Viewing Study NCT00314951

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Ignite Creation Date: 2025-12-24 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
Study NCT ID: NCT00314951
Status: COMPLETED
Last Update Posted: 2017-04-21
First Post: 2006-04-13
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077732', 'term': 'Fidaxomicin'}, {'id': 'C487655', 'term': 'OPT 80'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Informed consent to 7-days following the last dose of study drug or until the last protocol-specified study visit, whichever occured later.', 'eventGroups': [{'id': 'EG000', 'title': 'Vancomycin', 'description': '125 mg administered 4 times daily (q6hr)', 'otherNumAtRisk': 323, 'otherNumAffected': 195, 'seriousNumAtRisk': 323, 'seriousNumAffected': 78}, {'id': 'EG001', 'title': 'Fidaxomicin', 'description': '200 mg administered twice daily (q12hr)', 'otherNumAtRisk': 300, 'otherNumAffected': 187, 'seriousNumAtRisk': 300, 'seriousNumAffected': 75}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 13}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 16}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cleft palate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inguinal hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Endocarditis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyelocystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fungaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sepsis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Shunt infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Graft haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood calcium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood phosphorus abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood urea abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blood uric acid abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Adrenal gland cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intra-uterine death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemopneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 323, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 300, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cure Rate at End of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': '125 mg administered 4 times daily (q6hr)'}, {'id': 'OG001', 'title': 'Fidaxomicin', 'description': '200 mg administered twice daily (q12hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '89.2'}, {'value': '88.2', 'groupId': 'OG001', 'lowerLimit': '84.0', 'upperLimit': '91.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '8.0', 'groupDescription': 'H0: C(fidaxomicin) - C(Vancomycin) \\<= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.'}], 'paramType': 'NUMBER', 'timeFrame': 'Study day 10 (+/- 2 days)', 'description': 'Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis data is modified intent to treat (mITT) population. The mITT population consists of subjects that had CDAD confirmed by \\>3 unformed bowel movements in the 24 hours prior to randomization and a positive toxin assay and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': '125 mg administered 4 times daily (q6hr)'}, {'id': 'OG001', 'title': 'Fidaxomicin', 'description': '200 mg administered twice daily (q12hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.4', 'ciLowerLimit': '-16.2', 'ciUpperLimit': '-2.5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Study days 11-40', 'description': 'Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population for subjects who met the primary endpoint of cure subjects, were analyzed for the recurrence rates of diarrhea up to the Poststudy Visit.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Global Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': '125 mg administered 4 times daily (q6hr)'}, {'id': 'OG001', 'title': 'Fidaxomicin', 'description': '200 mg administered twice daily (q12hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.2', 'ciLowerLimit': '2.8', 'ciUpperLimit': '17.5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (Day 40)', 'description': "Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is mITT, subjects that achieved a cure response at end of treatment and not having a recurrence at any time up to the Post-study visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vancomycin', 'description': '125 mg administered 4 times daily (q6hr)'}, {'id': 'FG001', 'title': 'Fidaxomicin', 'description': '200 mg administered twice daily (q12hr)'}], 'periods': [{'title': 'Enrollment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '306'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "6 subjects took incorrect treatment assignment, 6 subjects didn't take drug", 'groupId': 'FG000', 'numSubjects': '323'}, {'comment': "6 subjects took incorrect treatment assignment, 6 subjects didn't take drug", 'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '289'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': "Didn't meet criteria for mITT population", 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '289'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '255'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'mITT failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '34'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from May 2006 to August 2008 by centers in the United States and Canada.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vancomycin', 'description': '125 mg administered 4 times daily (q6hr)'}, {'id': 'BG001', 'title': 'Fidaxomicin', 'description': '200 mg administered twice daily (q12hr)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '60.3', 'spread': '16.9', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '16.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 629}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2010-08-27', 'completionDateStruct': {'date': '2008-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2006-04-13', 'dispFirstSubmitQcDate': '2010-08-27', 'resultsFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2006-04-13', 'dispFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-16', 'studyFirstPostDateStruct': {'date': '2006-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Global Cure', 'timeFrame': 'End of Study (Day 40)', 'description': "Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40."}], 'primaryOutcomes': [{'measure': 'Cure Rate at End of Therapy', 'timeFrame': 'Study day 10 (+/- 2 days)', 'description': 'Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.'}], 'secondaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': 'Study days 11-40', 'description': 'Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CDAD, Clostridium difficile, diarrhea', 'Clostridium difficile-Associated Diarrhea'], 'conditions': ['Clostridium Infections', 'Diarrhea']}, 'referencesModule': {'references': [{'pmid': '21288078', 'type': 'RESULT', 'citation': 'Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, Gorbach S, Sears P, Shue YK; OPT-80-003 Clinical Study Group. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011 Feb 3;364(5):422-31. doi: 10.1056/NEJMoa0910812.'}, {'pmid': '24599770', 'type': 'DERIVED', 'citation': "D'Agostino RB Sr, Collins SH, Pencina KM, Kean Y, Gorbach S. Risk estimation for recurrent Clostridium difficile infection based on clinical factors. Clin Infect Dis. 2014 May;58(10):1386-93. doi: 10.1093/cid/ciu107. Epub 2014 Mar 5."}, {'pmid': '23715579', 'type': 'DERIVED', 'citation': 'Cornely OA, Miller MA, Fantin B, Mullane K, Kean Y, Gorbach S. Resolution of Clostridium difficile-associated diarrhea in patients with cancer treated with fidaxomicin or vancomycin. J Clin Oncol. 2013 Jul 1;31(19):2493-9. doi: 10.1200/JCO.2012.45.5899. Epub 2013 May 28.'}, {'pmid': '22752865', 'type': 'DERIVED', 'citation': 'Cornely OA, Miller MA, Louie TJ, Crook DW, Gorbach SL. Treatment of first recurrence of Clostridium difficile infection: fidaxomicin versus vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S154-61. doi: 10.1093/cid/cis462.'}, {'pmid': '22752862', 'type': 'DERIVED', 'citation': 'Louie TJ, Cannon K, Byrne B, Emery J, Ward L, Eyben M, Krulicki W. Fidaxomicin preserves the intestinal microbiome during and after treatment of Clostridium difficile infection (CDI) and reduces both toxin reexpression and recurrence of CDI. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S132-42. doi: 10.1093/cid/cis338.'}, {'pmid': '22752860', 'type': 'DERIVED', 'citation': 'Nerandzic MM, Mullane K, Miller MA, Babakhani F, Donskey CJ. Reduced acquisition and overgrowth of vancomycin-resistant enterococci and Candida species in patients treated with fidaxomicin versus vancomycin for Clostridium difficile infection. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S121-6. doi: 10.1093/cid/cis440.'}, {'pmid': '22752857', 'type': 'DERIVED', 'citation': 'Figueroa I, Johnson S, Sambol SP, Goldstein EJ, Citron DM, Gerding DN. Relapse versus reinfection: recurrent Clostridium difficile infection following treatment with fidaxomicin or vancomycin. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S104-9. doi: 10.1093/cid/cis357.'}]}, 'descriptionModule': {'briefSummary': 'This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).', 'detailedDescription': 'The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males/females with CDAD\n* Females must use adequate contraception\n* Signed informed consent\n\nExclusion Criteria:\n\n* Life-threatening CDAD\n* Toxic megacolon\n* Pregnant\n* Concurrent use of diarrheal agents\n* Participation in other trials'}, 'identificationModule': {'nctId': 'NCT00314951', 'briefTitle': 'Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea', 'orgStudyIdInfo': {'id': '5119-018'}, 'secondaryIdInfos': [{'id': '101.1.C.003', 'type': 'OTHER', 'domain': 'Optimerpharma Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fidaxomicin', 'description': 'Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \\[q12h\\] regimen) with intermittent matching placebo to fidaxomicin', 'interventionNames': ['Drug: Fidaxomicin', 'Drug: Matching Placebo to Fidaxomicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \\[q6h\\] regimen).', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Fidaxomicin', 'type': 'DRUG', 'otherNames': ['PAR-101', 'OPT-80', 'Dificid®'], 'description': '200 mg oral capsules two times daily (q12h regimen)', 'armGroupLabels': ['fidaxomicin']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': '125 mg capsules q6hr (4 times a day)', 'armGroupLabels': ['Vancomycin']}, {'name': 'Matching Placebo to Fidaxomicin', 'type': 'DRUG', 'description': 'Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)', 'armGroupLabels': ['fidaxomicin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}