Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2026-02-22 @ 3:57 PM
Study NCT ID:
NCT01987895
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2013-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Brazil', 'Canada', 'France', 'Germany', 'Italy', 'Netherlands', 'Peru', 'Poland', 'Romania', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591679', 'term': 'cadazolid'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-disclosure@its.jnj.com', 'phone': '0041615656565', 'title': 'Clinical Trial disclosure Desk', 'organization': 'Actelion Pharmaceuticals Ltd'}, 'certainAgreement': {'otherDetails': 'Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation. Upon review, Actelion may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious and frequent adverse events are reported from study treatment initiation up to Day 17 on average (i.e., 7 days after end-of-treatment or study withdrawal) and all-cause mortality up to Day 40 on average (i.e. 28 to 32 days after end-of-treatment or study withdrawal)', 'eventGroups': [{'id': 'EG000', 'title': 'Cadazolid', 'description': '304 subjects received at least one dose of cadazolid and were included in the safety analysis. The median duration of treatment with cadazolid was 10 days.', 'otherNumAtRisk': 304, 'deathsNumAtRisk': 304, 'otherNumAffected': 33, 'seriousNumAtRisk': 304, 'deathsNumAffected': 7, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Vancomycin', 'description': '322 subjects received at least one dose of vancomycin and were included in the safety analysis. The median duration of treatment with vancomycin was 10 days.', 'otherNumAtRisk': 322, 'deathsNumAtRisk': 322, 'otherNumAffected': 49, 'seriousNumAtRisk': 322, 'deathsNumAffected': 7, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute chest syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Biliary anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cellulitis of male external genital organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastatic carcinoma of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peritonitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rectal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 304, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 322, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '87.5'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '80.9', 'upperLimit': '88.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '4.3', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '3.2', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'groupDescription': 'Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 12 on average (end-of-treatment + 2 days)', 'description': 'Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT.\n\nCCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.'}, {'type': 'PRIMARY', 'title': 'Clinical Cure Rate (CCR) in the Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '87.6', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '90.9'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '94.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '1.0', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson' score method", 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 12 on average (end-of-treatment + 2 days)', 'description': 'Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.'}, {'type': 'SECONDARY', 'title': 'Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '60.0', 'upperLimit': '70.7'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '56.8', 'upperLimit': '67.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '10.8', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero'}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)', 'description': 'Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates for Resolution of Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '52.5'}, {'value': '45.9', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '51.6'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000', 'lowerLimit': '57.2', 'upperLimit': '68.0'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '66.1'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '74.9'}, {'value': '71.1', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '76.0'}]}]}, {'title': 'Day 4', 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000', 'lowerLimit': '67.7', 'upperLimit': '77.7'}, {'value': '77.7', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '82.1'}]}]}, {'title': 'Day 5', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '82.3'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '75.6', 'upperLimit': '84.4'}]}]}, {'title': 'Day 6', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '85.3'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '85.8'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '78.0', 'upperLimit': '86.5'}, {'value': '84.6', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '88.3'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '87.4'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '88.9'}]}]}, {'title': 'Day 9', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '87.7'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '88.9'}]}]}, {'title': 'Day 10', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '87.7'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '88.9'}]}]}], 'analyses': [{'pValue': '0.6016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.14', 'pValueComment': 'two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 10', 'description': 'Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment.\n\nThe Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point.', 'unitOfMeasure': 'KM estimate (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analyses were performed on the modified intention-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'title': 'Diarrhea symptoms', 'categories': [{'measurements': [{'value': '-1.233', 'groupId': 'OG000', 'lowerLimit': '-1.37', 'upperLimit': '-1.09'}, {'value': '-1.235', 'groupId': 'OG001', 'lowerLimit': '-1.37', 'upperLimit': '-1.10'}]}]}, {'title': 'Abdominal symptoms', 'categories': [{'measurements': [{'value': '-0.623', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '-0.51'}, {'value': '-0.710', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '-0.60'}]}]}, {'title': 'Other symptoms', 'categories': [{'measurements': [{'value': '-0.639', 'groupId': 'OG000', 'lowerLimit': '-0.74', 'upperLimit': '-0.54'}, {'value': '-0.689', 'groupId': 'OG001', 'lowerLimit': '-0.79', 'upperLimit': '-0.59'}]}]}], 'analyses': [{'pValue': '0.9814', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.002', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.20', 'pValueComment': 'Two-sided 5% alpha level was used', 'estimateComment': 'The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements', 'groupDescription': 'Comparison of the diarrhea domain scores', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.'}, {'pValue': '0.2879', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.087', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.25', 'pValueComment': 'Two-sided 5% alpha level was used', 'estimateComment': 'The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements', 'groupDescription': 'Comparison of the abdominal symptoms domain scores', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12'}, {'pValue': '0.4880', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.050', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.19', 'pValueComment': 'Two-sided 5% alpha level was used', 'estimateComment': 'The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements', 'groupDescription': 'Comparison of the systemic / other symptoms domain scores', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (baseline) and Day 3', 'description': 'CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms. The least squares means (LSM) are computed on the scores.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '92.7'}, {'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '87.9', 'upperLimit': '94.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '2.9', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'groupDescription': 'Exploratory analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)', 'description': "ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '94.8'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '90.8', 'upperLimit': '96.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '2.3', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'groupDescription': 'Exploratory analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)', 'description': "ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5", 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '78.5'}, {'value': '70.1', 'groupId': 'OG001', 'lowerLimit': '64.9', 'upperLimit': '74.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.7', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '10.7', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'groupDescription': 'Exploratory analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)', 'description': "ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis.\n\nISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT).", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sustained Cure Rate (SCR) in the Per-protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '63.2', 'upperLimit': '73.9'}, {'value': '67.7', 'groupId': 'OG001', 'lowerLimit': '62.1', 'upperLimit': '72.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference between 2 proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '8.7', 'estimateComment': "CI for the difference between two proportions are estimated using the Wilson's score method", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Sensitivity analysis'}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)', 'description': 'Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Recurrence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '19.9'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '26.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)', 'description': 'Recurrence is defined as the occurrence of a new episode of diarrhea (\\> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects from the modified intent-to-treat analysis set with clinical cure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cadazolid', 'description': 'Subjects with Clostridium difficile-associated diarrhea (CDAD) received oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times a day (qid) for 10 days. Subjects were followed up for 30 days after the last dose of cadazolid. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 day of cadazolid + 30-day follow up)'}, {'id': 'FG001', 'title': 'Vancomycin', 'description': 'Subjects with CDAD received oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days. Subjects were followed up for 30 day after the last dose of vancomycin. Subjects who had a first recurrence of CDAD during the follow-up period were offered to enter a re-treatment extension period with cadazolid (10 day of cadazolid + 30-day follow up)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '326'}]}, {'type': 'COMPLETED', 'comment': 'Include subjects who completed the main study + subjects who completed the re-treatment extension.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '296'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'randomized before giving IC', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '904 patients at 70 sites in 12 countries were screened, among whom 632 were enrolled in the IMPACT 1 trial at 64 sites located in North \\& South America, Europe and Australia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '620', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-64 years', 'categories': [{'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}, {'title': '65-74 years', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': '75 years and older', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '587', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CDAD episode type strata', 'classes': [{'title': 'First occurrence', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '253', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}]}]}, {'title': 'First recurrence', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "CDAD episode type strata was defined as baseline stratification factor 'First occurrence' or 'First recurrence' of CDAD as recorded in the Interactive voice recognition system (IVRS) at the time of subject randomization. Number of subjects with first recurrence or first occurrence at randomization was assessed for each treatment group.", 'unitOfMeasure': 'Participants'}, {'title': 'Initial strain of Clostridium difficile', 'classes': [{'title': 'Hypervirulent strains', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'Non-hypervirulent strains', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}]}, {'title': 'Unable to determine', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The strain of C. difficile at baseline was identified in the last stool sample collected up to treatment start date and with available C. difficile culture. Identification was done by polymerase chain reaction (PCR). The strains were categorized as hypervirulent strains (PCR ribotype 027, 078 or 244) or non-hypervirulent (other PCR ribotypes). The number of subjects with hypervirulent, non-hypervirulent strains at baseline was assessed for each treatment group. If PCR ribotype at baseline was not available, the subjects were classified as "unable to determine".', 'unitOfMeasure': 'Participants'}, {'title': 'CDAD severity at baseline', 'classes': [{'title': 'Mild-Moderate', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Unable to determine', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CDAD at baseline was considered as severe if the following criteria were met: maximum body temperature \\> 38.5 C, white blood cell counts \\> 15.0 x 10\\*9/L and rise in baseline serum creatinine \\> 50% compared to the level before CDAD diagnosis. Otherwise, it was considered as mild-moderate. The number of subjects with severe and mild-moderate CDAD at baseline was assessed for each treatment group. If any of the measurements required for derivation of severity was missing, the subjects were classified as "unable to determine".', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline characteristics were defined using the modified intent-to-treat analysis set (mITT) including all randomized subjects who have received at least one dose of the study drug and had a confirmed diagnosis of CDAD'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-22', 'size': 3202515, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-22T11:04', 'hasProtocol': True}, {'date': '2017-05-19', 'size': 3153502, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-23T10:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 632}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2013-11-07', 'resultsFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2013-11-13', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-03', 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population", 'timeFrame': 'Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)', 'description': "ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below."}, {'measure': "Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population", 'timeFrame': 'Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)', 'description': "ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below."}, {'measure': "Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5", 'timeFrame': 'Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)', 'description': "ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis.\n\nISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT)."}, {'measure': 'Sustained Cure Rate (SCR) in the Per-protocol Population', 'timeFrame': 'Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)', 'description': 'Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.'}, {'measure': 'Recurrence Rate', 'timeFrame': 'Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)', 'description': 'Recurrence is defined as the occurrence of a new episode of diarrhea (\\> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.'}], 'primaryOutcomes': [{'measure': 'Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population', 'timeFrame': 'Up to Day 12 on average (end-of-treatment + 2 days)', 'description': 'Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT.\n\nCCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.'}, {'measure': 'Clinical Cure Rate (CCR) in the Per-protocol Population', 'timeFrame': 'Up to Day 12 on average (end-of-treatment + 2 days)', 'description': 'Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.'}], 'secondaryOutcomes': [{'measure': 'Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population', 'timeFrame': 'Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)', 'description': 'Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).'}, {'measure': 'Kaplan-Meier Estimates for Resolution of Diarrhea', 'timeFrame': 'Up to Day 10', 'description': 'Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment.\n\nThe Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point.'}, {'measure': 'Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores', 'timeFrame': 'Day 1 (baseline) and Day 3', 'description': 'CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms. The least squares means (LSM) are computed on the scores.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-antibiotic diarrhea', 'Clostridium difficile infection'], 'conditions': ['Clostridium Difficile Infection']}, 'referencesModule': {'references': [{'pmid': '30709665', 'type': 'DERIVED', 'citation': 'Gerding DN, Cornely OA, Grill S, Kracker H, Marrast AC, Nord CE, Talbot GH, Buitrago M, Gheorghe Diaconescu I, Murta de Oliveira C, Preotescu L, Pullman J, Louie TJ, Wilcox MH. Cadazolid for the treatment of Clostridium difficile infection: results of two double-blind, placebo-controlled, non-inferiority, randomised phase 3 trials. Lancet Infect Dis. 2019 Mar;19(3):265-274. doi: 10.1016/S1473-3099(18)30614-5. Epub 2019 Jan 29.'}, {'pmid': '29680101', 'type': 'DERIVED', 'citation': 'Kleinman L, Talbot GH, Hunsche E, Schuler R, Nord CE. The CDI-DaySyms: Content Development of a New Patient-Reported Outcome Questionnaire for Symptoms of Clostridium difficile Infection. Value Health. 2018 Apr;21(4):441-448. doi: 10.1016/j.jval.2017.08.3017. Epub 2017 Nov 7.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).', 'detailedDescription': 'Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent.\n* Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.\n* Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with \\> 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.\n\nExclusion Criteria:\n\n* More than one previous episode of CDAD in the 3-month period prior to randomization.\n* Evidence of life-threatening or fulminant CDAD.\n* Likelihood of death within 72 hours from any cause.\n* History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.\n* Antimicrobial treatment active against CDAD administered for \\> 24 hours except for metronidazole treatment failures (MTF)\n* Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.\n* Unable or unwilling to comply with all protocol requirements.\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol'}, 'identificationModule': {'nctId': 'NCT01987895', 'briefTitle': 'Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)', 'orgStudyIdInfo': {'id': 'AC-061A301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cadazolid', 'description': 'Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days', 'interventionNames': ['Drug: Cadazolid', 'Drug: Vancomycin-matching placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days', 'interventionNames': ['Drug: Vancomycin', 'Drug: Cadazolid-matching placebo']}], 'interventions': [{'name': 'Cadazolid', 'type': 'DRUG', 'otherNames': ['ACT-179811'], 'description': 'Cadazolid 250 mg as oral suspension twice daily.', 'armGroupLabels': ['Cadazolid']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': 'Vancomycin 125 mg as oral capsules 4 times daily.', 'armGroupLabels': ['Vancomycin']}, {'name': 'Cadazolid-matching placebo', 'type': 'DRUG', 'description': 'Placebo matching cadazolid and administered orally twice daily', 'armGroupLabels': ['Vancomycin']}, {'name': 'Vancomycin-matching placebo', 'type': 'DRUG', 'description': 'Placebo capsules matching vancomycin and administered orally 4 times per day', 'armGroupLabels': ['Cadazolid']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anne Claire Marrast, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Actelion'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}