Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT01808092
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2013-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'Croatia', 'Greece', 'Lithuania', 'Thailand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'David.wilson2@astrazeneca.com', 'phone': '+44 1625 517830', 'title': 'David Wilson, Statistical Team Leader - Infection', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.', 'description': "AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.", 'eventGroups': [{'id': 'EG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem', 'otherNumAtRisk': 405, 'otherNumAffected': 198, 'seriousNumAtRisk': 405, 'seriousNumAffected': 75}, {'id': 'EG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo', 'otherNumAtRisk': 403, 'otherNumAffected': 195, 'seriousNumAtRisk': 403, 'seriousNumAffected': 54}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 38, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 65, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 68, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 20, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 47, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 40, 'numAffected': 33}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diabetes insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intentional medical device removal by patient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Subacute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'CNS ventriculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Enterobacter pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'HIV infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tracheostomy malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weaning failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchioloalveolar carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Brachial plexopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchial secretion retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'OG000'}, {'value': '370', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Clinical cure', 'categories': [{'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'percentage: units for RD are %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-10.76', 'ciUpperLimit': '2.46', 'pValueComment': 'P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \\<= -12.5%.', 'groupDescription': 'Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set', 'statisticalMethod': '% Risk Difference (RD)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.', 'nonInferiorityComment': 'The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.'}, {'type': 'PRIMARY', 'title': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Clinical cure', 'categories': [{'measurements': [{'value': '199', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'percentage: units for RD are %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-7.86', 'ciUpperLimit': '6.39', 'pValueComment': 'P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff \\<= -12.5%.', 'groupDescription': 'Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set', 'statisticalMethod': '% Risk Difference (RD)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.', 'nonInferiorityComment': 'The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Clinical cure', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the 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'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Clinical cure', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end 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[{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI 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'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. 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Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Favorable', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}, {'title': 'Unfavorable', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". 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Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).'}, {'type': 'SECONDARY', 'title': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Favorable', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}, {'title': 'Unfavorable', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. 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[{'value': '355', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with at least one discharge', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': '1 discharge', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}, {'title': '2 discharges', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '>2 discharges', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 25 days from randomization', 'description': 'The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.'}, {'type': 'SECONDARY', 'title': 'The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'classes': [{'title': 'Number of patients with admission date', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}, {'title': 'Number of patients with at least one discharge', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}]}, {'title': '1 discharge', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}]}, {'title': '2 discharges', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '>2 discharges', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 25 days from randomization', 'description': 'The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'FG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '409'}, {'groupId': 'FG001', 'numSubjects': '408'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '355'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other Eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Overall, 879 patients were randomized in this study, from 4 geographic regions. The first patient was enrolled on 13 April 2013 and the last patient last visit was on 07 January 2016. Summary tables exclude 62 patients with moderate/severe renal impairment recruited prior to a protocol amendment to the dose regimen for such patients (MSRIBorig).', 'preAssignmentDetails': 'The first patient was enrolled on 13 April 2013 and the last patient last vist was on 07 January 2016. Overall, 969 patients were enrolled in this study, 90 of them screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '808', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CAZ-AVI', 'description': '2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem'}, {'id': 'BG001', 'title': 'Meropenem', 'description': 'meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '16.76', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '89'}, {'value': '61.7', 'spread': '17.57', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '90'}, {'value': '61.7', 'spread': '17.16', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-45', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}, {'title': '46-64', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}, {'title': '65-74', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}, {'title': '75-90', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics analysis is based on safety analysis set: randomized patients who received any amount of study therapy. 9 patients were randomized but not treated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 969}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2013-02-28', 'resultsFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2013-03-08', 'lastUpdatePostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-12-09', 'studyFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}], 'secondaryOutcomes': [{'measure': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.'}, {'measure': 'The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.'}, {'measure': 'Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'Per-patient "favorable" response indicates that all of the patient\'s baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set', 'timeFrame': 'Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.'}, {'measure': 'The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.'}, {'measure': 'The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.'}, {'measure': 'The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'At the test-of-cure (TOC) visit (Day 21 to 25)', 'description': 'The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.'}, {'measure': 'The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28', 'timeFrame': 'at Day 28 from randomization', 'description': 'The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.'}, {'measure': 'The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28', 'timeFrame': 'at Day 28 from randomization', 'description': 'The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.'}, {'measure': 'The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28', 'timeFrame': 'at Day 28 from randomization', 'description': 'The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.'}, {'measure': 'The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set', 'timeFrame': 'up to 25 days from randomization', 'description': 'The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.'}, {'measure': 'The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set', 'timeFrame': 'up to 25 days from randomization', 'description': 'The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.'}, {'measure': 'The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set', 'timeFrame': 'up to 25 days from randomization', 'description': 'The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ceftazidime,', 'Meropenem,', 'Anti-Bacterial Agents,', 'Anti-Infective Agents,', 'Therapeutic Uses,', 'Pharmacologic Actions,', 'Physiological Effects of Drugs'], 'conditions': ['Nosocomial Pneumonia (NP)', 'Ventilator-associated Pneumonia (VAP)']}, 'referencesModule': {'references': [{'pmid': '37700689', 'type': 'DERIVED', 'citation': 'Torres A, Wible M, Tawadrous M, Irani P, Stone GG, Quintana A, Debabov D, Burroughs M, Bradford PA, Kollef M. Efficacy and safety of ceftazidime/avibactam in patients with infections caused by beta-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme. J Antimicrob Chemother. 2023 Nov 6;78(11):2672-2682. doi: 10.1093/jac/dkad280.'}, {'pmid': '32602065', 'type': 'DERIVED', 'citation': 'Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.'}, {'pmid': '32349879', 'type': 'DERIVED', 'citation': 'Tichy E, Torres A, Bassetti M, Kongnakorn T, Di Virgilio R, Irani P, Charbonneau C. Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia, Including Ventilator-associated Pneumonia, in Italy. Clin Ther. 2020 May;42(5):802-817. doi: 10.1016/j.clinthera.2020.03.014. Epub 2020 Apr 27.'}, {'pmid': '32071051', 'type': 'DERIVED', 'citation': 'Stone GG, Bradford PA, Tawadrous M, Taylor D, Cadatal MJ, Chen Z, Chow JW. In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02356-19. doi: 10.1128/AAC.02356-19. Print 2020 Apr 21.'}, {'pmid': '30221827', 'type': 'DERIVED', 'citation': 'Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.'}, {'pmid': '30061279', 'type': 'DERIVED', 'citation': 'Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.'}, {'pmid': '29912399', 'type': 'DERIVED', 'citation': 'Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.'}, {'pmid': '29254862', 'type': 'DERIVED', 'citation': 'Torres A, Zhong N, Pachl J, Timsit JF, Kollef M, Chen Z, Song J, Taylor D, Laud PJ, Stone GG, Chow JW. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018 Mar;18(3):285-295. doi: 10.1016/S1473-3099(17)30747-8. Epub 2017 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia', 'detailedDescription': 'A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 to 90 years of age inclusive\n* Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after\n* Onset of symptoms ≥ 48 hours after admission or \\<7 days after discharge from an inpatient acute or chronic care facility\n* New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization\n* At least 1 of the following systemic signs:Fever (temperature \\>38 C) or hypothermia (rectal/core temperature \\<35 C); White blood cell count \\>10,000 cells/mm3, or White blood cell count \\<4500 cells/mm3, or \\>15% band forms.\n\nExclusion Criteria:\n\n* Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).\n* Patients with lung abscess, pleural empyema or post obstructive pneumonia.\n* Patients with an estimated creatinine clearance \\<16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.\n* Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.\n* Patients receiving hemodialysis or peritoneal dialysis."}, 'identificationModule': {'nctId': 'NCT01808092', 'briefTitle': 'A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults', 'orgStudyIdInfo': {'id': 'D4281C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAZ-AVI', 'description': 'Intra-Venous treatment', 'interventionNames': ['Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meropenem', 'description': 'Intra-Venous treatment', 'interventionNames': ['Drug: meropenem (active comparator)']}], 'interventions': [{'name': 'ceftazidim-avibactam (CAZ-AVI, experimental product)', 'type': 'DRUG', 'description': '2000mg ceftazidime plus 500mg avibactam', 'armGroupLabels': ['CAZ-AVI']}, {'name': 'meropenem (active comparator)', 'type': 'DRUG', 'description': '1000mg of Meropenem', 'armGroupLabels': ['Meropenem']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Florida', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.53258, 'lon': -58.49078}}, {'city': 'La Plata', 'country': 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