Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-02-18 @ 2:47 AM
Study NCT ID:
NCT02070757
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Brazil', 'Canada', 'Colombia', 'Croatia', 'Czechia', 'Estonia', 'France', 'Georgia', 'Germany', 'Greece', 'Guatemala', 'Hungary', 'Ireland', 'Israel', 'Italy', 'Japan', 'Latvia', 'Lebanon', 'New Zealand', 'Philippines', 'Portugal', 'Russia', 'Serbia', 'Slovakia', 'South Africa', 'South Korea', 'Spain', 'Taiwan', 'Ukraine', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594038', 'term': 'ceftolozane, tazobactam drug combination'}, {'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': {'otherDetails': "Sponsor will review proposed publication within forty five (45) calendar days and reserves the right to defer such publication an additional forty five (45) calendar days to protect Sponsor's intellectual property as applicable. If a joint manuscript has not been submitted for publication within twelve (12) months of completion or termination of Trial at all participating sites, Principal Investigator is free to publish separately, subject to the other requirements of this Agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 35 days after last dose of study drug (Up to ~Day 50)', 'description': 'All safety analyses were based on a subset of the ITT population who received any amount (i.e., full or partial dose) of study drug (the Safety Population). All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population. Discontinuations due to adverse events (AEs) include deaths.', 'eventGroups': [{'id': 'EG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 361, 'otherNumAffected': 113, 'seriousNumAtRisk': 361, 'deathsNumAffected': 105, 'seriousNumAffected': 152}, {'id': 'EG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.', 'otherNumAtRisk': 359, 'deathsNumAtRisk': 359, 'otherNumAffected': 111, 'seriousNumAtRisk': 359, 'deathsNumAffected': 101, 'seriousNumAffected': 129}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 28, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 27, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 30, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebral arteriovenous malformation haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroduodenal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemorrhagic erosive gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hernial eventration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Brain death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatitis cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CNS ventriculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'Neurological decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Spinal cord oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acquired tracheo-oesophageal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mediastinal effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tracheal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neurogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '18.83', 'upperLimit': '27.39'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '19.96', 'upperLimit': '28.41'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-5.13', 'ciUpperLimit': '7.39', 'estimateComment': 'The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia \\[VABP\\] or ventilated hospital-acquired bacterial pneumonia \\[HABP\\]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000', 'lowerLimit': '49.47', 'upperLimit': '59.60'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '48.44', 'upperLimit': '58.54'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-6.17', 'ciUpperLimit': '8.29', 'estimateComment': 'The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.'}], 'paramType': 'NUMBER', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) at the TOC visit (7 to 14 days after the end-of-therapy \\[EOT\\] visit) using a non-inferiority margin of 12.5%. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '15.12', 'upperLimit': '24.50'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '18.89', 'upperLimit': '29.35'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-2.83', 'ciUpperLimit': '11.75', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'To compare the all cause mortality rates of participants in the ceftolozane/tazobactam versus meropenem arms in microbiological intent-to-treat (mITT) population.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was a subset of the ITT population that included any participant who received any amount of study drug and had at least 1 bacterial respiratory pathogen isolated from the baseline LRT culture that was susceptible to at least 1 of the study drugs.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '57.50', 'upperLimit': '70.11'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '58.83', 'upperLimit': '71.19'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-10.21', 'ciUpperLimit': '7.67', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To compare the clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with VNP (participants with either ventilator-associated bacterial pneumonia \\[VABP\\] or ventilated hospital-acquired bacterial pneumonia \\[HABP\\]) at the TOC visit in the CE population. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The CE population was a subset of the ITT population that included any participant who received study drug, adhered to the study protocol through the TOC visit, and had an evaluable clinical outcome (either Cure or Failure) at the TOC visit (or were classified as a clinical failure prior to the TOC visit).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.4', 'groupId': 'OG000', 'lowerLimit': '61.37', 'upperLimit': '77.55'}, {'value': '62.7', 'groupId': 'OG001', 'lowerLimit': '54.12', 'upperLimit': '71.24'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '-5.11', 'ciUpperLimit': '18.93', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To compare the per-participant microbiological response rates of ceftolozane/tazobactam versus meropenem at the TOC visit in the microbiologically evaluable (ME) population. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the TOC visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME population was a subset of the mITT population that included any participants who adhered to the study protocol through the TOC visit, had an evaluable clinical outcome (Cure or Failure) at the TOC visit and had at least 1 bacterial respiratory pathogen (at the appropriate CFU/mL threshold) isolated from the baseline LRT culture.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population (>=10 Isolates at Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'title': 'Gram-Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '60.91', 'upperLimit': '77.60'}, {'value': '62.4', 'groupId': 'OG001', 'lowerLimit': '53.35', 'upperLimit': '70.64'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '61.61', 'upperLimit': '90.15'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '39.71', 'upperLimit': '69.85'}]}]}, {'title': 'Enterobacteriaceae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.7', 'groupId': 'OG000', 'lowerLimit': '58.06', 'upperLimit': '77.64'}, {'value': '65.6', 'groupId': 'OG001', 'lowerLimit': '55.28', 'upperLimit': '74.55'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '58.10', 'upperLimit': '90.34'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '53.53', 'upperLimit': '87.45'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '56.43', 'upperLimit': '82.83'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '52.54', 'upperLimit': '78.32'}]}]}, {'title': 'Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '35.38', 'upperLimit': '84.83'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '39.68', 'upperLimit': '89.22'}]}]}, {'title': 'Haemophilus influenzae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '64.61', 'upperLimit': '98.51'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '21.52', 'upperLimit': '78.48'}]}]}, {'title': 'Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '25.05', 'upperLimit': '84.18'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '40.93', 'upperLimit': '92.85'}]}]}, {'title': 'Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '52.91', 'upperLimit': '97.76'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '25.05', 'upperLimit': '84.18'}]}]}, {'title': 'Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '11.76', 'upperLimit': '76.93'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '18.76', 'upperLimit': '81.24'}]}]}, {'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '9.68', 'upperLimit': '70.00'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '37.55', 'upperLimit': '96.38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To compare the percentage of participants with a microbiological outcome of eradication or presumed eradication, by pathogen. The microbiological outcome was classified as "eradication", "presumed eradication", "persistence", \'presumed persistence", "indeterminate" or "recurrence." "Eradication" was defined as a ≥1- log reduction in bacterial burden of the original baseline LRT pathogen AND a per pathogen count of ≤10\\^4 colony-forming unit (CFU)/mL for endotracheal aspirate (ETA) or sputum specimens, ≤10\\^3 CFU/mL for a bronchoalveolar lavage (BAL) specimen, or ≤10\\^2 CFU/mL for a protected brush specimen (PBS) from a follow-up LRT culture. Presumed eradication was defined as an absence of material to culture (e.g. inability to obtain a culture in an extubated patient) in a patient deemed a clinical cure.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME population included any participants in the mITT who adhered to the protocol, had an evaluable clinical outcome at TOC and at least 1 pathogen isolated from the baseline LRT culture at the appropriate CFU/mL threshold. The number analyzed per pathogen represents the number of participants in the ME population with that specific pathogen.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population - Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '10.48', 'upperLimit': '17.57'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '9.31', 'upperLimit': '15.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.41', 'ciUpperLimit': '3.57', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14', 'description': 'To compare the all cause mortality rates of participants (ceftolozane/tazobactam versus meropenem arms). Participants whose Day 14 mortality outcomes are missing or unknown are analysed as deceased.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '61.38', 'upperLimit': '71.03'}, {'value': '66.8', 'groupId': 'OG001', 'lowerLimit': '62.31', 'upperLimit': '71.77'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-7.67', 'ciUpperLimit': '6.04', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours after last dose of study drug (Up to ~Day 15)', 'description': 'To compare the clinical response rates at the EOT visit for ceftolozane/tazobactam versus meropenem. Clinical response at the EOT visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the End-of-Therapy (EOT) Visit in the Microbiologically Evaluable (ME) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000', 'lowerLimit': '71.51', 'upperLimit': '86.33'}, {'value': '78.8', 'groupId': 'OG001', 'lowerLimit': '70.25', 'upperLimit': '84.90'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-8.91', 'ciUpperLimit': '12.02', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours after last dose of study drug (Up to ~Day 15)', 'description': 'To compare the microbiological response rates of ceftolozane/tazobactam versus meropenem at the EOT visit. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the EOT visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME population was a subset of the mITT population that included any participants who adhered to the study protocol through the TOC visit, had an evaluable clinical outcome (Cure or Failure) at the TOC visit and had at least 1 bacterial respiratory pathogen (at the appropriate CFU/mL threshold) isolated from the baseline LRT culture.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response of Clinical Cure at the Late Follow-up (LFU) Visit in the Clinically Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '90.10', 'upperLimit': '97.99'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '85.86', 'upperLimit': '95.72'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.3', 'ciLowerLimit': '-3.38', 'ciUpperLimit': '10.44', 'estimateComment': 'The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.', 'groupDescription': 'Difference in Percentage of Participants', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (\\<65, \\>=65) categories.'}], 'paramType': 'NUMBER', 'timeFrame': '28 to 35 days after the last dose of study drug (Up to ~Day 50)', 'description': 'To compare the clinical response rates at the Late Follow-up (LFU) visit for ceftolozane/tazobactam versus meropenem in the CE population. Clinical response at the LFU visit will be classified as sustained cure, relapse, or indeterminate only in participants deemed a clinical cure at the TOC visit. A favorable clinical response is "sustained clinical cure."', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The CE population was a subset of the ITT population that included any participant who received study drug, adhered to the study protocol through the TOC visit, and had an evaluable clinical outcome (either Cure or Failure) at the TOC visit (or were classified as a clinical failure prior to the TOC visit).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Report 1 or More Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35 days after last dose of study drug (Up to ~Day 50)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety analyses were based on a subset of the ITT population (the Safety Population), which included randomized participants who received any amount (i.e., full or partial dose) of study drug. All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '35.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 35 days after last dose of study drug (Up to ~Day 50)', 'description': 'A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety analyses were based on a subset of the ITT population (the Safety Population), which included randomized participants who received any amount (i.e., full or partial dose) of study drug. All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after the first dose of study drug (Up to ~Day 15)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All safety analyses were based on a subset of the ITT population (the Safety Population), which included randomized participants who received any amount (i.e., full or partial dose) of study drug. All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'FG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '362'}, {'groupId': 'FG001', 'numSubjects': '364'}]}, {'type': 'Treated Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '114'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Discharged from Study Hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 263 sites were opened for enrollment with the majority of participants recruited from sites in eastern Europe.', 'preAssignmentDetails': 'Randomization was stratified by diagnosis (ventilator-associated bacterial pneumonia \\[VABP\\] or ventilated hospital-acquired bacterial pneumonia \\[HABP\\]) and by age (\\<65 or ≥65 years). All participants randomized were included in the intent-to-treat (ITT) population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '362', 'groupId': 'BG000'}, {'value': '364', 'groupId': 'BG001'}, {'value': '726', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ceftolozane/Tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam (comprising 2000 mg ceftolozane and 1000 mg tazobactam) administered as an IV infusion every 8 hours (q8h).'}, {'id': 'BG001', 'title': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem administered as an IV infusion q8h.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '16.7', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '17.2', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '16.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '517', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian Or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'American Indian Or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-28', 'size': 1035393, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-07T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2014-02-19', 'resultsFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-07', 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28', 'timeFrame': 'Day 28', 'description': 'To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia \\[VABP\\] or ventilated hospital-acquired bacterial pneumonia \\[HABP\\]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) at the TOC visit (7 to 14 days after the end-of-therapy \\[EOT\\] visit) using a non-inferiority margin of 12.5%. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.'}, {'measure': 'Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28', 'timeFrame': 'Day 28', 'description': 'To compare the all cause mortality rates of participants in the ceftolozane/tazobactam versus meropenem arms in microbiological intent-to-treat (mITT) population.'}, {'measure': 'Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To compare the clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with VNP (participants with either ventilator-associated bacterial pneumonia \\[VABP\\] or ventilated hospital-acquired bacterial pneumonia \\[HABP\\]) at the TOC visit in the CE population. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.'}, {'measure': 'Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To compare the per-participant microbiological response rates of ceftolozane/tazobactam versus meropenem at the TOC visit in the microbiologically evaluable (ME) population. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the TOC visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.'}, {'measure': 'Percentage of Participants With Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population (>=10 Isolates at Baseline)', 'timeFrame': '7 to 14 days after last dose of study drug (Up to ~Day 30)', 'description': 'To compare the percentage of participants with a microbiological outcome of eradication or presumed eradication, by pathogen. The microbiological outcome was classified as "eradication", "presumed eradication", "persistence", \'presumed persistence", "indeterminate" or "recurrence." "Eradication" was defined as a ≥1- log reduction in bacterial burden of the original baseline LRT pathogen AND a per pathogen count of ≤10\\^4 colony-forming unit (CFU)/mL for endotracheal aspirate (ETA) or sputum specimens, ≤10\\^3 CFU/mL for a bronchoalveolar lavage (BAL) specimen, or ≤10\\^2 CFU/mL for a protected brush specimen (PBS) from a follow-up LRT culture. Presumed eradication was defined as an absence of material to culture (e.g. inability to obtain a culture in an extubated patient) in a patient deemed a clinical cure.'}, {'measure': 'Percentage of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population - Day 14', 'timeFrame': 'Day 14', 'description': 'To compare the all cause mortality rates of participants (ceftolozane/tazobactam versus meropenem arms). Participants whose Day 14 mortality outcomes are missing or unknown are analysed as deceased.'}, {'measure': 'Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population', 'timeFrame': 'Within 24 hours after last dose of study drug (Up to ~Day 15)', 'description': 'To compare the clinical response rates at the EOT visit for ceftolozane/tazobactam versus meropenem. Clinical response at the EOT visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate.'}, {'measure': 'Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the End-of-Therapy (EOT) Visit in the Microbiologically Evaluable (ME) Population', 'timeFrame': 'Within 24 hours after last dose of study drug (Up to ~Day 15)', 'description': 'To compare the microbiological response rates of ceftolozane/tazobactam versus meropenem at the EOT visit. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the EOT visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.'}, {'measure': 'Percentage of Participants With Clinical Response of Clinical Cure at the Late Follow-up (LFU) Visit in the Clinically Evaluable (CE) Population', 'timeFrame': '28 to 35 days after the last dose of study drug (Up to ~Day 50)', 'description': 'To compare the clinical response rates at the Late Follow-up (LFU) visit for ceftolozane/tazobactam versus meropenem in the CE population. Clinical response at the LFU visit will be classified as sustained cure, relapse, or indeterminate only in participants deemed a clinical cure at the TOC visit. A favorable clinical response is "sustained clinical cure."'}, {'measure': 'Percentage of Participants Who Report 1 or More Adverse Event (AE)', 'timeFrame': 'Up to 35 days after last dose of study drug (Up to ~Day 50)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.'}, {'measure': 'Percentage of Participants With Any Serious Adverse Event (SAE)', 'timeFrame': 'Up to 35 days after last dose of study drug (Up to ~Day 50)', 'description': 'A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.'}, {'measure': 'Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE)', 'timeFrame': 'Up to 14 days after the first dose of study drug (Up to ~Day 15)', 'description': 'An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthcare-Associated Pneumonia', 'Ventilator-Associated Pneumonia', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '26096377', 'type': 'RESULT', 'citation': 'Xiao AJ, Miller BW, Huntington JA, Nicolau DP. Ceftolozane/tazobactam pharmacokinetic/pharmacodynamic-derived dose justification for phase 3 studies in patients with nosocomial pneumonia. J Clin Pharmacol. 2016 Jan;56(1):56-66. doi: 10.1002/jcph.566. Epub 2015 Aug 25.'}, {'pmid': '36773112', 'type': 'DERIVED', 'citation': 'Martin-Loeches I, Shorr AF, Wunderink RG, Kollef MH, Timsit JF, Yu B, Huntington JA, Jensen E, Bruno CJ. Outcomes in participants with ventilated nosocomial pneumonia and organ failure treated with ceftolozane/tazobactam versus meropenem: a subset analysis of the phase 3, randomized, controlled ASPECT-NP trial. Ann Intensive Care. 2023 Feb 11;13(1):8. doi: 10.1186/s13613-022-01084-8.'}, {'pmid': '36457059', 'type': 'DERIVED', 'citation': 'Kollef MH, Timsit JF, Martin-Loeches I, Wunderink RG, Huntington JA, Jensen EH, Yu B, Bruno CJ. Outcomes in participants with failure of initial antibacterial therapy for hospital-acquired/ventilator-associated bacterial pneumonia prior to enrollment in the randomized, controlled phase 3 ASPECT-NP trial of ceftolozane/tazobactam versus meropenem. Crit Care. 2022 Dec 1;26(1):373. doi: 10.1186/s13054-022-04192-w.'}, {'pmid': '35781341', 'type': 'DERIVED', 'citation': 'Paterson DL, Bassetti M, Motyl M, Johnson MG, Castanheira M, Jensen EH, Huntington JA, Yu B, Wolf DJ, Bruno CJ. Ceftolozane/tazobactam for hospital-acquired/ventilator-associated bacterial pneumonia due to ESBL-producing Enterobacterales: a subgroup analysis of the ASPECT-NP clinical trial. J Antimicrob Chemother. 2022 Aug 25;77(9):2522-2531. doi: 10.1093/jac/dkac184.'}, {'pmid': '34600585', 'type': 'DERIVED', 'citation': 'Shorr AF, Bruno CJ, Zhang Z, Jensen E, Gao W, Feng HP, Huntington JA, Yu B, Rhee EG, De Anda C, Basu S, Kollef MH. Ceftolozane/tazobactam probability of target attainment and outcomes in participants with augmented renal clearance from the randomized phase 3 ASPECT-NP trial. Crit Care. 2021 Oct 2;25(1):354. doi: 10.1186/s13054-021-03773-5.'}, {'pmid': '34380538', 'type': 'DERIVED', 'citation': 'Timsit JF, Huntington JA, Wunderink RG, Shime N, Kollef MH, Kivistik U, Novacek M, Rea-Neto A, Martin-Loeches I, Yu B, Jensen EH, Butterton JR, Wolf DJ, Rhee EG, Bruno CJ. Ceftolozane/tazobactam versus meropenem in patients with ventilated hospital-acquired bacterial pneumonia: subset analysis of the ASPECT-NP randomized, controlled phase 3 trial. Crit Care. 2021 Aug 11;25(1):290. doi: 10.1186/s13054-021-03694-3.'}, {'pmid': '33318005', 'type': 'DERIVED', 'citation': 'Castanheira M, Johnson MG, Yu B, Huntington JA, Carmelitano P, Bruno C, Rhee EG, Motyl M. Molecular Characterization of Baseline Enterobacterales and Pseudomonas aeruginosa Isolates from a Phase 3 Nosocomial Pneumonia (ASPECT-NP) Clinical Trial. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e02461-20. doi: 10.1128/AAC.02461-20. Print 2021 Feb 17.'}, {'pmid': '32996064', 'type': 'DERIVED', 'citation': 'Lodise T, Yang J, Puzniak LA, Dillon R, Kollef M. Healthcare Resource Utilization of Ceftolozane/Tazobactam Versus Meropenem for Ventilated Nosocomial Pneumonia from the Randomized, Controlled, Double-Blind ASPECT-NP Trial. Infect Dis Ther. 2020 Dec;9(4):953-966. doi: 10.1007/s40121-020-00343-0. Epub 2020 Sep 30.'}, {'pmid': '32988827', 'type': 'DERIVED', 'citation': 'Huntington JA, Yu B, Li L, Jensen E, Bruno C, Boakye M, Zhang Z, Gao W, Feng HP, Rhee E. Outcomes in Participants with Renal Impairment from a Phase 3 Clinical Trial for Ceftolozane/Tazobactam Treatment of Nosocomial Pneumonia (ASPECT-NP). Antimicrob Agents Chemother. 2020 Nov 17;64(12):e00731-20. doi: 10.1128/AAC.00731-20. Print 2020 Nov 17.'}, {'pmid': '31563344', 'type': 'DERIVED', 'citation': 'Kollef MH, Novacek M, Kivistik U, Rea-Neto A, Shime N, Martin-Loeches I, Timsit JF, Wunderink RG, Bruno CJ, Huntington JA, Lin G, Yu B, Butterton JR, Rhee EG. Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2019 Dec;19(12):1299-1311. doi: 10.1016/S1473-3099(19)30403-7. Epub 2019 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 3, multicenter, prospective, randomized study of intravenous (IV) ceftolozane/tazobactam versus IV meropenem in the treatment of adult participants with either ventilator-associated bacterial pneumonia (VABP) or ventilated hospital-acquired bacterial pneumonia (HABP). The primary objective is to demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) based on the difference in Day 28 all-cause mortality rates in the Intent-to-treat (ITT) population using a non-inferiority margin of 10%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Adult participants diagnosed with either VABP or ventilated HABP requiring IV antibiotic therapy;\n* Intubated and on mechanical ventilation at the time of randomization;\n* New or progressive infiltrate on chest radiography consistent with pneumonia;\n* Presence of clinical criteria consistent with a diagnosis of ventilated nosocomial pneumonia.\n\nKey Exclusion Criteria:\n\n* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;\n* Prior non-study antibiotics for \\> 24 hours;\n* Gram stain of lower respiratory tract specimen showing only gram positive bacteria;\n* Active immunosuppression;\n* End-stage renal disease or requirement for dialysis;\n* Expected survival \\< 72 hours;\n* Severe confounding respiratory condition (i.e., chest trauma with paradoxical respiration);\n* Known or suspected community-acquired bacterial pneumonia.\n* Anticipated concomitant use of any of the following medications during the course of study therapy: valproic acid or divalproex sodium. Anticipated concomitant use of serotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptor agonists (triptans), meperidine, or buspirone during the course of linezolid treatment.\n* Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose of study drug or anticipated concomitant use during the course of linezolid therapy.'}, 'identificationModule': {'nctId': 'NCT02070757', 'acronym': 'ASPECT-NP', 'briefTitle': 'Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/Tazobactam Compared With Meropenem in Adult Patients With Ventilated Nosocomial Pneumonia', 'orgStudyIdInfo': {'id': '7625A-008'}, 'secondaryIdInfos': [{'id': 'CXA-NP-11-04', 'type': 'OTHER', 'domain': 'Cubist Protocol Number'}, {'id': '163338', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}, {'id': 'MK-7625A-008', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceftolozane/tazobactam', 'description': 'Participants receive 3000 mg ceftolozane/tazobactam intravenous IV (comprising 2000 mg ceftolozane and 1000 mg tazobactam) every 8 hours for 8-14 days.', 'interventionNames': ['Drug: Ceftolozane/tazobactam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meropenem', 'description': 'Participants receive 1000 mg meropenem IV every 8 hours for 8-14 days.', 'interventionNames': ['Drug: Meropenem']}], 'interventions': [{'name': 'Ceftolozane/tazobactam', 'type': 'DRUG', 'description': 'Ceftolozane/tazobactam is an antibacterial consisting of a co-formulation of ceftolozane, a novel antipseudomonal cephalosporin and tazobactam, a well-established beta (β)-lactamase inhibitor (BLI) being developed for the treatment of serious bacterial infections.', 'armGroupLabels': ['Ceftolozane/tazobactam']}, {'name': 'Meropenem', 'type': 'DRUG', 'otherNames': ['MERREM® IV'], 'description': 'Meropenem is a broad spectrum injectable antibiotic widely used to treat serious infections such as ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia.', 'armGroupLabels': ['Meropenem']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}