Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT02714595
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2016-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'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'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097602', 'term': 'Cefiderocol'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'shionogiclintrials-admin@shionogi.co.jp', 'phone': '800-849-9707', 'title': 'Shionogi Clinical Trials Administrator', 'organization': 'Shionogi Inc.'}, 'certainAgreement': {'otherDetails': "The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug up to 28 days after last dose; For patients with HAP/VAP/HCAP or BSI/sepsis median treatment duration was 11.0 (2-22) days (cefiderocol) and 13.0 (2-22) days (BAT); In patients with cUTI median treatment duration was 10.5 (2-29) days (cefiderocol) and 6.5 (2-14) days (BAT).', 'eventGroups': [{'id': 'EG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 88, 'seriousNumAtRisk': 101, 'deathsNumAffected': 34, 'seriousNumAffected': 50}, {'id': 'EG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 43, 'seriousNumAtRisk': 49, 'deathsNumAffected': 9, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pupils unequal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Biliary dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Gallbladder necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Acinetobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Candiduria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Catheter site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Corynebacterium infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Enterobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Enterococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oropharyngeal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 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{'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Neurological decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Quadriplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '33.8', 'upperLimit': '66.2'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '75.6'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '23.2', 'upperLimit': '65.5'}, {'value': '42.9', 'groupId': 'OG003', 'lowerLimit': '17.7', 'upperLimit': '71.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\nParticipants with missing data were considered as non-responders.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat (CR Micro-ITT) Population included all participants who received at least 1 dose of the study treatment, who had a baseline Gram-negative pathogen from an appropriate clinical specimen, and whose baseline Gram-negative pathogen was carbapenem-resistant as confirmed by central laboratory testing.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '77.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21', 'description': 'Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ colony-forming units (CFU)/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '43.3', 'upperLimit': '75.1'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '38.4', 'upperLimit': '83.7'}, {'value': '69.6', 'groupId': 'OG002', 'lowerLimit': '47.1', 'upperLimit': '86.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '23.0', 'upperLimit': '77.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '33.8', 'upperLimit': '66.2'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '56.6'}, {'value': '39.1', 'groupId': 'OG002', 'lowerLimit': '19.7', 'upperLimit': '61.5'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '58.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '89.7'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '93.2'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered as non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '77.0'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population); participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'Overall: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'Overall: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '75.3'}, {'value': '57.6', 'groupId': 'OG001', 'lowerLimit': '39.2', 'upperLimit': '74.5'}, {'value': '66.3', 'groupId': 'OG002', 'lowerLimit': '54.8', 'upperLimit': '76.4'}, {'value': '57.9', 'groupId': 'OG003', 'lowerLimit': '40.8', 'upperLimit': '73.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'Overall: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'Overall: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '60.6'}, {'value': '48.5', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '66.5'}, {'value': '52.5', 'groupId': 'OG002', 'lowerLimit': '41.0', 'upperLimit': '63.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '33.4', 'upperLimit': '66.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'Overall: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'Overall: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '59.1'}, {'value': '30.3', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '48.7'}, {'value': '47.5', 'groupId': 'OG002', 'lowerLimit': '36.2', 'upperLimit': '59.0'}, {'value': '34.2', 'groupId': 'OG003', 'lowerLimit': '19.6', 'upperLimit': '51.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.\n\ncUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '63.9', 'groupId': 'OG006'}, {'value': '58.8', 'groupId': 'OG007'}, {'value': '62.2', 'groupId': 'OG008'}, {'value': '58.8', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '69.2', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '64.7', 'groupId': 'OG008'}, {'value': '63.6', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '63.6', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '90.9', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '66.7', 'groupId': 'OG006'}, {'value': '55.6', 'groupId': 'OG007'}, {'value': '75.0', 'groupId': 'OG008'}, {'value': '58.3', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG008'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '44.4', 'groupId': 'OG006'}, {'value': '52.9', 'groupId': 'OG007'}, {'value': '43.2', 'groupId': 'OG008'}, {'value': '52.9', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '53.8', 'groupId': 'OG006'}, {'value': '55.6', 'groupId': 'OG007'}, {'value': '52.9', 'groupId': 'OG008'}, {'value': '54.5', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '81.8', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '57.1', 'groupId': 'OG006'}, {'value': '44.4', 'groupId': 'OG007'}, {'value': '65.6', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '60.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '44.4', 'groupId': 'OG006'}, {'value': '35.3', 'groupId': 'OG007'}, {'value': '43.2', 'groupId': 'OG008'}, {'value': '35.3', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '53.8', 'groupId': 'OG006'}, {'value': '55.6', 'groupId': 'OG007'}, {'value': '47.1', 'groupId': 'OG008'}, {'value': '27.3', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '63.6', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '52.4', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '56.3', 'groupId': 'OG008'}, {'value': '41.7', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '60.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.\n\ncUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '63.9', 'groupId': 'OG006'}, {'value': '58.8', 'groupId': 'OG007'}, {'value': '62.2', 'groupId': 'OG008'}, {'value': '58.8', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '90.9', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '68.8', 'groupId': 'OG006'}, {'value': '55.6', 'groupId': 'OG007'}, {'value': '77.8', 'groupId': 'OG008'}, {'value': '58.3', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '62.5', 'groupId': 'OG006'}, {'value': '62.5', 'groupId': 'OG007'}, {'value': '58.3', 'groupId': 'OG008'}, {'value': '60.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '44.4', 'groupId': 'OG006'}, {'value': '52.9', 'groupId': 'OG007'}, {'value': '43.2', 'groupId': 'OG008'}, {'value': '52.9', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '81.8', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '56.3', 'groupId': 'OG006'}, {'value': '44.4', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '62.5', 'groupId': 'OG006'}, {'value': '50.0', 'groupId': 'OG007'}, {'value': '58.3', 'groupId': 'OG008'}, {'value': '50.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '44.4', 'groupId': 'OG006'}, {'value': '35.3', 'groupId': 'OG007'}, {'value': '43.2', 'groupId': 'OG008'}, {'value': '35.3', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '63.6', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '55.6', 'groupId': 'OG008'}, {'value': '41.7', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '62.5', 'groupId': 'OG006'}, {'value': '25.0', 'groupId': 'OG007'}, {'value': '50.0', 'groupId': 'OG008'}, {'value': '30.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.\n\ncUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '46.5'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '51.2'}, {'value': '60.9', 'groupId': 'OG002', 'lowerLimit': '38.5', 'upperLimit': '80.3'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '58.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '38.5'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '45.6'}, {'value': '30.4', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '52.9'}, {'value': '28.6', 'groupId': 'OG003', 'lowerLimit': '8.4', 'upperLimit': '58.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '35.6'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '39.6'}, {'value': '26.1', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '48.4'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '50.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. If an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For sepsis, if the participant has a successful clinical outcome after TOC and an appropriate clinical culture could not be obtained, the response was presumed sustained eradication.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000', 'lowerLimit': '44.0', 'upperLimit': '89.7'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '67.1'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcome per Baseline pathogen at follow-up was determined by the sponsor as defined for each infection site.\n\nFor cUTI sustained eradication was defined as a culture taken any time after documented eradication at TOC and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\<10³ CFU/mL.\n\nOverall per-participant sustained eradication was defined as sustained eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'Overall: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'Overall: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '54.4'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '45.5'}, {'value': '47.5', 'groupId': 'OG002', 'lowerLimit': '36.2', 'upperLimit': '59.0'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '13.4', 'upperLimit': '43.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'Overall: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'Overall: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '37.9'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '42.3'}, {'value': '31.3', 'groupId': 'OG002', 'lowerLimit': '21.3', 'upperLimit': '42.6'}, {'value': '23.7', 'groupId': 'OG003', 'lowerLimit': '11.4', 'upperLimit': '40.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'Overall: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'Overall: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP, BSI/sepsis, or cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '34.5'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '35.5'}, {'value': '26.3', 'groupId': 'OG002', 'lowerLimit': '17.0', 'upperLimit': '37.3'}, {'value': '18.4', 'groupId': 'OG003', 'lowerLimit': '7.7', 'upperLimit': '34.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.\n\nFor HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\ncUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\< 10³ CFU/mL.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '41.7', 'groupId': 'OG006'}, {'value': '29.4', 'groupId': 'OG007'}, {'value': '40.5', 'groupId': 'OG008'}, {'value': '29.4', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '30.8', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '35.3', 'groupId': 'OG008'}, {'value': '36.4', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '72.7', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '81.8', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '61.9', 'groupId': 'OG006'}, {'value': '22.2', 'groupId': 'OG007'}, {'value': '68.8', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG008'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '27.8', 'groupId': 'OG006'}, {'value': '29.4', 'groupId': 'OG007'}, {'value': '27.0', 'groupId': 'OG008'}, {'value': '29.4', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '7.7', 'groupId': 'OG006'}, {'value': '11.1', 'groupId': 'OG007'}, {'value': '11.8', 'groupId': 'OG008'}, {'value': '18.2', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '54.5', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '72.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '38.1', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '50.0', 'groupId': 'OG008'}, {'value': '25.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '40.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '17.6', 'groupId': 'OG007'}, {'value': '24.3', 'groupId': 'OG008'}, {'value': '17.6', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '17', 'groupId': 'OG008'}, {'value': '11', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '7.7', 'groupId': 'OG006'}, {'value': '11.1', 'groupId': 'OG007'}, {'value': '5.9', 'groupId': 'OG008'}, {'value': '18.2', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '32', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '63.6', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '43.8', 'groupId': 'OG008'}, {'value': '25.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '40.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.\n\nFor HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\ncUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\< 10³ CFU/mL.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant Gram-negative pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '41.7', 'groupId': 'OG006'}, {'value': '29.4', 'groupId': 'OG007'}, {'value': '40.5', 'groupId': 'OG008'}, {'value': '29.4', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '81.8', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '56.3', 'groupId': 'OG006'}, {'value': '22.2', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '37.5', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '20.', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '27.8', 'groupId': 'OG006'}, {'value': '29.4', 'groupId': 'OG007'}, {'value': '27.0', 'groupId': 'OG008'}, {'value': '29.4', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '72.7', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '31.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '48.1', 'groupId': 'OG008'}, {'value': '25.0', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '25.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '12.5', 'groupId': 'OG007'}, {'value': '8.3', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Acinetobacter baumannii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '37', 'groupId': 'OG008'}, {'value': '17', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '17.6', 'groupId': 'OG007'}, {'value': '24.3', 'groupId': 'OG008'}, {'value': '17.6', 'groupId': 'OG009'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '63.6', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '40.7', 'groupId': 'OG008'}, {'value': '25.0', 'groupId': 'OG009'}]}]}, {'title': 'Pseudomonas aeruginosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '10', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '12.5', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}]}]}, {'title': 'Stenotrophomonas maltophilia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG008'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.\n\nFor HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\ncUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\< 10³ CFU/mL.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with the relevant carbapenem-resistant pathogen at Baseline; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '75.6'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture.', 'unitOfMeasure': 'percentge of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '53.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'The percentage of participants who experienced sustained eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture after TOC.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population with documented carbapenem-resistant Gram-negative bacteremia at Baseline (all infection sites combined); participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Composite Clinical and Microbiological Response at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '46.5'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '51.2'}, {'value': '56.5', 'groupId': 'OG002', 'lowerLimit': '34.5', 'upperLimit': '76.8'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '70.6', 'groupId': 'OG004', 'lowerLimit': '44.0', 'upperLimit': '89.7'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '39.7', 'groupId': 'OG006', 'lowerLimit': '27.6', 'upperLimit': '52.8'}, {'value': '24.2', 'groupId': 'OG007', 'lowerLimit': '11.1', 'upperLimit': '42.3'}, {'value': '46.3', 'groupId': 'OG008', 'lowerLimit': '35.0', 'upperLimit': '57.8'}, {'value': '23.7', 'groupId': 'OG009', 'lowerLimit': '11.4', 'upperLimit': '40.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Composite Clinical and Microbiological Response at TOC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '38.5'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '45.6'}, {'value': '30.4', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '52.9'}, {'value': '21.4', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '50.8'}, {'value': '47.1', 'groupId': 'OG004', 'lowerLimit': '23.0', 'upperLimit': '72.2'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '25.4', 'groupId': 'OG006', 'lowerLimit': '15.3', 'upperLimit': '37.9'}, {'value': '21.2', 'groupId': 'OG007', 'lowerLimit': '9.0', 'upperLimit': '38.9'}, {'value': '30.0', 'groupId': 'OG008', 'lowerLimit': '20.3', 'upperLimit': '41.3'}, {'value': '21.1', 'groupId': 'OG009', 'lowerLimit': '9.6', 'upperLimit': '37.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Composite Clinical and Microbiological Response at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '33', 'groupId': 'OG007'}, {'value': '80', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '35.6'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '39.6'}, {'value': '26.1', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '48.4'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '42.8'}, {'value': '41.2', 'groupId': 'OG004', 'lowerLimit': '18.4', 'upperLimit': '67.1'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '12.7', 'upperLimit': '34.5'}, {'value': '15.2', 'groupId': 'OG007', 'lowerLimit': '5.1', 'upperLimit': '31.9'}, {'value': '26.3', 'groupId': 'OG008', 'lowerLimit': '17.0', 'upperLimit': '37.3'}, {'value': '15.8', 'groupId': 'OG009', 'lowerLimit': '6.0', 'upperLimit': '31.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'The composite clinical and microbiological response rate is defined as the percentage of participants with both sustained clinical cure and sustained microbiologic eradication, as defined above for each site of infection.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality at Day 14 and Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '75', 'groupId': 'OG006'}, {'value': '39', 'groupId': 'OG007'}, {'value': '101', 'groupId': 'OG008'}, {'value': '49', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'HAP/VAP/HCAP + BSI/Sepsis: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP or BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG008', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG009', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '39.5'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '16.7', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '34.7'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '28.7'}, {'value': '11.5', 'groupId': 'OG004', 'lowerLimit': '2.4', 'upperLimit': '30.2'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '21.3', 'groupId': 'OG006', 'lowerLimit': '12.7', 'upperLimit': '32.3'}, {'value': '10.3', 'groupId': 'OG007', 'lowerLimit': '2.9', 'upperLimit': '24.2'}, {'value': '18.8', 'groupId': 'OG008', 'lowerLimit': '11.7', 'upperLimit': '27.8'}, {'value': '12.2', 'groupId': 'OG009', 'lowerLimit': '4.6', 'upperLimit': '24.8'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '31.1', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '46.6'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '23.3', 'groupId': 'OG002', 'lowerLimit': '9.9', 'upperLimit': '42.3'}, {'value': '17.6', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '43.4'}, {'value': '15.4', 'groupId': 'OG004', 'lowerLimit': '4.4', 'upperLimit': '34.9'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '55.6'}, {'value': '28.0', 'groupId': 'OG006', 'lowerLimit': '18.2', 'upperLimit': '39.6'}, {'value': '17.9', 'groupId': 'OG007', 'lowerLimit': '7.5', 'upperLimit': '33.5'}, {'value': '24.8', 'groupId': 'OG008', 'lowerLimit': '16.7', 'upperLimit': '34.3'}, {'value': '18.4', 'groupId': 'OG009', 'lowerLimit': '8.8', 'upperLimit': '32.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 and Day 28', 'description': 'The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants who experienced mortality regardless of the cause at or before Day 14 and Day 28, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population includes randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Alive and With No Change in Antibiotic Treatment Due to Either Lack of Therapeutic Benefit or Drug-related Toxicity at TOC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '73.1'}, {'value': '60.5', 'groupId': 'OG001', 'lowerLimit': '43.4', 'upperLimit': '76.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Days 1 to 10', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Days 11 to 20', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Days 21 to 30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Days 31 to 40', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Days 41 to 50', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Days 51 to 60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 1 to 10, 11 to 20, 21 to 30, 31 to 40, 41-50, and 51 to 60.', 'description': 'Survival time was analyzed by Kaplan-Meier survival curve. The table below presents deaths that occurred in10-day time intervals through the end of study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant Microbiological Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Test of cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (Day 7-14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28)', 'description': 'Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), and chest radiograph infiltrates. The total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality; a negative change from Baseline indicates improvement', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant microbiological intention-to-treat population; Participants with pneumonia and CPIS measurement at Baseline and at each post-baseline time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sequential Organ Failure Assessment (SOFA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}, {'value': '38', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'HAP/VAP/HCAP: Cefiderocol', 'description': 'Participants with HAP/VAP/HCAP received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'HAP/VAP/HCAP: Best Available Therapy', 'description': 'Participants with HAP/VAP/HCAP received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG002', 'title': 'BSI/Sepsis: Cefiderocol', 'description': 'Participants with BSI/sepsis received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG003', 'title': 'BSI/Sepsis: Best Available Therapy', 'description': 'Participants with BSI/sepsis received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG004', 'title': 'cUTI: Cefiderocol', 'description': 'Participants with cUTI received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG005', 'title': 'cUTI: Best Available Therapy', 'description': 'Participants with cUTI received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'OG006', 'title': 'Overall: Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG007', 'title': 'Overall: Best Available Therapy', 'description': 'Participants received best available therapy, as chosen by the investigator, which may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '35', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '2.8', 'groupId': 'OG003'}, {'value': '-0.6', 'spread': '1.3', 'groupId': 'OG004'}, {'value': '-1.3', 'spread': '2.3', 'groupId': 'OG005'}, {'value': '-1.1', 'spread': '3.3', 'groupId': 'OG006'}, {'value': '-1.0', 'spread': '2.7', 'groupId': 'OG007'}]}]}, {'title': 'Test of cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '56', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '4.1', 'groupId': 'OG003'}, {'value': '-0.6', 'spread': '2.0', 'groupId': 'OG004'}, {'value': '-1.3', 'spread': '2.3', 'groupId': 'OG005'}, {'value': '-1.3', 'spread': '3.8', 'groupId': 'OG006'}, {'value': '-0.9', 'spread': '3.4', 'groupId': 'OG007'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '54', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '4.4', 'groupId': 'OG003'}, {'value': '-0.1', 'spread': '2.5', 'groupId': 'OG004'}, {'value': '-2.0', 'spread': '3.5', 'groupId': 'OG005'}, {'value': '-1.9', 'spread': '3.8', 'groupId': 'OG006'}, {'value': '-1.4', 'spread': '3.5', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (Day 7 to 14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28)', 'description': "The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each score is from 0 to 4, and the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality. A negative change from Baseline score indicates improvement.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Carbapenem-resistant microbiological intention-to-treat population with SOFA measurement at Baseline and at each post-baseline time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'OG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Mild adverse events', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Moderate adverse events', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse events', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related adverse events', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations due to adverse events', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Discontinuations due to drug-related AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events (SAE)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Drug-related serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Death due to serious adverse events', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to 28 days after last dose; maximum treatment duration was 29 days in the cefiderocol group and 22 days in the BAT group.', 'description': 'The severity of each adverse event (AE) was graded by the investigator according to the following definitions:\n\n* Mild: Symptom or finding is minor and does not interfere with usual daily activities\n* Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status\n* Severe: The event causes interruption of usual daily activities or has a clinically significant effect\n\nThe relationship of AEs to study treatment was determined by the investigator according to the following definition:\n\n● Related: An AE which can be reasonably explained as having been caused by the study treatment.\n\nA serious AE is defined as any AE that resulted in any of the following outcomes:\n\n* Death\n* Life-threatening condition\n* Hospitalization or prolongation of existing hospitalization\n* Persistent or significant disability/incapacity\n* Congenital anomaly/birth defect\n* Other medically important condition', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'FG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Received Treatment', 'comment': 'Safety population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'Carbapenem-resistant Microbiological Intent-to-treat', 'comment': 'CR Micro-ITT population; See definition in Baseline Characteristics section', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Other-Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study enrolled hospitalized patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), bloodstream infection (BSI), sepsis, or complicated urinary tract infection (cUTI) caused by carbapenem-resistant Gram-negative pathogens, and was conducted at 95 sites in 16 countries.', 'preAssignmentDetails': 'Participants were randomized in a 2:1 ratio to receive therapy with cefiderocol or best available therapy (BAT), stratified by primary clinical diagnosis (HAP/VAP/HCAP, BSI/sepsis, cUTI), Acute Physiology and Chronic Health Evaluation (APACHE) II score (≤ 15 or ≥ 16-≤ 30), and region (North America, South America region, Europe, Asia-Pacific).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cefiderocol', 'description': 'Participants received 2 g cefiderocol administered intravenously over 3 hours, every 8 hours for 7-14 days.'}, {'id': 'BG001', 'title': 'Best Available Therapy (BAT)', 'description': 'Participants received best available therapy, as chosen by the investigator, and may have included up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.1', 'spread': '18.7', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '18.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': '< 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '≥ 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': 'North America', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'South America', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Europe', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Asia-Pacific', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total APACHE II Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': '≤ 15', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': '≥ 16', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Acute Physiology And Chronic Health Evaluation II is a severity-of-disease classification applied within 24 hours of admission of a patient to an intensive care unit (ICU). The APACHE II score consists of three parts: 12 acute physiological variables, age, and chronic health status. The range of the score is 0 to 71, where higher scores correspond to more severe disease and a higher risk of death.', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'title': 'HAP/VAP/HCAP', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'BSI/Sepsis', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'cUTI', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'BSI = bloodstream infection; cUTI = complicated urinary tract infection; HAP = hospital-acquired pneumonia; HCAP = healthcare-associated pneumonia; VAP = ventilator-associated pneumonia', 'unitOfMeasure': 'Participants'}, {'title': 'Sequential Organ Failure Assessment (SOFA) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '5.6', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each score is from 0 to 4, the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Pulmonary Infection Score (CPIS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) and chest radiograph infiltrates.\n\nThe total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only conducted in participants with HAP/VAP/HCAP; 2 participants had missing CPIS scores at Baseline.'}], 'populationDescription': 'The Carbapenem-resistant Microbiological Intent-to-treat (CR Micro-ITT) population includes randomized participants who received at least 1 dose of study drug and who had a central laboratory confirmed carbapenem resistant Gram-negative pathogen at Baseline from an appropriate clinical biospecimen.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-27', 'size': 634798, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-20T13:51', 'hasProtocol': False}, {'date': '2017-11-16', 'size': 1195067, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-20T16:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03780140', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2020-12', 'dispFirstSubmitDate': '2020-03-26', 'completionDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-18', 'studyFirstSubmitDate': '2016-02-26', 'dispFirstSubmitQcDate': '2020-03-26', 'resultsFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2016-03-15', 'dispFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-18', 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\nParticipants with missing data were considered as non-responders."}, {'measure': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI', 'timeFrame': 'Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21', 'description': 'Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ colony-forming units (CFU)/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen."}, {'measure': 'Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC."}, {'measure': 'Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC."}, {'measure': 'Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.\n\ncUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC."}, {'measure': 'Percentage of Participants With Clinical Cure at End of Treatment By Baseline Pathogen', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Clinical Cure at Test of Cure By Baseline Pathogen', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Pathogen', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.\n\ncUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC."}, {'measure': 'Percentage of Participants With Clinical Cure at EOT By Baseline Carbapenem-resistant Pathogen', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Clinical Cure at TOC By Baseline Carbapenem-resistant Pathogen', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis:\n\nHAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection.\n\nBSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen.\n\ncUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection."}, {'measure': 'Percentage of Participants With Sustained Clinical Cure at Follow-up By Baseline Carbapenem-resistant Pathogen', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': "Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis.\n\nSustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC.\n\nBSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC.\n\ncUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC."}, {'measure': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria established for each infection site:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen (sputum, tracheal aspirate, bronchoalveolar lavage (BAL) fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP or BSI/Sepsis', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC. If an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable. For sepsis, if the participant has a successful clinical outcome after TOC and an appropriate clinical culture could not be obtained, the response was presumed sustained eradication.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With cUTI', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With cUTI', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcome per Baseline pathogen at follow-up was determined by the sponsor as defined for each infection site.\n\nFor cUTI sustained eradication was defined as a culture taken any time after documented eradication at TOC and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\<10³ CFU/mL.\n\nOverall per-participant sustained eradication was defined as sustained eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.\n\nFor HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\ncUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\< 10³ CFU/mL.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at EOT By Baseline Pathogen', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at TOC By Baseline Pathogen', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcomes per Baseline pathogen were determined by the sponsor according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Pathogen', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.\n\nFor HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\ncUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\< 10³ CFU/mL.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at EOT By Baseline Carbapenem-resistant Pathogen', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at TOC By Baseline Carbapenem-resistant Pathogen', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'Microbiological outcome per Baseline carbapenem-resistant pathogen were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen. If it was not possible to obtain an appropriate clinical culture and the participant had a successful clinical outcome, the response was presumed to be eradication.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture and/or other primary source as applicable. In the case of sepsis, if the participant had a successful clinical outcome and it was not possible to obtain an appropriate clinical culture, the response was presumed to be eradication.\n\ncUTI: a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ CFU/mL was reduced to \\< 10³ CFU/mL.\n\nOverall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens.'}, {'measure': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up By Baseline Carbapenem-resistant Pathogen', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'Microbiological outcomes per Baseline pathogen at FU were determined according to the following criteria for each diagnosis:\n\nHAP/VAP/HCAP: Sustained eradication was defined as the absence of the Baseline Gram-negative pathogen from an appropriate clinical specimen after TOC.\n\nBSI/Sepsis: Absence of the Baseline Gram-negative pathogen from a blood culture or other primary source after TOC as applicable.\n\nFor HAP/VAP/HCAP and sepsis if an appropriate clinical culture could not be obtained and the participant had a successful clinical response after TOC, the response was presumed sustained eradication.\n\ncUTI: a culture taken any time after documented eradication at TOC, and a urine culture obtained at FU showed that the Baseline uropathogen found at entry at ≥10⁵ CFU/mL remained \\< 10³ CFU/mL.\n\nOverall per-participant response was defined as sustained eradication of all Baseline Gram-negative pathogens after documented eradication at TOC.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at EOT in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture.'}, {'measure': 'Percentage of Participants With Microbiologic Eradication at TOC in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'The percentage of participants who experienced eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture.'}, {'measure': 'Percentage of Participants With Sustained Microbiologic Eradication at Follow-up in Participants With Documented Carbapenem-resistant Gram-negative Bacteremia', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'The percentage of participants who experienced sustained eradication of the Baseline documented carbapenem-resistant Gram-negative bacteremia, defined as absence of the Baseline Gram-negative pathogen from a blood culture after TOC.'}, {'measure': 'Percentage of Participants With a Composite Clinical and Microbiological Response at EOT', 'timeFrame': 'End of treatment, Day 7 to 14', 'description': 'The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection.'}, {'measure': 'Percentage of Participants With a Composite Clinical and Microbiological Response at TOC', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21', 'description': 'The composite clinical and microbiological response rate is defined as the percentage of participants with both clinical cure and microbiologic eradication, as defined above for each site of infection.'}, {'measure': 'Percentage of Participants With a Composite Clinical and Microbiological Response at Follow-up', 'timeFrame': 'Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28', 'description': 'The composite clinical and microbiological response rate is defined as the percentage of participants with both sustained clinical cure and sustained microbiologic eradication, as defined above for each site of infection.'}, {'measure': 'All-cause Mortality at Day 14 and Day 28', 'timeFrame': 'Day 14 and Day 28', 'description': 'The all-cause mortality rate at Day 14 and Day 28 was calculated as the percentage of participants who experienced mortality regardless of the cause at or before Day 14 and Day 28, respectively.'}, {'measure': 'Percentage of Participants Alive and With No Change in Antibiotic Treatment Due to Either Lack of Therapeutic Benefit or Drug-related Toxicity at TOC', 'timeFrame': 'Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21'}, {'measure': 'Survival Time', 'timeFrame': 'Days 1 to 10, 11 to 20, 21 to 30, 31 to 40, 41-50, and 51 to 60.', 'description': 'Survival time was analyzed by Kaplan-Meier survival curve. The table below presents deaths that occurred in10-day time intervals through the end of study'}, {'measure': 'Change From Baseline in Clinical Pulmonary Infection Score (CPIS) in Participants With Pneumonia (HAP/VAP/HCAP)', 'timeFrame': 'Baseline, end of treatment (Day 7-14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28)', 'description': 'Clinical pulmonary infection score (CPIS) is a surrogate for diagnosis and treatment response. Points (0, 1, or 2) are assigned for observed findings for 5 variables including body temperature, white blood cell count, tracheal secretions, ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), and chest radiograph infiltrates. The total score ranges from 0 to 10, where higher scores may indicate a higher likelihood of mortality; a negative change from Baseline indicates improvement'}, {'measure': 'Change From Baseline in Sequential Organ Failure Assessment (SOFA)', 'timeFrame': 'Baseline, end of treatment (Day 7 to 14), test of cure (7 days after end of treatment, equivalent to Study Day 14 to 21) and follow-up (14 days after end of treatment, equivalent to Study Day 21 to 28)', 'description': "The SOFA score is a scoring system to determine the extent of a patient's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each score is from 0 to 4, and the total score ranges from 0 to 24, where higher scores indicate a higher likelihood of mortality. A negative change from Baseline score indicates improvement."}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose of study drug up to 28 days after last dose; maximum treatment duration was 29 days in the cefiderocol group and 22 days in the BAT group.', 'description': 'The severity of each adverse event (AE) was graded by the investigator according to the following definitions:\n\n* Mild: Symptom or finding is minor and does not interfere with usual daily activities\n* Moderate: The event causes discomfort and interferes with usual daily activity or affects clinical status\n* Severe: The event causes interruption of usual daily activities or has a clinically significant effect\n\nThe relationship of AEs to study treatment was determined by the investigator according to the following definition:\n\n● Related: An AE which can be reasonably explained as having been caused by the study treatment.\n\nA serious AE is defined as any AE that resulted in any of the following outcomes:\n\n* Death\n* Life-threatening condition\n* Hospitalization or prolongation of existing hospitalization\n* Persistent or significant disability/incapacity\n* Congenital anomaly/birth defect\n* Other medically important condition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cefiderocol', 'Bloodstream infections (BSI)', 'Complicated urinary tract infection (cUTI)', 'Ventilator associated pneumonia (VAP)', 'Hospital acquired pneumonia (HAP)', 'Sepsis', 'multi-drug resistant pathogens', 'S-649266', 'Gram-negative pathogens', 'Healthcare-associated pneumonia (HCAP)', 'carbapenem resistant pathogens'], 'conditions': ['Healthcare-associated Pneumonia (HCAP)', 'Bloodstream Infections (BSI)', 'Hospital Acquired Pneumonia (HAP)', 'Complicated Urinary Tract Infection (cUTI)', 'Sepsis', 'Ventilator Associated Pneumonia (VAP)']}, 'referencesModule': {'references': [{'pmid': '35076335', 'type': 'DERIVED', 'citation': 'Nordmann P, Shields RK, Doi Y, Takemura M, Echols R, Matsunaga Y, Yamano Y. Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials. Microb Drug Resist. 2022 Apr;28(4):398-407. doi: 10.1089/mdr.2021.0180. Epub 2022 Jan 24.'}, {'pmid': '34792787', 'type': 'DERIVED', 'citation': 'Wenzler E, Butler D, Tan X, Katsube T, Wajima T. Pharmacokinetics, Pharmacodynamics, and Dose Optimization of Cefiderocol during Continuous Renal Replacement Therapy. Clin Pharmacokinet. 2022 Apr;61(4):539-552. doi: 10.1007/s40262-021-01086-y. Epub 2021 Nov 18.'}, {'pmid': '33393598', 'type': 'DERIVED', 'citation': 'Naseer S, Weinstein EA, Rubin DB, Suvarna K, Wei X, Higgins K, Goodwin A, Jang SH, Iarikov D, Farley J, Nambiar S. US Food and Drug Administration (FDA): Benefit-Risk Considerations for Cefiderocol (Fetroja(R)). Clin Infect Dis. 2021 Jun 15;72(12):e1103-e1111. doi: 10.1093/cid/ciaa1799.'}, {'pmid': '33058795', 'type': 'DERIVED', 'citation': 'Bassetti M, Echols R, Matsunaga Y, Ariyasu M, Doi Y, Ferrer R, Lodise TP, Naas T, Niki Y, Paterson DL, Portsmouth S, Torre-Cisneros J, Toyoizumi K, Wunderink RG, Nagata TD. Efficacy and safety of cefiderocol or best available therapy for the treatment of serious infections caused by carbapenem-resistant Gram-negative bacteria (CREDIBLE-CR): a randomised, open-label, multicentre, pathogen-focused, descriptive, phase 3 trial. Lancet Infect Dis. 2021 Feb;21(2):226-240. doi: 10.1016/S1473-3099(20)30796-9. Epub 2020 Oct 12.'}, {'pmid': '31819544', 'type': 'DERIVED', 'citation': 'Bassetti M, Ariyasu M, Binkowitz B, Nagata TD, Echols RM, Matsunaga Y, Toyoizumi K, Doi Y. Designing A Pathogen-Focused Study To Address The High Unmet Medical Need Represented By Carbapenem-Resistant Gram-Negative Pathogens - The International, Multicenter, Randomized, Open-Label, Phase 3 CREDIBLE-CR Study. Infect Drug Resist. 2019 Nov 21;12:3607-3623. doi: 10.2147/IDR.S225553. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.', 'detailedDescription': 'This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients with either hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), complicated urinary tract infection (cUTI), or bloodstream infections (BSI)/sepsis caused by carbapenem-resistant Gram-negative pathogens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinically documented infection (HAP/VAP/HCAP, cUTI, or BSI/sepsis) caused by a Gram-negative pathogen with evidence of carbapenem resistance\n* Patients who have been treated previously with an empiric antibiotic regiment and failed treatment, both clinically and microbiologically, are eligible for the study, if they have an identified carbapenem-resistant Gram-negative pathogen which has either been shown to be nonsusceptible in vitro to each of the antibiotic(s) of the empiric antibiotic regimen or been grown from a culture performed after at least 2 days of the empiric antibiotic regimen\n* Patient is male (no contraception required) or female and meets one of the following criteria:\n\n * Surgically sterile by hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy or tubal ligation for the purpose of contraception for at least 6 weeks with appropriate documentation of such surgery\n * Postmenopausal (defined as older than 45 years of age with cessation of regular menstrual periods for 6 months and confirmed by a follicle-stimulating hormone level of \\> 40 mIU/mL, or amenorrhea for at least 12 months)\n * Of childbearing potential and using combined (estrogen and progestogen) or progestogen-only hormonal contraception associated with inhibition of ovulation (including oral, intravaginal, injectable, implantable, and transdermal contraceptives), or an intrauterine device (IUD), or intrauterine hormone-releasing system (IUS) for the entire duration of the study\n * Of childbearing potential and practice abstinence as a preferred and usual lifestyle, and agrees to continue practicing abstinence from Screening and for the entire duration of the study\n * Of childbearing potential, whose sole heterosexual partner has been successfully vasectomized and agrees to not have other heterosexual partners for the entire duration of the study\n* Patients meeting specific criteria for each infection site\n\nExclusion Criteria:\n\n1. Patients who have a history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam (Note: for β-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment)\n2. Patients who need more than 3 systemic antibiotics as part of best available therapy (BAT) for the treatment of the Gram-negative infection (patients with mixed Gram-positive or anaerobic infections may receive appropriate concomitant narrow spectrum antibiotics \\[eg, vancomycin, linezolid, metronidazole, clindamycin\\])\n3. Patients with coinfection caused by invasive aspergillosis, mucormycosis or other highly lethal mold\n4. Patients who have central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection)\n5. Patients with infection requiring \\> 3 weeks of antibiotic treatment (eg, bone and joint infection, endocarditis)\n6. Patients with cystic fibrosis or moderate to severe bronchiectasis\n7. Patients in refractory septic shock defined as persistent hypotension despite adequate fluid resuscitation or despite vasopressive therapy at the time of Randomization\n8. Patients with severe neutropenia, ie, polymorphonuclear neutrophils (PMNs) \\< 100 cells/μL\n9. Female patients who have a positive pregnancy test at Screening or who are lactating\n10. Patients with Acute Physiology and Chronic Health Evaluation II (APACHE II) score \\> 30\n11. Patients who have received a potentially effective antibiotic regimen for the carbapenem-resistant Gram-negative infection for a continuous duration of more than 24 hours in cUTI, or 36 hours in HAP/VAP/HCAP or BSI/sepsis during the 72 hours leading to Randomization\n12. Patients with any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data\n13. Patients who have received another investigational drug or device within 30 days prior to study entry\n14. Patients who have previously been randomized in this study or received S-649266\n15. Patients receiving peritoneal dialysis\n16. Patients meeting specific exclusion criteria for each infection site'}, 'identificationModule': {'nctId': 'NCT02714595', 'acronym': 'CREDIBLE - CR', 'briefTitle': 'Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shionogi Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens', 'orgStudyIdInfo': {'id': '1424R2131'}, 'secondaryIdInfos': [{'id': '2015-004703-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefiderocol', 'description': 'Participants will receive cefiderocol 2 g administered intravenously over 3 hours, every 8 hours for 7-14 days. Treatment could be extended to 21 days at the discretion of the investigator.', 'interventionNames': ['Drug: Cefiderocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Available Therapy (BAT)', 'description': 'Best available therapy (BAT) will be chosen by the investigator and may include up to three antibacterial agents for carbapenem resistant Gram-negative bacteria, intravenously administered per country-specific guidelines for 7-14 days. Treatment could be extended to 21 days at the discretion of the investigator.', 'interventionNames': ['Drug: Best Available Therapy']}], 'interventions': [{'name': 'Cefiderocol', 'type': 'DRUG', 'otherNames': ['S-649266', 'Fetroja ®'], 'description': '2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days, or 2 g every 6 hours for participants with creatinine clearance \\>120 mL/min.', 'armGroupLabels': ['Cefiderocol']}, {'name': 'Best Available Therapy', 'type': 'DRUG', 'description': 'Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s).', 'armGroupLabels': ['Best Available Therapy (BAT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '41810-011', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '80050', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '99010-080', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'zip': '90035-074', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '97105-900', 'city': 'Santa Maria', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Shionogi Research Site', 'geoPoint': {'lat': -29.68417, 'lon': -53.80694}}, {'zip': '15090', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 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