Viewing Study NCT00195351

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Ignite Creation Date: 2025-12-24 @ 11:55 PM
Ignite Modification Date: 2026-01-05 @ 2:44 AM
Study NCT ID: NCT00195351
Status: COMPLETED
Last Update Posted: 2013-02-25
First Post: 2005-09-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D004238', 'term': 'Diverticulitis'}, {'id': 'D010538', 'term': 'Peritonitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078304', 'term': 'Tigecycline'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintrialresults@wyeth.com', 'title': 'U. S. Contact Center', 'organization': 'Wyeth'}, 'certainAgreement': {'otherDetails': 'The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tigecycline', 'description': 'Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).', 'otherNumAffected': 195, 'seriousNumAffected': 51}, {'id': 'EG001', 'title': 'Ceftriaxone Sodium + Metronidazole', 'description': 'Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.', 'otherNumAffected': 189, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 64}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral moniliasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Healing abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoproteinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophophatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SGPT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary physical findings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocythemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Local reaction to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 14}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Taste perversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mesenteric fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retroperitoneal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Traumatic hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholestatic jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Melena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Carcinoma of the lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mesenteric venous occousion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Healing abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood urea nitrogen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocythemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'International normalized ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 231, 'numAffected': 0}], 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Patients with an indeterminate assessment were excluded.', 'anticipatedPostingDate': '2009-02'}, {'type': 'SECONDARY', 'title': 'Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tigecycline', 'description': 'Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).'}, {'id': 'OG001', 'title': 'Ceftriaxone Sodium + Metronidazole', 'description': 'Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '7.8', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-21 days after the last dose of test article', 'description': 'The clinical response was assigned by the investigator according to the protocol-specified guidelines. 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Patients with an indeterminate assessment were excluded.', 'anticipatedPostingDate': '2009-02'}, {'type': 'SECONDARY', 'title': 'Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tigecycline', 'description': 'Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).'}, {'id': 'OG001', 'title': 'Ceftriaxone Sodium + Metronidazole', 'description': 'Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.'}], 'classes': [{'title': 'Eradication and presumed eradication', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Persistence and presumed persistence', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Superinfection', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-13.9', 'ciUpperLimit': '8.1', 'statisticalMethod': 'Method of Mehrotra and Railkar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10-21 days after the last dose of test article', 'description': 'Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. 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[{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited worldwide from September 2005 to February 2008.', 'preAssignmentDetails': 'Subjects were screened up to two days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tigecycline', 'description': 'Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).'}, {'id': 'BG001', 'title': 'Ceftriaxone Sodium + Metronidazole', 'description': 'Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.17', 'spread': '18.05', 'groupId': 'BG000'}, {'value': '48.79', 'spread': '17.46', 'groupId': 'BG001'}, {'value': '48.48', 'spread': '17.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 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[{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 467}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2005-09-12', 'resultsFirstSubmitDate': '2009-02-27', 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A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.'}], 'secondaryOutcomes': [{'measure': 'Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.', 'timeFrame': '10-21 days after the last dose of test article', 'description': 'The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.'}, {'measure': 'Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.', 'timeFrame': '10-21 days after the last dose of test article', 'description': 'Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline \\& response was failure.'}]}, 'conditionsModule': {'keywords': ['Complicated intra-abdominal infection', 'Appendicitis with abscess', 'Perforated diverticulitis', 'Purulent peritonitis', 'Complicated cholecystitis'], 'conditions': ['Appendicitis', 'Cholecystitis', 'Cross Infection', 'Diverticulitis', 'Peritonitis']}, 'referencesModule': {'references': [{'pmid': '20670293', 'type': 'DERIVED', 'citation': 'Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score \\< 10 and \\> 10. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.\n* Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.\n\nExclusion Criteria:\n\n* Cancer\n* Medicines that suppress the immune system\n* Dialysis'}, 'identificationModule': {'nctId': 'NCT00195351', 'briefTitle': 'Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-abdominal Infection', 'orgStudyIdInfo': {'id': '3074A1-400'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: tigecycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: ceftriaxone sodium + metronidazole']}], 'interventions': [{'name': 'tigecycline', 'type': 'DRUG', 'description': 'every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)', 'armGroupLabels': ['A']}, {'name': 'ceftriaxone sodium + metronidazole', 'type': 'DRUG', 'description': 'Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. 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