Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-24 @ 12:25 AM
Study NCT ID:
NCT03329092
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'Hungary', 'Peru', 'South Africa', 'Vietnam'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: From signing of informed consent until end of late follow up visit (Day 45); non-SAEs and SAEs: From start of study treatment until end of late follow-up visit (Up to Day 45).', 'description': 'All-cause mortality is presented for ITT analysis set and non-SAEs and SAEs are presented for Safety analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.', 'otherNumAtRisk': 275, 'deathsNumAtRisk': 282, 'otherNumAffected': 113, 'seriousNumAtRisk': 275, 'deathsNumAffected': 20, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion.", 'otherNumAtRisk': 137, 'deathsNumAtRisk': 140, 'otherNumAffected': 45, 'seriousNumAtRisk': 137, 'deathsNumAffected': 11, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'seriousEvents': [{'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myxomatous mitral valve degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Intra-abdominal fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal wall infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Central nervous system infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Chronic hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Device related bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fat embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Intestinal anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Adenocarcinoma of appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Brain dislocation syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Pleural 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{'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Convalescent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Intent-To-Treat (ITT) Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000', 'lowerLimit': '62.8', 'upperLimit': '73.7'}, {'value': '65.7', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '73.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '12.4', 'estimateComment': 'The confidence interval (CI) for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% confidence interval (CI) was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all randomized participants regardless of receipt of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Cure at TOC Visit: Clinically Evaluable (CE) Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '82.3'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '81.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '13.2', 'estimateComment': 'The CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on CE analysis set.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at TOC Visit: Microbiological Intent-To-Treat (Micro-ITT) Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '79.0'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '62.7', 'upperLimit': '80.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '12.1', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The microbiological Intent-To-Treat (micro-ITT) analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at TOC Visit: Microbiologically Evaluable (ME) Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '84.5'}, {'value': '75.9', 'groupId': 'OG001', 'lowerLimit': '65.7', 'upperLimit': '84.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '14.7', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'cIAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '81.8'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '65.0', 'upperLimit': '81.7'}]}]}, {'title': 'HAP/VAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '57.3'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '57.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '13.0', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'cIAI', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '23.1', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'HAP/VAP', 'statisticalMethod': 'Difference', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants regardless of receipt of study drug. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'cIAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '89.9'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '69.9', 'upperLimit': '87.1'}]}]}, {'title': 'HAP/VAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '61.1'}, {'value': '54.5', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '73.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '16.6', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'cIAI', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-31.9', 'ciUpperLimit': '17.3', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'HAP/VAP', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "CE analysis set. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure in Participants With Metallo-beta-lactamase (MBL) Positive Pathogen at TOC Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set was a subset of the ITT analysis and included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure in Participants With MBL Positive Pathogen at TOC Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit: Micro- ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000'}, {'value': '73.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit day (28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set was a subset of the ITT analysis sets and included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. Participants with a per participant response of indeterminate were excluded from this analysis. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000'}, {'value': '75.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC Visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died on or Before 28 Days After Randomization: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 28 days', 'description': 'Percentage of participants who died on or before 28 days after randomization is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all randomized participants regardless of receipt of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Died on or Before 28 Days After Randomization: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 28 days', 'description': 'Percentage of participants who died on or before 28 days after randomization is reported in this outcome measure.', 'unitOfMeasure': 'Percenatge of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}], 'classes': [{'title': 'Renal Function: Augmented:25 to 30 minutes post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.3', 'spread': '339.08', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented:3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.99', 'spread': '287.36', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 5.5 hours to 6.5 hours post loading infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.11', 'spread': '338.5', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 25 to 30 min post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.85', 'spread': '234.46', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild:3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.24', 'spread': '222.32', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild:5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.03', 'spread': '115.83', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild:7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.62', 'spread': '54.42', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 25 to 30 min post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.49', 'spread': '313.99', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.72', 'spread': '259.64', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.45', 'spread': '139.9', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 25 to 30 min post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.98', 'spread': '187.86', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.31', 'spread': '30.13', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.54', 'spread': '46.87', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.42', 'spread': '34.88', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.11', 'spread': '234.31', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.56', 'spread': '204.99', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.56', 'spread': '205.84', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.59', 'spread': '404.54', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.69', 'spread': '422.52', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.75', 'spread': '271.62', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.98', 'spread': '62.54', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.33', 'spread': '183.2', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58', 'spread': '129.36', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.72', 'spread': '59.15', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.91', 'spread': '45.17', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.17', 'spread': '34.89', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.11', 'spread': '57.13', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe:7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.69', 'spread': '55.56', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4', 'description': 'Plasma concentration for aztreonam according to renal function (augmented, normal and mild, moderate and severe is presented in this outcome measure. Augmented = Creatinine clearance (CrCL) \\> 150 milliliters per minute (mL/min); Normal \\& Mild = CrCL \\> 50 to \\<=150 mL/min; Moderate = CrCL \\> 30 to ≤ 50 mL/min; Severe = CrCL \\> 15 to ≤ 30 mL/min.', 'unitOfMeasure': 'Milligram/Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who had at least 1 plasma concentration data assessment available for ATM or AVI. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}], 'classes': [{'title': 'Renal Function: Augmented:25 to 30 minutes post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.77', 'spread': '353.86', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented:3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '299.27', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.75', 'spread': '366.33', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented:7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 25 to 30 min post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.81', 'spread': '338.73', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild:3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.76', 'spread': '242.67', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild:5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.85', 'spread': '209.49', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild:7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.18', 'spread': '62.62', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 25 to 30 min post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.56', 'spread': '383.79', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.28', 'spread': '262.6', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.47', 'spread': '160.75', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.91', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 25 to 30 min post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.11', 'spread': '202.08', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 3.25 to 3.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.62', 'spread': '39.68', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 5.5 hours to 6.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '54.34', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 7.5 to 8.5 hours post start of infusion on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'spread': '57.91', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.75', 'spread': '289.96', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.23', 'spread': '263.94', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.19', 'spread': '265.65', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Augmented: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.72', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.46', 'spread': '504.77', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.29', 'spread': '493.48', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.48', 'spread': '382.3', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Normal & Mild: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.19', 'spread': '51.22', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.98', 'spread': '208.63', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.86', 'spread': '156.96', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.23', 'spread': '72.89', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Moderate: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.35', 'spread': 'NA', 'comment': 'Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 2.75 to 3 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.35', 'spread': '44.72', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 3.5 to 4.5 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.68', 'spread': '42.15', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: 5 to 6 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.99', 'spread': '67.87', 'groupId': 'OG000'}]}]}, {'title': 'Renal Function: Severe: Moderate: 7 to 8 hours post start of infusion on Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.97', 'spread': '47.28', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4', 'description': 'Plasma concentration for avibactam according to renal function (augmented, normal and mild, moderate and severe is presented in this outcome measure. Augmented = CrCL \\> 150 mL/min; Normal \\& Mild = CrCL \\> 50 to \\<=150 mL/min; Moderate = CrCL \\> 30 to ≤ 50 mL/min; Severe = CrCL \\> 15 to ≤ 30 mL/min.', 'unitOfMeasure': 'Milligram/Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK analysis set included all participants who had at least 1 plasma concentration data assessment available for ATM or AVI. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration for a Dosing Interval at Steady-State (Cmax, ss) According to Clinical Response by Infection Type at TOC: Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.47', 'spread': '37.49', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.71', 'spread': '62.52', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.21', 'spread': '12.7', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.24', 'spread': '48.49', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.57', 'spread': '33.97', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.79', 'spread': '27.2', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.89', 'spread': '30.42', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.5', 'spread': '31.1', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.34', 'spread': 'NA', 'comment': 'Standard deviation (SD) was not estimated because of less number of participants in this event.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted maximum plasma concentration for a dosing interval at steady-state (Cmax,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram per liter (mg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Percentage of Time That Free Plasma Concentrations Are Above the Minimum Inhibitory Concentration Over a Dosing Interval (%fT>MIC Aztreonam (ATM) of 8 mg/L) According to Clinical Response by Infection Type at TOC: Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.4', 'spread': '41.9', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.81', 'spread': '134.39', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.87', 'spread': '7.67', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.2', 'spread': '8.4', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.29', 'spread': '8.94', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.38', 'spread': '10.02', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>MIC ATM of 8 mg/L) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss ) According to Clinical Response by Infection Type at TOC: Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '816.18', 'spread': '41.83', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '877.5', 'spread': '85.91', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1069.1', 'spread': '15.82', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1420.1', 'spread': '54.62', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1079.4', 'spread': '34.1', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1056.8', 'spread': '35.68', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '858.39', 'spread': '32.49', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '912.23', 'spread': '38.1', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1084.6', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 24 hours at TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram*hours per liter (mg*h/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss) According to Microbiological Response by Infection Type at TOC: Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.26', 'spread': '34.03', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.71', 'spread': '67.14', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.97', 'spread': '9.49', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.9', 'spread': '71.56', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.48', 'spread': '38.83', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.2', 'spread': '33.87', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.71', 'spread': '37.56', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.77', 'spread': '31.52', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.34', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (Cmax,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram per liter (mg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Number Analyzed=participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Microbiological Response by Infection Type at TOC: Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '830.23', 'spread': '38.42', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '826.63', 'spread': '95.22', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1010.2', 'spread': '9.17', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1446.1', 'spread': '82.6', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '909.59', 'spread': '45.06', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1237.9', 'spread': '38.16', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '760.26', 'spread': '40.54', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '974.21', 'spread': '37.82', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1084.6', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 24 hours at TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram*hours per liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Percentage of Time That Free Plasma Concentrations Are Above the Minimum Inhibitory Concentration Over a Dosing Interval (%fT>MIC Aztreonam (ATM) of 8 mg/L) According to Microbiological Response by Infection Type at TOC: Aztreonam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.57', 'spread': '17.66', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.02', 'spread': '171.87', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.53', 'spread': '11.05', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.9', 'spread': '14.14', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.8', 'spread': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.42', 'spread': '9.54', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>MIC ATM of 8 mg/L) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Clinical Response by Infection Type at TOC: Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '164.92', 'spread': '45.91', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '187.41', 'spread': '96.93', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '213.92', 'spread': '20.81', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '291.47', 'spread': '61.75', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '214.99', 'spread': '36.09', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '257.37', 'spread': '71.75', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '176.95', 'spread': '31.43', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '178.68', 'spread': '38.99', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '218.09', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 24 hours at TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram*hour per liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss ) According to Clinical Response by Infection Type at TOC: Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.01', 'spread': '42.14', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.48', 'spread': '72.59', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.04', 'spread': '16.52', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.41', 'spread': '55.07', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.46', 'spread': '33.52', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.24', 'spread': '49.1', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.64', 'spread': '31.01', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.44', 'spread': '32.65', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.93', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (Cmax,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram per liter (mg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Percent of Time That Free Plasma Concentrations Are Above the Threshold Concentration Over a Dosing Interval (%fT>CT of 2.5mg/L) According to Clinical Response by Infection Type at TOC: Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.53', 'spread': '43.26', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.92', 'spread': '133.68', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.52', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Clinical cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.99', 'spread': '11.57', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.28', 'spread': '12.12', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.75', 'spread': '11.19', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92', 'spread': '13.01', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.08', 'spread': '12.93', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>CT of 2.5mg/L) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Microbiological Response by Infection Type at TOC: Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.4', 'spread': '40.88', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '177.65', 'spread': '106.25', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '197.01', 'spread': '7.31', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '293.49', 'spread': '95.13', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '196.38', 'spread': '61.95', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '359.31', 'spread': '71.12', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '157.79', 'spread': '43.71', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '192.85', 'spread': '38.42', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '218.09', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 to 24 hours At TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving\\<48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram*hours per liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss (mg/L)) According to Microbiological Response by Infection Type at TOC: Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam- Avibactam', 'description': 'Participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '37.2', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.83', 'spread': '76.48', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.03', 'spread': '8.01', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.55', 'spread': '84.68', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.31', 'spread': '51.34', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.72', 'spread': '55.03', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.75', 'spread': '42.72', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.28', 'spread': '32.85', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.93', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (Cmax,ss (mg/L)) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving\\<48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Milligram per liter (mg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Percent of Time That Free Plasma Concentrations Are Above the Threshold Concentration Over a Dosing Interval; (%fT>CT of 2.5 mg/L) According to Microbiological Response by Infection Type at TOC: Avibactam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Avibactam', 'description': 'Participants who received AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044) were included in the analysis.'}], 'classes': [{'title': 'cIAI: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.93', 'spread': '21.78', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.43', 'spread': '170.59', 'groupId': 'OG000'}]}]}, {'title': 'cIAI: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.24', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': 'HAP:Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.26', 'spread': '16.44', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.03', 'spread': '18.83', 'groupId': 'OG000'}]}]}, {'title': 'HAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Favorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.47', 'spread': '16.8', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Unfavorable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.52', 'spread': '11.79', 'groupId': 'OG000'}]}]}, {'title': 'VAP: Indeterminate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'spread': 'NA', 'comment': 'SD was not estimated because of less number of participants in this events.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>CT of 2.5 mg/L) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.', 'unitOfMeasure': 'Percentage of time', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included participants from PK and micro-ITT analysis set. All participants reported under 'Overall Number of Participants Analyzed' included participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' =participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until end of late follow-up (Up to Day 45)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a study participant administered medicinal product,; the event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital abnormal/birth defect or considered an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received any amount of study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Hematology Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Hematocrit < 0.7*LLN and > 30% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit > 1.3* ULN and > 30% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin< 0.7* LLN and > 30% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin > 1.3* ULN and > 30% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes < 0.7* LLN and > 30% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes > 1.3* ULN and > 30% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes < 0.65* LLN and > 60% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes > 1.5* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils/Leukocytes < 0.65* LLN and > 75% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils/Leukocytes > 1.6* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes/Leukocytes > 4.0* ULN and > 300% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes/Leukocytes < 0.25* LLN and > 75% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes/Leukocytes > 1.5* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils/Leukocytes > 4.0* ULN and > 300% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Basophils/Leukocytes > 4.0* ULN and > 300% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelets < 0.65* LLN and > 50% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets > 1.5* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until TOC visit (Up to Day 28)', 'description': 'Criteria for potential clinically significant hematology results were as follows: hemoglobin, hematocrit and erythrocyte \\<0.7\\*lower limit of normal \\[LLN\\] and \\>30% decrease from Baseline (DFB); \\>1.3\\*upper limit of normal (ULN) and \\>30% increase from Baseline (IFB). Platelet count \\<0.65\\*LLN and \\> 50% decrease from baseline; \\> 1.5 \\* ULN and \\> 100% increase from baseline. leukocyte: \\< 0.65\\* LLN and \\> 60% decrease from baseline; \\> 1.5\\* ULN and 100% increase from baseline. Neutrophils/leukocytes \\< 0.65 \\* LLN and \\>75% decrease from baseline; \\> 1.6\\*ULN and \\> 100% increase from baseline. Lymphocytes/leukocytes \\< 0.25\\* LLN and \\> 75% decrease from baseline;\\> 1.5\\* ULN and \\> 100% increase from baseline, Eosinophils/leukocytes, Monocytes/leukocytes, Basophils/leukocytes \\> 4.0\\* ULN and \\> 300% increase from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received any amount of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants available for specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Potentially Clinically Significant Clinical Chemistry Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Aspartate Aminotransferase >3.0* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase > 3.0* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase < 0.5* LLN and > 80% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase > 3.0* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin > 1.5* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Direct Bilirubin > 2.0* ULN and > 150% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine > 2.0* ULN and > 100% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Sodium < 0.85* LLN and > 10% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sodium> 1.1* ULN and > 10% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium < 0.8* LLN and > 20% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium > 1.2* ULN and > 20% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Chloride< 0.8* LLN and > 20% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chloride > 1.2* ULN and > 20% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate < 0.7* LLN and > 40% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate > 1.3* ULN and > 40% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Calcium < 0.7* LLN and > 30% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Calcium > 1.3* ULN and > 30% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin < 0.5* LLN and > 50% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Albumin > 1.5* ULN and > 50% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose < 0.6* LLN and > 40% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose > 3.0* ULN and > 200% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen < 0.2* LLN and > 100% Decrease from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen > 3.0* ULN and > 200% Increase from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until At TOC visit (Up to Day 28)', 'description': 'Albumin \\< 0.5\\* LLN and\\> 50% decrease from baseline (DFB);\\> 1.5 \\* ULN and\\> 50% increase from baseline (IFB). Alkaline phosphatase \\< 0.5 \\* LLN and\\> 80% DFB;\\> 3.0 \\* ULN and\\> 100%. Alanine and Aspartate aminotransferase \\> 3.0 \\* ULN and\\> 100% IFB. Bicarbonate \\< 0.7 \\* LLN and \\> 40% DFB;\\> 1.3 \\* ULN and\\> 40% IFB. Blood urea nitrogen \\< 0.2 \\* LLN and \\> 100% DFB; \\> 3.0 \\* ULN and \\> 200% IFB. Calcium \\< 0.7 \\* LLN and \\> 30% DFB;\\> 1.3 \\* ULN and\\> 30% IFB. Chloride \\< 0.8 \\* LLN \\>and 20% DFB; \\> 1.2 \\* ULN and \\> 20% IFB. Creatinine \\> 2.0 \\* ULN and\\> 100% IFB; Glucose \\< 0.6 \\* LLN and\\> 40% DFB; \\> 3.0 \\* ULN and\\> 200% IFB. Potassium \\< 0.8 \\* LLN and \\> 20% DFB; \\> 1.2 \\* ULN and\\> 20% IFB. Sodium \\< 0.85 \\* LLN and\\> 10% DFB;\\> 1.1 \\* ULN and \\>10% IFB. Bilirubin \\> 1.5 \\* ULN and \\> 100% IFB.; Direct bilirubin \\> 2.0 \\* ULN and \\> 150% IFB.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received any amount of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants available for specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormalities in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Systolic BP (mmHg) Value more than (>) 150 and increase from baseline more than equal (≥ to 30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP (mmHg) Value less than (<) 90 and decrease from baseline more than equal (≥) 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP (mmHg) Value > 100 and increase from baseline ≥ 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP (mmHg) Value < 50 and decrease from baseline ≥ 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Heart Rate (BPM) Value < 40 or > 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '265', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment until TOC visit (Up to Day 28)', 'description': 'Vitals signs, included blood pressure and, heart rate. Blood pressure (BP) and heart rate were measured using a semiautomatic BP recording device with the participant in a supine position after at least 10 minutes of rest. Criteria for abnormalities included: Systolic BP (millimeters of mercury \\[mmHg\\]): value more than (\\>) 150 and increase from baseline more than equal (\\>= 30) or value less than (\\<) 90 and decrease from baseline \\>= 30; DBP: value \\> 100 and increase from baseline \\>=20 or Value \\< 50 and decrease from baseline \\>= 20; Heart Rate (beats per minute \\[BPM\\]): value \\< 40 or \\> 120.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who received any amount of study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Physical Examination Finding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Abdomen: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Abdomen: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Abdomen: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Ears: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ears: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ears:Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eyes: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Eyes End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eyes: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'General appearance: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'General appearance: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'General appearance: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Head: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Head: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Head: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lungs: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Lungs: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Lungs: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Lymph nodes: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph nodes: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph nodes: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Neurological: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Neurological: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Neurological: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Nose: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Nose: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nose: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Skin: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Skin: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Throat: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Throat: End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Throat: Test of Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, End of treatment (up to 24 hours post infusion on Day 14) and Test of Cure (Day 28)', 'description': 'A complete physical examination was performed and included an assessment of the following: general appearance including site of infection, skin, head and throat (head, eyes, ears, nose, and throat), lymph nodes, lungs, cardiovascular (CV), abdomen, musculoskeletal, and neurological systems.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety analysis set included all participants who received any amount of study treatment. Here, 'Number Analyzed' signifies number of participants available for specified rows."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (latest non-missing value before start of treatment) and Day 3', 'description': 'Standard 12-lead ECGs were recorded with the participants in the supine position after the participant had rested in this position for 10 minutes. Clinically significant findings were based on investigators assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who received any amount of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '80.6'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '65.8', 'upperLimit': '80.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '11.5', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all randomized participants regardless of the treatment received.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure at EOT Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '85.1'}, {'value': '80.9', 'groupId': 'OG001', 'lowerLimit': '72.0', 'upperLimit': '87.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '9.4', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure at EOT Visit: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '86.8'}, {'value': '81.9', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '88.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '9.9', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on CE analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure at EOT Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '89.7'}, {'value': '83.5', 'groupId': 'OG001', 'lowerLimit': '74.2', 'upperLimit': '90.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '12.0', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who have at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure by Type of Infection at EOT Visit: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'cIAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '86.5'}, {'value': '79.8', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '86.6'}]}]}, {'title': 'HAP/VAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '48.1', 'upperLimit': '70.1'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '39.4', 'upperLimit': '70.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '11.9', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'cIAI', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-15.2', 'ciUpperLimit': '23.4', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'HAP/VAP', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants regardless of the treatment received. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure by Type of Infection at EOT Visit: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'cIAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '92.8'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '91.8'}]}]}, {'title': 'HAP/VAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000', 'lowerLimit': '43.2', 'upperLimit': '71.4'}, {'value': '68.2', 'groupId': 'OG001', 'lowerLimit': '47.4', 'upperLimit': '84.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '13.2', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'cIAI', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical cure rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '14.9', 'estimateComment': 'CI for the difference was calculated using the unstratified Miettinen and Nurminen method.', 'groupDescription': 'HAP/VAP', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 24)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "CE analysis set. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible, EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.5', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible, CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}, {'value': '74.2', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenemase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on European Committee on Antimicrobial Susceptibility Testing \\[EUCAST\\] criteria and Clinical and Laboratory Standards Institute \\[CLSI\\] criteria, Extended spectrum beta-lactamases \\[ESBL\\]-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible, EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible, CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000'}, {'value': '61.3', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenemase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set was a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at EOT Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible, EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000'}, {'value': '78.6', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible, CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.7', 'groupId': 'OG000'}, {'value': '76.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}, {'value': '82.4', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenemase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at TOC Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible, EUCAST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000'}, {'value': '60.7', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible, CLSI Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, EUCAST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible, CLSI Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenemase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per Participant Microbiological Response at EOT Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}, {'value': '83.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. Participants with a per participant response of indeterminate were excluded from this analysis. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per Participant Microbiological Response at EOT Visit : ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000'}, {'value': '86.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at EOT Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus anginosus group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides fragilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides thetaiotaomicron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at at TOC Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus anginosus group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides fragilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides thetaiotaomicron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at EOT Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus anginosus group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides fragilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides thetaiotaomicron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at TOC Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Streptococcus anginosus group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides fragilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Bacteroides thetaiotaomicron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '78.6', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible : EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000'}, {'value': '80.6', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible : CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible : EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set=subset of ITT analysis set \\& included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to start of study treatment.Here, 'Overall Number of Participants Analyzed' signifies participants included in micro-ITT analysis set and contributed data to table. Number Analyzed=number of participants evaluable for specified rows and participants with per participant response of indeterminate were excluded from analysis."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible : EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000'}, {'value': '73.7', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set=subset of ITT analysis set \\& included all participants who had at least 1 Gram-negative baseline pathogen from an adequate specimen obtained prior to start of study treatment. Here, 'Overall Number of Participants Analyzed' signifies participants included in micro-ITT analysis set and contributed data to table. Number Analyzed=number of participants evaluable for specified rows and participants with per participant response of indeterminate were excluded from analysis."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at EOT Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ME analysis set =all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at TOC Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '60.7', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Serene Carbapenamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ME analysis set =all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.3', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible : EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.1', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Serine-carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000'}, {'value': '58.1', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000'}, {'value': '56.8', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '36.4', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Serine-carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Micro-ITT analysis set is a subset of the ITT analysis set and included all participants who had at least one Gram-negative baseline pathogen from an adequate specimen obtained prior to the start of study treatment. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at EOT Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}, {'value': '82.8', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Serine-carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at TOC Visit: ME Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'ATM non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}, {'title': 'ATM non-susceptible: EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible: CLSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Meropenem non-susceptible : EUCAST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'ESBL-positive:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000'}, {'value': '76.5', 'groupId': 'OG001'}]}]}, {'title': 'Carbapenemase-positive:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Serine-carbapenemase-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Metallo-beta-lactamase-positive:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ME analysis set included all participants commonly included in both micro-ITT and CE analysis sets and included participants who had at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants According to Total Score for the Composite Endpoint of Symptom-Based Objective Clinical Measures: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'timeFrame': 'Up to Day 28', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all randomized participants regardless of receipt of study drug. A composite scoring system was never developed and therefore there is no data to report for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants According to Total Score for the Composite Endpoint of Symptom-Based Objective Clinical Measures: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'timeFrame': 'Up to Day 28', 'description': 'CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.', 'reportingStatus': 'POSTED', 'populationDescription': 'CE analysis set. A composite scoring system was never developed and therefore there is no data to report for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Died on or Before 14 Days From Randomization: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to 14 days', 'description': 'Percentage of participants who died on or before 14 days from randomization is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all randomized participants regardless of receipt of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Length of Hospital Stay up to TOC Visit: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '8.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization up to Day 28', 'description': 'The total length of hospital stay was defined as the total number of calendar days on which the participant was in the hospital from the date of randomization up to and including the specified time point of TOC.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total Length of Hospital Stay up to TOC Visit: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'spread': '8.55', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '7.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization up to Day 28', 'description': 'The total length of hospital stay was defined as the total number of calendar days on which the participant was in the hospital from the date of randomization up to and including the specified time point of TOC. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CE analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '3.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study treatment until last dose of treatment (Up to 14 days)', 'description': 'The duration of therapy in calendar days were calculated as follows: Date of last dose of study drug - date of first dose of study drug +1.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who received any amount of study treatment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Intensive Care Unit (ICU) Stay: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '9.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'The total length of ICU stay was defined as the total number of calendar days on which the participant was in ICU for the period from date of randomization until the TOC visit.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Intensive Care Unit (ICU) Stay: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '9.23', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '9.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'The total length of ICU stay was defined as the total number of calendar days on which the participant was in ICU for the period from date of randomization until the TOC visit. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "CE analysis set. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Admitted to the ICU: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Number of participants admitted to the ICU up to TOC were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis set included all randomized participants regardless of receipt of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Admitted to the ICU: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'The number of participants admitted to the ICU were reported in this outcome measure. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE analysis set.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Mechanical Ventilation: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Number of participants with mechanical ventilation were reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Mechanical Ventilation: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Number of participants with mechanical ventilation were reported in this outcome measure. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "CE analysis set. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Mechanical Ventilation in HAP/VAP Participants: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '11.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Duration of mechanical ventilation was defined as the total number of calendar days on which the participant required mechanical ventilation from the date of randomization up to TOC.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants regardless of receipt of study drug. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Mechanical Ventilation in HAP/VAP Participants: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '8.99', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '11.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Duration of mechanical ventilation was defined as the total number of calendar days on which the participant required mechanical ventilation from the date of randomization up to TOC. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "CE analysis set. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Unplanned Surgical Interventions in Complicated Intra-abdominal Infections (cIAI) Participants: ITT Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Unplanned surgical interventions was defined as those occurring after the initial qualifying surgical intervention and prior to the TOC visit. Number of cIAI participants with unplanned surgical intervention according to clinical response categories of cure and failure is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT analysis set included all randomized participants regardless of receipt of study drug. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Unplanned Surgical Interventions in cIAI Participants: CE Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'OG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'classes': [{'title': 'Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Unplanned surgical interventions was defined as those occurring after the initial qualifying surgical intervention and prior to the TOC visit. Number of cIAI participants with unplanned surgical intervention according to clinical response categories of cure and failure is reported in this outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "CE analysis set. All participants reported under 'Overall Number of Participants Analyzed' include participants evaluable for this outcome measure and contributed data to the table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for specified rows."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'FG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '282'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'Participants With cIAI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'Participants With HAP/VAP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants who were hospitalized with a diagnosis of complicated intra-abdominal infection (cIAI) or nosocomial pneumonia (NP) including hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) were enrolled. This study was conducted across 20 countries from 05-Apr-2018 to 23-Feb-2023.', 'preAssignmentDetails': 'A total of 461 participants were screened of which 38 failed screening and 1 participant was not randomized due to lack of study drug at the site. A total of 422 participants were randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aztreonam-avibactam ± Metronidazole', 'description': 'Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive a loading dose of aztreonam-avibactam (ATM-AVI) by intravenous (IV) infusion over 30 minutes, immediately followed by an extended loading dose of ATM-AVI by IV infusion over 3 hours on Day 1. Participants were administered a maintenance dose of ATM-AVI by IV infusion over 3 hours on Days 2 to 14. Participants with cIAI also received metronidazole (MTZ) 500 milligrams (mg) IV every 8 hours.'}, {'id': 'BG001', 'title': 'Meropenem± Colistimethate', 'description': "Participants hospitalized with cIAI or NP (including HAP and VAP) were randomized to receive 1000 mg meropenem every 8 hours by IV infusion. A higher dose of 2000 mg was given by IV infusion over 180 minutes if carbapenem resistant pathogen was strongly suspected. Participants were administered colistimethate sodium at investigator's discretion."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '17.84', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '16.30', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '17.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Mixed', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent to Treat (ITT) analysis set included all randomized participants regardless of receipt of study drug. Participants were analyzed according to the treatment to which they were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-18', 'size': 1517153, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-21T09:39', 'hasProtocol': True}, {'date': '2020-06-25', 'size': 524058, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-21T09:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "An independent adjudication committee (central blinded assessor) will be convened at regular intervals during the study. The adjudication committee will be blinded to study treatment and will review the clinical response assessments at each visit. In case of a discrepancy with the Investigator's assignment of clinical response, the adjudication committee's assessment will prevail.\n\nIn addition, for cIAI subjects classified as a clinical failure, and all cIAI subjects classified as a cure who undergo another procedure (eg, another surgical procedure) subsequent to randomization, the expert panel will review the adequacy of the surgical source control."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2017-10-06', 'resultsFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2017-10-27', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-16', 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit: ITT Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure at EOT Visit: Micro-ITT Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure at EOT Visit: CE Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens."}, {'measure': 'Percentage of Participants With Clinical Cure at EOT Visit: ME Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure by Type of Infection at EOT Visit: ITT Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure by Type of Infection at EOT Visit: CE Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 24)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens."}, {'measure': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on European Committee on Antimicrobial Susceptibility Testing \\[EUCAST\\] criteria and Clinical and Laboratory Standards Institute \\[CLSI\\] criteria, Extended spectrum beta-lactamases \\[ESBL\\]-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set', 'timeFrame': 'At TOC (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at EOT Visit: ME Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Clinical Cure by Pathogen Resistance Type at TOC Visit: ME Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. Percentage of participants with clinical cure by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per Participant Microbiological Response at EOT Visit: Micro-ITT Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.'}, {'measure': 'Percentage of Participants With Favorable Per Participant Microbiological Response at EOT Visit : ME Analysis Set', 'timeFrame': 'At EOT visit (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.'}, {'measure': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at EOT Visit: Micro-ITT Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.'}, {'measure': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at at TOC Visit: Micro-ITT Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.'}, {'measure': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at EOT Visit: ME Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.'}, {'measure': 'Number of Participants With Favorable Microbiological Response Per-Pathogen at TOC Visit: ME Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Only those pathogens are reported which had more than or equal to 10 isolates for either treatment group.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible and Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at EOT Visit: ME Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response by Pathogen Resistance Type at TOC Visit: ME Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at EOT Visit: Micro-ITT Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at TOC Visit: Micro-ITT Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at EOT Visit: ME Analysis Set', 'timeFrame': 'At EOT (Within 24 hours after last infusion on Day 14)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Favorable Per-Pathogen Microbiological Response by Pathogen Resistance Type at TOC Visit: ME Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Percentage of participants with favorable per-pathogen microbiological response by pathogen resistance type (ATM non-susceptible, Meropenem non-susceptible based on EUCAST criteria and CLSI criteria, ESBL-positive, Carbapenemase-positive, Serene Carbapenemase and Metallo-beta-lactamase-positive) is reported in this outcome measure.'}, {'measure': 'Number of Participants According to Total Score for the Composite Endpoint of Symptom-Based Objective Clinical Measures: ITT Analysis Set', 'timeFrame': 'Up to Day 28'}, {'measure': 'Number of Participants According to Total Score for the Composite Endpoint of Symptom-Based Objective Clinical Measures: CE Analysis Set', 'timeFrame': 'Up to Day 28', 'description': 'CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.'}, {'measure': 'Percentage of Participants Who Died on or Before 14 Days From Randomization: ITT Analysis Set', 'timeFrame': 'From randomization up to 14 days', 'description': 'Percentage of participants who died on or before 14 days from randomization is reported in this outcome measure.'}, {'measure': 'Total Length of Hospital Stay up to TOC Visit: ITT Analysis Set', 'timeFrame': 'From randomization up to Day 28', 'description': 'The total length of hospital stay was defined as the total number of calendar days on which the participant was in the hospital from the date of randomization up to and including the specified time point of TOC.'}, {'measure': 'Total Length of Hospital Stay up to TOC Visit: CE Analysis Set', 'timeFrame': 'From randomization up to Day 28', 'description': 'The total length of hospital stay was defined as the total number of calendar days on which the participant was in the hospital from the date of randomization up to and including the specified time point of TOC. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.'}, {'measure': 'Duration of Study Treatment', 'timeFrame': 'From first dose of study treatment until last dose of treatment (Up to 14 days)', 'description': 'The duration of therapy in calendar days were calculated as follows: Date of last dose of study drug - date of first dose of study drug +1.'}, {'measure': 'Length of Intensive Care Unit (ICU) Stay: ITT Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'The total length of ICU stay was defined as the total number of calendar days on which the participant was in ICU for the period from date of randomization until the TOC visit.'}, {'measure': 'Length of Intensive Care Unit (ICU) Stay: CE Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'The total length of ICU stay was defined as the total number of calendar days on which the participant was in ICU for the period from date of randomization until the TOC visit. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.'}, {'measure': 'Number of Participants Admitted to the ICU: ITT Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Number of participants admitted to the ICU up to TOC were reported in this outcome measure.'}, {'measure': 'Number of Participants Admitted to the ICU: CE Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'The number of participants admitted to the ICU were reported in this outcome measure. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.'}, {'measure': 'Number of Participants With Mechanical Ventilation: ITT Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Number of participants with mechanical ventilation were reported in this outcome measure.'}, {'measure': 'Number of Participants With Mechanical Ventilation: CE Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Number of participants with mechanical ventilation were reported in this outcome measure. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.'}, {'measure': 'Duration of Mechanical Ventilation in HAP/VAP Participants: ITT Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Duration of mechanical ventilation was defined as the total number of calendar days on which the participant required mechanical ventilation from the date of randomization up to TOC.'}, {'measure': 'Duration of Mechanical Ventilation in HAP/VAP Participants: CE Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Duration of mechanical ventilation was defined as the total number of calendar days on which the participant required mechanical ventilation from the date of randomization up to TOC. CE analysis set: all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.'}, {'measure': 'Number of Participants With Unplanned Surgical Interventions in Complicated Intra-abdominal Infections (cIAI) Participants: ITT Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Unplanned surgical interventions was defined as those occurring after the initial qualifying surgical intervention and prior to the TOC visit. Number of cIAI participants with unplanned surgical intervention according to clinical response categories of cure and failure is reported in this outcome measure.'}, {'measure': 'Number of Participants With Unplanned Surgical Interventions in cIAI Participants: CE Analysis Set', 'timeFrame': 'From randomization until TOC visit (Up to Day 28)', 'description': 'Unplanned surgical interventions was defined as those occurring after the initial qualifying surgical intervention and prior to the TOC visit. Number of cIAI participants with unplanned surgical intervention according to clinical response categories of cure and failure is reported in this outcome measure.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Intent-To-Treat (ITT) Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% confidence interval (CI) was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure at TOC Visit: Clinically Evaluable (CE) Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at TOC Visit: Microbiological Intent-To-Treat (Micro-ITT) Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure at TOC Visit: Microbiologically Evaluable (ME) Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: ITT Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method."}, {'measure': 'Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: CE Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': "Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \\<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens."}, {'measure': 'Percentage of Participants With Clinical Cure in Participants With Metallo-beta-lactamase (MBL) Positive Pathogen at TOC Visit: Micro-ITT Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee.'}, {'measure': 'Percentage of Participants With Clinical Cure in Participants With MBL Positive Pathogen at TOC Visit: ME Analysis Set', 'timeFrame': 'At TOC visit (Day 28)', 'description': 'Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit: Micro- ITT Analysis Set', 'timeFrame': 'At TOC visit day (28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.'}, {'measure': 'Percentage of Participants With Favorable Per-Participant Microbiological Response at TOC Visit: ME Analysis Set', 'timeFrame': 'At TOC Visit (Day 28)', 'description': 'Participants were determined to have a favorable microbiological response if all baseline pathogens for that participant had a favorable outcome (eradicated or presumed eradicated). Eradication: Absence of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure.'}, {'measure': 'Percentage of Participants Who Died on or Before 28 Days After Randomization: ITT Analysis Set', 'timeFrame': 'From randomization up to 28 days', 'description': 'Percentage of participants who died on or before 28 days after randomization is reported in this outcome measure.'}, {'measure': 'Percentage of Participants Who Died on or Before 28 Days After Randomization: Micro-ITT Analysis Set', 'timeFrame': 'From randomization up to 28 days', 'description': 'Percentage of participants who died on or before 28 days after randomization is reported in this outcome measure.'}, {'measure': 'Plasma Concentration of Aztreonam', 'timeFrame': 'Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4', 'description': 'Plasma concentration for aztreonam according to renal function (augmented, normal and mild, moderate and severe is presented in this outcome measure. Augmented = Creatinine clearance (CrCL) \\> 150 milliliters per minute (mL/min); Normal \\& Mild = CrCL \\> 50 to \\<=150 mL/min; Moderate = CrCL \\> 30 to ≤ 50 mL/min; Severe = CrCL \\> 15 to ≤ 30 mL/min.'}, {'measure': 'Plasma Concentration of Avibactam', 'timeFrame': 'Anytime between 25 to 30 minutes, 3.25 to 3.5 hours, 5.5 to 6.5 hours, 7.5 to 8.5 hours post start of infusion on Day 1; 2.75 to 3 hours, 3.5 to 4.5 hours, 5 to 6 and 7 to 8 hours post start of infusion on Day 4', 'description': 'Plasma concentration for avibactam according to renal function (augmented, normal and mild, moderate and severe is presented in this outcome measure. Augmented = CrCL \\> 150 mL/min; Normal \\& Mild = CrCL \\> 50 to \\<=150 mL/min; Moderate = CrCL \\> 30 to ≤ 50 mL/min; Severe = CrCL \\> 15 to ≤ 30 mL/min.'}, {'measure': 'Maximum Plasma Concentration for a Dosing Interval at Steady-State (Cmax, ss) According to Clinical Response by Infection Type at TOC: Aztreonam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted maximum plasma concentration for a dosing interval at steady-state (Cmax,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Percentage of Time That Free Plasma Concentrations Are Above the Minimum Inhibitory Concentration Over a Dosing Interval (%fT>MIC Aztreonam (ATM) of 8 mg/L) According to Clinical Response by Infection Type at TOC: Aztreonam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>MIC ATM of 8 mg/L) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss ) According to Clinical Response by Infection Type at TOC: Aztreonam', 'timeFrame': '0 to 24 hours at TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss) According to Microbiological Response by Infection Type at TOC: Aztreonam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (Cmax,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Microbiological Response by Infection Type at TOC: Aztreonam', 'timeFrame': '0 to 24 hours at TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Percentage of Time That Free Plasma Concentrations Are Above the Minimum Inhibitory Concentration Over a Dosing Interval (%fT>MIC Aztreonam (ATM) of 8 mg/L) According to Microbiological Response by Infection Type at TOC: Aztreonam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>MIC ATM of 8 mg/L) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Clinical Response by Infection Type at TOC: Avibactam', 'timeFrame': '0 to 24 hours at TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss ) According to Clinical Response by Infection Type at TOC: Avibactam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (Cmax,ss) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Percent of Time That Free Plasma Concentrations Are Above the Threshold Concentration Over a Dosing Interval (%fT>CT of 2.5mg/L) According to Clinical Response by Infection Type at TOC: Avibactam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>CT of 2.5mg/L) for participants who received aztreonam-avibactam in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Clinical response categories included, clinical cure=improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. For cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Failure was defined as participants who met any of the following criteria like death (after receiving at least 48 hours of study treatment) and participants who received treatment with further antibiotics for the index infection. Indeterminate was defined as death (after receiving less than 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Area Under the Plasma Concentration-time Curve Over 24 Hours at Steady-state (AUC24,ss) According to Microbiological Response by Infection Type at TOC: Avibactam', 'timeFrame': '0 to 24 hours At TOC (Day 28)', 'description': 'Population PK predicted (AUC24,ss) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving\\<48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Maximum Plasma Concentration for a Dosing Interval at Steady-state (Cmax,ss (mg/L)) According to Microbiological Response by Infection Type at TOC: Avibactam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (Cmax,ss (mg/L)) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving\\<48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Percent of Time That Free Plasma Concentrations Are Above the Threshold Concentration Over a Dosing Interval; (%fT>CT of 2.5 mg/L) According to Microbiological Response by Infection Type at TOC: Avibactam', 'timeFrame': 'At TOC (Day 28)', 'description': 'Population PK predicted (%fT\\>CT of 2.5 mg/L) for participants who received ATM-AVI in studies C3601002 (NCT03329092) and C3601009 (NCT03580044). Microbiological response included Favorable =baseline pathogens for participant had a favorable outcome. Eradication: Absence of causative pathogen from an appropriately obtained specimen at site of infection. Presumed eradication: repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure. Unfavorable=persistence, persistence with increasing MIC, or presumed persistence. Persistence= Causative organism still present from appropriately obtained specimen at site of infection. Presumed persistence= Participant assessed as a clinical failure and repeat culture of specimens were not performed/clinically indicated. Indeterminate = death (after receiving \\< 48 hours of study treatment) and for cIAI participants inadequate infection source control at time of initial surgical procedure.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious AEs', 'timeFrame': 'From start of study treatment until end of late follow-up (Up to Day 45)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a study participant administered medicinal product,; the event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital abnormal/birth defect or considered an important medical event.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Hematology Abnormalities', 'timeFrame': 'From start of study treatment until TOC visit (Up to Day 28)', 'description': 'Criteria for potential clinically significant hematology results were as follows: hemoglobin, hematocrit and erythrocyte \\<0.7\\*lower limit of normal \\[LLN\\] and \\>30% decrease from Baseline (DFB); \\>1.3\\*upper limit of normal (ULN) and \\>30% increase from Baseline (IFB). Platelet count \\<0.65\\*LLN and \\> 50% decrease from baseline; \\> 1.5 \\* ULN and \\> 100% increase from baseline. leukocyte: \\< 0.65\\* LLN and \\> 60% decrease from baseline; \\> 1.5\\* ULN and 100% increase from baseline. Neutrophils/leukocytes \\< 0.65 \\* LLN and \\>75% decrease from baseline; \\> 1.6\\*ULN and \\> 100% increase from baseline. Lymphocytes/leukocytes \\< 0.25\\* LLN and \\> 75% decrease from baseline;\\> 1.5\\* ULN and \\> 100% increase from baseline, Eosinophils/leukocytes, Monocytes/leukocytes, Basophils/leukocytes \\> 4.0\\* ULN and \\> 300% increase from baseline.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Clinical Chemistry Abnormalities', 'timeFrame': 'From start of study treatment until At TOC visit (Up to Day 28)', 'description': 'Albumin \\< 0.5\\* LLN and\\> 50% decrease from baseline (DFB);\\> 1.5 \\* ULN and\\> 50% increase from baseline (IFB). Alkaline phosphatase \\< 0.5 \\* LLN and\\> 80% DFB;\\> 3.0 \\* ULN and\\> 100%. Alanine and Aspartate aminotransferase \\> 3.0 \\* ULN and\\> 100% IFB. Bicarbonate \\< 0.7 \\* LLN and \\> 40% DFB;\\> 1.3 \\* ULN and\\> 40% IFB. Blood urea nitrogen \\< 0.2 \\* LLN and \\> 100% DFB; \\> 3.0 \\* ULN and \\> 200% IFB. Calcium \\< 0.7 \\* LLN and \\> 30% DFB;\\> 1.3 \\* ULN and\\> 30% IFB. Chloride \\< 0.8 \\* LLN \\>and 20% DFB; \\> 1.2 \\* ULN and \\> 20% IFB. Creatinine \\> 2.0 \\* ULN and\\> 100% IFB; Glucose \\< 0.6 \\* LLN and\\> 40% DFB; \\> 3.0 \\* ULN and\\> 200% IFB. Potassium \\< 0.8 \\* LLN and \\> 20% DFB; \\> 1.2 \\* ULN and\\> 20% IFB. Sodium \\< 0.85 \\* LLN and\\> 10% DFB;\\> 1.1 \\* ULN and \\>10% IFB. Bilirubin \\> 1.5 \\* ULN and \\> 100% IFB.; Direct bilirubin \\> 2.0 \\* ULN and \\> 150% IFB.'}, {'measure': 'Number of Participants With Abnormalities in Vital Signs', 'timeFrame': 'From start of study treatment until TOC visit (Up to Day 28)', 'description': 'Vitals signs, included blood pressure and, heart rate. Blood pressure (BP) and heart rate were measured using a semiautomatic BP recording device with the participant in a supine position after at least 10 minutes of rest. Criteria for abnormalities included: Systolic BP (millimeters of mercury \\[mmHg\\]): value more than (\\>) 150 and increase from baseline more than equal (\\>= 30) or value less than (\\<) 90 and decrease from baseline \\>= 30; DBP: value \\> 100 and increase from baseline \\>=20 or Value \\< 50 and decrease from baseline \\>= 20; Heart Rate (beats per minute \\[BPM\\]): value \\< 40 or \\> 120.'}, {'measure': 'Number of Participants With Abnormal Physical Examination Finding', 'timeFrame': 'Screening, End of treatment (up to 24 hours post infusion on Day 14) and Test of Cure (Day 28)', 'description': 'A complete physical examination was performed and included an assessment of the following: general appearance including site of infection, skin, head and throat (head, eyes, ears, nose, and throat), lymph nodes, lungs, cardiovascular (CV), abdomen, musculoskeletal, and neurological systems.'}, {'measure': 'Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline (latest non-missing value before start of treatment) and Day 3', 'description': 'Standard 12-lead ECGs were recorded with the participants in the supine position after the participant had rested in this position for 10 minutes. Clinically significant findings were based on investigators assessment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complicated intra-abdominal infection', 'Hosptial acquired pneumonia', 'Ventilator associated pneumonia', 'Gram negative infections', 'Metallo-beta lactamase', 'Multi drug resistant pathogens'], 'conditions': ['Complicated Intra-abdominal Infection', 'Hosptial Acquired Pneumonia', 'Ventilator Associated Pneumonia']}, 'referencesModule': {'references': [{'pmid': '41269522', 'type': 'DERIVED', 'citation': 'Raber SR, Xie R, Rogers H, Soto E, Arhin FF, Stone GG, Leister-Tebbe H, Chow JW. Microbiological, Clinical, and Pharmacokinetic/Pharmacodynamic Data to Support EUCAST Aztreonam-Avibactam Minimum Inhibitory Concentration Susceptibility Breakpoints Against Enterobacterales. Infect Dis Ther. 2025 Nov 21. doi: 10.1007/s40121-025-01267-3. Online ahead of print.'}, {'pmid': '40530972', 'type': 'DERIVED', 'citation': 'Xie R, Rogers H, Chow JW, Soto E, Raber SR. Population pharmacokinetic/pharmacodynamic modeling to optimize aztreonam-avibactam dose regimens for adult patients. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0195024. doi: 10.1128/aac.01950-24. Epub 2025 Jun 18.'}, {'pmid': '39389071', 'type': 'DERIVED', 'citation': 'Carmeli Y, Cisneros JM, Paul M, Daikos GL, Wang M, Torre-Cisneros J, Singer G, Titov I, Gumenchuk I, Zhao Y, Jimenez-Rodriguez RM, Liang L, Chen G, Pyptiuk O, Aksoy F, Rogers H, Wible M, Arhin FF, Luckey A, Leaney JL, Pypstra R, Chow JW; COMBACTE-CARE consortium REVISIT study group. Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. Lancet Infect Dis. 2025 Feb;25(2):218-230. doi: 10.1016/S1473-3099(24)00499-7. Epub 2024 Oct 7.'}, {'pmid': '38252170', 'type': 'DERIVED', 'citation': 'Das S, Riccobene T, Carrothers TJ, Wright JG, MacPherson M, Cristinacce A, McFadyen L, Xie R, Luckey A, Raber S. Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluation. Eur J Clin Pharmacol. 2024 Apr;80(4):529-543. doi: 10.1007/s00228-023-03609-x. Epub 2024 Jan 22.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3601002', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.', 'detailedDescription': 'A Phase 3 Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study To Determine The Efficacy, Safety And Tolerability Of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem±Colistin (MER±COL) For The Treatment Of Serious Infections Due To Gram Negative Bacteria, Including Metallo Β Lactamase (MBL) - Producing Multidrug Resistant Pathogens, For Which There Are Limited Or No Treatment Options'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll subjects:\n\n1. Male or female from 18 years of age\n2. Provision of informed consent\n3. Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment\n4. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy test\n\nAdditional for cIAI:\n\n1. Diagnosis of cIAI, EITHER:\n\n Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry\n2. Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug\n\nAdditional for HAP/VAP:\n\n1. Onset symptoms \\> 48h after admission to or \\<7 days after discharge from an inpatient care facility\n2. New or worsening infiltrate on CXR or CT scan\n3. Clinical signs and symptoms and laboratory findings consistent with HAP/VAP\n4. Respiratory specimen obtained for Gram stain and culture following onset of symptoms and prior to randomisation\n\nExclusion criteria:\n\nAll subjects:\n\n1. APACHE II score \\> 30\n2. Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species\n3. Receipt of \\>24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)\n4. History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs\n5. Known Clostridium difficle associated diarrhoea\n6. Requirement for effective concomitant systemic antibacterials or antifungals\n7. Creatinine clearance ≤15 ml/min or requirement or expectation for renal replacement therapy\n8. Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure\n9. Hepatic disease as indicated by AST or ALT \\>3 × ULN. Patients with AST and/or ALT up to 5 × ULN are eligible if acute and documented by the investigator as being directly related infectious process\n10. Patient has a total bilirubin \\>2 × ULN, unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilbert's disease\n11. ALP \\>3 × ULN. Patients with values \\>3 × ULN and \\<5 x ULN are eligible if acute and directly related to the infectious process being treated\n12. Absolute neutrophil count \\<500/mm3\n13. Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.\n14. Any other condition that may confound the results of the study or pose additional risks to the subject\n15. Unlikely to comply with protocol\n16. History of epilepsy or seizure disorders excluding febrile seizures of childhood\n\nAdditional for cIAI\n\n1. Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery \\< 24 hours of diagnosis primary etiology is not likely to be infectious\n2. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess\n3. Prior liver, pancreas or small-bowel transplant\n4. Staged abdominal repair (STAR), open abdomen technique or marsupialisation\n\nAdditional for HAP/VAP\n\n1. APACHE II score \\< 10\n2. Known or high likelihood of Gram-positive monomicrobial infection\n3. Lung abscess, pleural empyema, post-obstructive pneumonia\n4. Lung or heart transplant\n5. Myasthenia gravis"}, 'identificationModule': {'nctId': 'NCT03329092', 'acronym': 'REVISIT', 'briefTitle': 'A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS', 'orgStudyIdInfo': {'id': 'C3601002'}, 'secondaryIdInfos': [{'id': 'D4910C00004', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2017-002742-68', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aztreonam-Avibactam ± Metronidazole', 'description': 'All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover', 'interventionNames': ['Drug: ATM-AVI', 'Drug: MTZ']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meropenem ± Colistin', 'description': "All patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice", 'interventionNames': ['Drug: MER', 'Drug: COL']}], 'interventions': [{'name': 'ATM-AVI', 'type': 'DRUG', 'description': '(Creatinine clearance \\> 50 mL/min) 6500 mg ATM/2167 mg (loading dose, extended loading dose and maintenance dose) by iv infusion on Day 1 followed by a total daily dose of 6000 mg ATM/2000 mg AVI\n\n(Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1417 mg AVI on Day 1 (loading dose, extended loading dose, maintenance dose) followed by total daily dose 3000 mg ATM/1000 mg AVI\n\n(Creatinine clearance 16 - 30 mL/min) 2700 mg ATM/900 mg AVI on Day 1 (loading dose, extended loading dose maintenance dose), followed by total daily dose 2025 mg ATM/675 mg AVI', 'armGroupLabels': ['Aztreonam-Avibactam ± Metronidazole']}, {'name': 'MTZ', 'type': 'DRUG', 'description': 'For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h', 'armGroupLabels': ['Aztreonam-Avibactam ± Metronidazole']}, {'name': 'MER', 'type': 'DRUG', 'description': 'Where pathogen initially not suspected of being MER-resistant:\n\n(Creatinine clearance \\> 50 mL/min) 1000 mg meropenem by 30 min iv infusion q8h\n\n(Creatinine clearance 26 - 50 mL/min) 1000mg meropenem by 30 min iv infusion q12h\n\n(Creatinine clearance 16 - 25 mL/min) 500 mg meropenem by 30 min iv infusion q12h\n\nWhere pathogen initially suspected of being MER-resistant (Creatinine clearance \\> 50 mL/min) 2000 mg meropenem by 180 min iv infusion q8h\n\n(Creatinine clearance 26 - 50 mL/min) 2000 mg meropenem by 180 min iv infusion q12h\n\n(Creatinine clearance 16 - 25 mL/min) 1000 mg meropenem by 180 min iv infusion q12h', 'armGroupLabels': ['Meropenem ± Colistin']}, {'name': 'COL', 'type': 'DRUG', 'description': 'Loading dose 9 million IU by 30 -60 min iv infusion (6 million IU where weight \\< 60 kg) followed by one of the following maintenance doses:\n\n(Creatinine clearance \\> 50 mL/min) after a 12h interval, commence maintenance dosing 9 million IU daily in 2 or 3 divided doses by 30 -60 min iv infusions.\n\n(Creatinine clearance 31 - 50 mL/min) After a 24 hr interval, commence maintenance dosing of 6 million IU daily in 2 divided doses by 30 -60 min iv infusion\n\n(Creatinine clearance 21 - 30 mL/min) After a 24 hr interval, commence maintenance dosing 5 million IU daily in 2 divided doses by 30 -60 min iv infusion\n\n(Creatinine clearance 16 - 20 mL/min) after a 24 hr interval, commence maintenance dosing 4 million IU daily in 2 divided doses by 30 -60 min iv infusion', 'armGroupLabels': ['Meropenem ± Colistin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '62781', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Sanatorio Britanico', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'S3016', 'city': 'Santo Tomé', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Sanatorio Servicios Medicos SM', 'geoPoint': {'lat': -31.66274, 'lon': -60.7653}}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital San Roque', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Hospital Queen Joanna ISUL, Clinic of Surgery', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '6003', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'facility': "University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD", 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '363000', 'city': 'Zhangzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhangzhou Municipal Hospital of Fujian Province', 'geoPoint': {'lat': 24.51333, 'lon': 117.65556}}, {'zip': '510280', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'ZhuJiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '518035', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "The Second People's Hospital of Shenzhen", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '541001', 'city': 'Guilin', 'state': 'Guangxi', 'country': 'China', 'facility': 'Affiliated Hospital of Guilin Medical University', 'geoPoint': {'lat': 25.28022, 'lon': 110.29639}}, {'zip': '530022', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': "Nanning First People's Hospital", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Changsha Third Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410005', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': "Hunan Province People's Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '014000', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 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