', 'otherNumAtRisk': 286, 'deathsNumAtRisk': 286, 'otherNumAffected': 38, 'seriousNumAtRisk': 286, 'deathsNumAffected': 9, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Inguinal hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Jejunal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fungal peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Strongyloidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonic convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 305, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 286, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000', 'lowerLimit': '73.9', 'upperLimit': '83.2'}, {'value': '83.6', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '87.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '1.9', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 13 days', 'description': 'A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Response Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '227', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}]}, {'title': 'Day 41', 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.832', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Log-rank test of equality of survival times, stratified by age group (\\< 75, \\>= 75 years) and number of CDAD episodes (0, \\>= 1). Significance cut-off = 0.05', 'groupDescription': 'Stratified log-rank test p-value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 41', 'description': 'Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '66.0'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '55.9', 'upperLimit': '66.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '7.1', 'estimateComment': 'The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 50', 'description': 'Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '55.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 50', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any amount of study drug'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 50', 'description': 'A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any amount of study drug'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}, {'value': '286', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 13', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received any amount of study drug'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants With Sustained Clinical Response at Day 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '66.6', 'groupId': 'OG000', 'lowerLimit': '61.1', 'upperLimit': '71.8'}, {'value': '66.1', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '71.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '8.3', 'estimateComment': 'The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 24', 'description': 'Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants With Recurrence of CDAD at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '22.4'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '26.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '3.0', 'estimateComment': 'The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 50', 'description': 'Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '280', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '3.3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '3.3'}]}]}], 'analyses': [{'pValue': '0.431', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Log-rank test of equality of survival times, stratified by age group (\\< 75, \\>= 75 years) and number of CDAD episodes (0, \\>= 1). Significance cut-off = 0.05', 'groupDescription': 'Stratified Log-Rank p-Value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin was superior to vancomycin if the p-value was less than 0.05'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 13', 'description': 'Time to resolution of diarrhea with =\\< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized'}, {'type': 'SECONDARY', 'title': 'Time to Reappearance of Diarrhea From End of Treatment to the End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median value was not achieved', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median value was not achieved', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Log-rank test of equality of survival times, stratified by age group (\\< 75, \\>= 75 years) and number of CDAD episodes (0, \\>= 1). Significance cut-off = 0.05', 'groupDescription': 'Stratified Log-Rank p-Value', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin was superior to vancomycin if the p-value was less than 0.05'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Day 50', 'description': 'Time to reappearance of diarrhea with \\>= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and were cured at end of treatment.'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '92.4'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '76.2', 'upperLimit': '92.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '14.8', 'estimateComment': 'Treatment group percentages were stratified by age group (\\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 13', 'description': 'Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline.'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '92.2'}, {'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '94.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '3.0', 'estimateComment': 'Treatment group proportions were stratified by age group (\\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 13', 'description': 'Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed is the Per Protocol 1 (PP1) population composed of participants from the mMITT population, according to the actual treatment they received; without any protocol deviations from enrollment through 2 days after end of treatment, which could affect the efficacy conclusions.'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '53.6', 'upperLimit': '76.7'}, {'value': '51.5', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '63.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '30.7', 'estimateComment': 'Treatment group percentages were stratified by age group (\\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 50', 'description': 'Sustained clinical response at the end of study was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who had a clinical outcome of cure at the end of treatment (Day 13) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '70.8', 'groupId': 'OG000', 'lowerLimit': '64.8', 'upperLimit': '76.2'}, {'value': '66.5', 'groupId': 'OG001', 'lowerLimit': '60.6', 'upperLimit': '72.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '12.7', 'estimateComment': 'Treatment group proportions were stratified by age group (\\< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.', 'groupDescription': 'Difference in percentage of participants', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be \\> 0%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 50', 'description': 'Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol 2 (PP2) population composed of cures and failures from the PP1 population. Additionally, to be included in the PP2 population, PP1 participants who were cured at end of treatment must not have had any protocol deviations which could affect the assessment of recurrence and have had follow-up contact through at least Day 40.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days'}, {'id': 'FG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized participants', 'groupId': 'FG000', 'numSubjects': '308'}, {'comment': 'Randomized participants', 'groupId': 'FG001', 'numSubjects': '298'}]}, {'type': 'Treated', 'achievements': [{'comment': 'One participant was instead randomized to vancomycin', 'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '286'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Males and females aged 18 years or older with diarrhea at risk for Clostridium Difficile Associated Diarrhea (CDAD) were enrolled in this study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '606', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Surotomycin', 'description': '250 mg Surotomycin over encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '606', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.5', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '61.8', 'spread': '18.4', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '17.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 75 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}]}, {'title': '>= 75 years old', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants \\<75 or \\>=75 years old at First Dose', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized participants with Confirmed CDAD'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '606', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous episodes of CDAD', 'classes': [{'title': '0 Previous Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '561', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}]}, {'title': '>= 1 Previous Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '561', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with previous episodes of CDAD', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized participants with Confirmed CDAD evaluated for previous episodes of CDAD'}, {'title': 'BI/NAP1/027 Strain', 'classes': [{'title': 'With BI/NAP1/027 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'Without BI/NAP1/027 Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '501', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '375', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with the BI/NAP1/027 Strain', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized participants with Confirmed CDAD evaluated for BI/NAP1/027 Strain'}]}}, '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': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2012-05-10', 'resultsFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2012-05-11', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-26', 'studyFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)', 'timeFrame': 'Up to 13 days', 'description': 'A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.'}, {'measure': 'Percentage of Participants With at Least One Adverse Event (AE)', 'timeFrame': 'Up to Day 50', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).'}, {'measure': 'Percentage of Participants With at Least One Serious Adverse Event (SAE)', 'timeFrame': 'Up to Day 50', 'description': 'A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.'}, {'measure': 'Percentage of Participants Who Discontinued Treatment Due to an AE', 'timeFrame': 'Up to Day 13', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Clinical Response Over Time', 'timeFrame': 'Up to Day 41', 'description': 'Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).'}, {'measure': 'Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study', 'timeFrame': 'Up to Day 50', 'description': 'Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}, {'measure': 'Adjusted Percentage of Participants With Sustained Clinical Response at Day 24', 'timeFrame': 'Day 24', 'description': 'Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}, {'measure': 'Adjusted Percentage of Participants With Recurrence of CDAD at End of Study', 'timeFrame': 'Up to Day 50', 'description': 'Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}, {'measure': 'Time to Resolution of Diarrhea', 'timeFrame': 'Up to Day 13', 'description': 'Time to resolution of diarrhea with =\\< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.'}, {'measure': 'Time to Reappearance of Diarrhea From End of Treatment to the End of Study', 'timeFrame': 'Up to Day 50', 'description': 'Time to reappearance of diarrhea with \\>= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.'}, {'measure': 'Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline', 'timeFrame': 'Up to Day 13', 'description': 'Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}, {'measure': 'Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment', 'timeFrame': 'Up to Day 13', 'description': 'Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}, {'measure': 'Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline', 'timeFrame': 'Up to Day 50', 'description': 'Sustained clinical response at the end of study was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who had a clinical outcome of cure at the end of treatment (Day 13) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}, {'measure': 'Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study', 'timeFrame': 'Up to Day 50', 'description': 'Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CDAD', 'Clostridium difficile Associated Diarrhea', 'CDI', 'Clostridium difficile Infection', 'Diarrhea'], 'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '28480267', 'type': 'RESULT', 'citation': 'Boix V, Fedorak RN, Mullane KM, Pesant Y, Stoutenburgh U, Jin M, Adedoyin A, Chesnel L, Guris D, Larson KB, Murata Y. Primary Outcomes From a Phase 3, Randomized, Double-Blind, Active-Controlled Trial of Surotomycin in Subjects With Clostridium difficile Infection. Open Forum Infect Dis. 2017 Jan 19;4(1):ofw275. doi: 10.1093/ofid/ofw275. eCollection 2017 Winter.'}, {'pmid': '32747931', 'type': 'DERIVED', 'citation': 'Cheknis A, Devaris D, Chesnel L, Dale SE, Nary J, Sambol SP, Citron DM, Goering RV, Johnson S. Characterization of Clostridioides difficile isolates recovered from two Phase 3 surotomycin treatment trials by restriction endonuclease analysis, PCR ribotyping and antimicrobial susceptibilities. J Antimicrob Chemother. 2020 Nov 1;75(11):3120-3125. doi: 10.1093/jac/dkaa297.'}]}, 'descriptionModule': {'briefSummary': '606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. The purpose of this study was to evaluate how well surotomycin treats CDAD as compared to vancomycin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "To be included in this study, participants must:\n\n* Sign a consent form;\n* Be \\>= 18 and \\< 90 years of age;\n* Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;\n* Test positive for Clostridium difficile;\n* If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.\n\nParticipants will not be allowed into the study if they:\n\n* Have toxic megacolon and/or known small bowel ileus;\n* Have received treatment with intravenous immune globulin (IVIG) within the past 30 days;\n* Have received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;\n* Have received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;\n* Have received an investigational vaccine against C. difficile;\n* Have received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;\n* Had more than 2 episodes of CDAD within 90 days;\n* Had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy);\n* Have history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;\n* Are unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;\n* Are unable to discontinue opiate treatment unless on a stable dose;\n* Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;\n* Had stool studies positive for pathogenic ova and/or parasites;\n* Have an intolerance or hypersensitivity to daptomycin and/or vancomycin;\n* Have life-threatening illness at the time of enrollment;\n* Have poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;\n* Have received an investigational drug or participated in any experimental procedure within 1 month;\n* Have human immunodeficiency virus (HIV), a cluster of differentiation 4 (CD4) \\< 200 cells/mm3 within 6 months of start of study therapy;\n* Anticipate that certain antibacterial therapy for a non-CDAD infection will be required for \\> 7 days;\n* Are unable to discontinue Saccharomyces or similar probiotic;\n* Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;\n* Are unable to comply with the protocol requirements;\n* Have any condition that, in the opinion of the Investigator, might interfere;\n* Are not expected to live for less than 8 weeks."}, 'identificationModule': {'nctId': 'NCT01597505', 'briefTitle': 'Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea', 'orgStudyIdInfo': {'id': '4261-005'}, 'secondaryIdInfos': [{'id': 'LCD-CDAD-10-07', 'type': 'OTHER', 'domain': 'Cubist Study Number'}, {'id': 'MK-4261-005', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}, {'id': '2012-000252-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surotomycin', 'description': '250 mg Surotomycin over- encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days', 'interventionNames': ['Drug: Surotomycin', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Surotomycin', 'type': 'DRUG', 'otherNames': ['CB-183,315'], 'description': '250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days', 'armGroupLabels': ['Surotomycin']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': '125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days', 'armGroupLabels': ['Vancomycin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days', 'armGroupLabels': ['Surotomycin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}