Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-26 @ 4:15 PM
Study NCT ID:
NCT02019420
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Austria', 'Belarus', 'Belgium', 'Bosnia and Herzegovina', 'Brazil', 'Canada', 'Chile', 'China', 'Colombia', 'Croatia', 'Czechia', 'Estonia', 'France', 'Georgia', 'Germany', 'Greece', 'Guatemala', 'Hong Kong', 'Hungary', 'Israel', 'Japan', 'Jordan', 'Kazakhstan', 'Latvia', 'Lebanon', 'Malaysia', 'Mexico', 'New Zealand', 'Peru', 'Philippines', 'Portugal', 'Puerto Rico', 'Russia', 'Serbia', 'Slovakia', 'South Africa', 'South Korea', 'Spain', 'Sri Lanka', 'Switzerland', 'Taiwan', 'Thailand', 'Turkey (Türkiye)', 'Ukraine', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515040', 'term': 'tedizolid phosphate'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Cubist intends to pursue publication of the results of the study in cooperation with a lead Investigator, subject to the terms and conditions of the clinical study agreement between Cubist and Investigators. Cubist approval in writing is required for publication of any data subsets.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 32 days', 'description': 'All participants who received any amount of study drug are included. The safety assessment is based on actual treatment received, and thus the linezolid arm includes 4 participants randomized to tedizolid who received the wrong treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.', 'otherNumAtRisk': 357, 'deathsNumAtRisk': 357, 'otherNumAffected': 176, 'seriousNumAtRisk': 357, 'deathsNumAffected': 101, 'seriousNumAffected': 129}, {'id': 'EG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.', 'otherNumAtRisk': 361, 'deathsNumAtRisk': 361, 'otherNumAffected': 175, 'seriousNumAtRisk': 361, 'deathsNumAffected': 103, 'seriousNumAffected': 149}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 66, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 52, 'numAffected': 51}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 31, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 36, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 52, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 49, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Duodenal 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'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pancreatic necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peritoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumatosis intestinalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Brain death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acinetobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Brain abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'CNS ventriculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Endotoxaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Endotoxic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Enterobacter pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, 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'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Laryngospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pharyngeal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pleural thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Penile ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neurogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 357, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 361, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in all-cause mortality', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '4.7', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI \\> -10.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set is all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in all-cause mortality', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '7.1', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in mITT all-cause mortality (linezolid - tedizolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if methicillin-resistant S. aureus \\[MRSA\\]) before first study drug dose, and bacterial pathogen against which the investigational drug has antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'title': 'Clinical Success', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Failure', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical success', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.6', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '-0.5', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in ITT clinical success (tedizolid - linezolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': "The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set includes all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'title': 'Clinical Success', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Failure', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical success', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.5', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '2.1', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in CE clinical success (tedizolid - linezolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': "The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The CE set is all randomized and treated participants who had assessment data available and did not have confounding events.'}, {'type': 'SECONDARY', 'title': 'Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in all-cause mortality', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-12.5', 'ciUpperLimit': '9.5', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MSSA-infected mITT set is all randomized, treated participants who have MSSA confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in all-cause mortality', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-12.8', 'ciUpperLimit': '18.9', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 28 days', 'description': 'The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MRSA-infected mITT set is all randomized, treated participants who have MRSA confirmed by respiratory tract/pleural fluid culture results obtained within 72 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical success', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '-4.5', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in mITT favorable response (tedizolid - linezolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-3 days after completing study therapy (Days 8-10 or Days 15-17)', 'description': 'The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical success', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '-4.5', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in ME-1 favorable response (tedizolid - linezolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-3 days after completing study therapy (Days 8-10 or Days 15-17)', 'description': 'The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME-1 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to 28 days after randomization.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical success', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-21.5', 'ciUpperLimit': '-3.5', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in mITT favorable response (tedizolid - linezolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': 'The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in clinical success', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.7', 'ciLowerLimit': '-26.2', 'ciUpperLimit': '-1.2', 'estimateComment': 'Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in ME-2 favorable response (tedizolid - linezolid)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': 'The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME-2 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to the TOC visit and is also in the clinically-evaluable (CE) set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥1 Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '327', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 32 days', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'OG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 days', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis was based on actual treatment received and not randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'FG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}, {'groupId': 'FG001', 'numSubjects': '360'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '361'}, {'groupId': 'FG001', 'numSubjects': '357'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}, {'groupId': 'FG001', 'numSubjects': '254'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Did not receive study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'At request of sponsor or investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'Transferred to other care facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) were enrolled at study sites located in 34 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '726', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tedizolid', 'description': 'Ventilated HABP/VABP participants received tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.'}, {'id': 'BG001', 'title': 'Linezolid', 'description': 'Ventilated HABP/VABP participants received linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '18.41', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '17.44', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '17.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '290', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '579', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '527', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-10', 'size': 1386927, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-10T09:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-10', 'studyFirstSubmitDate': '2013-12-18', 'resultsFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2013-12-18', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-10', 'studyFirstPostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population', 'timeFrame': 'Up to 28 days', 'description': 'The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population', 'timeFrame': 'Up to 28 days', 'description': 'The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.'}, {'measure': 'Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': "The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP."}, {'measure': 'Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': "The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP."}, {'measure': 'Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population', 'timeFrame': 'Up to 28 days', 'description': 'The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.'}, {'measure': 'Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population', 'timeFrame': 'Up to 28 days', 'description': 'The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.'}, {'measure': 'Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population', 'timeFrame': '1-3 days after completing study therapy (Days 8-10 or Days 15-17)', 'description': 'The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).'}, {'measure': 'Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population', 'timeFrame': '1-3 days after completing study therapy (Days 8-10 or Days 15-17)', 'description': 'The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).'}, {'measure': 'Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': 'The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).'}, {'measure': 'Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population', 'timeFrame': '7-14 days after end of therapy - TOC', 'description': 'The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).'}, {'measure': 'Number of Participants With ≥1 Adverse Events (AEs)', 'timeFrame': 'Up to 32 days', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization.'}, {'measure': 'Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)', 'timeFrame': 'Up to 14 days', 'description': 'An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis was based on actual treatment received and not randomization.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '16600048', 'type': 'BACKGROUND', 'citation': 'Alp E, Voss A. Ventilator associated pneumonia and infection control. Ann Clin Microbiol Antimicrob. 2006 Apr 6;5:7. doi: 10.1186/1476-0711-5-7.'}, {'pmid': '15699079', 'type': 'BACKGROUND', 'citation': 'American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.'}, {'pmid': '14625336', 'type': 'BACKGROUND', 'citation': 'Chastre J, Wolff M, Fagon JY, Chevret S, Thomas F, Wermert D, Clementi E, Gonzalez J, Jusserand D, Asfar P, Perrin D, Fieux F, Aubas S; PneumA Trial Group. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588.'}, {'pmid': '3390511', 'type': 'BACKGROUND', 'citation': 'Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics. 1988 Jun;44(2):579-85.'}, {'pmid': '16652315', 'type': 'BACKGROUND', 'citation': 'Lawrence KR, Adra M, Gillman PK. Serotonin toxicity associated with the use of linezolid: a review of postmarketing data. Clin Infect Dis. 2006 Jun 1;42(11):1578-83. doi: 10.1086/503839. Epub 2006 Apr 27.'}, {'pmid': '19759040', 'type': 'BACKGROUND', 'citation': 'Lemaire S, Van Bambeke F, Appelbaum PC, Tulkens PM. Cellular pharmacokinetics and intracellular activity of torezolid (TR-700): studies with human macrophage (THP-1) and endothelial (HUVEC) cell lines. J Antimicrob Chemother. 2009 Nov;64(5):1035-43. doi: 10.1093/jac/dkp267. Epub 2009 Sep 16.'}, {'pmid': '18989656', 'type': 'BACKGROUND', 'citation': 'Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7.'}, {'pmid': '21911576', 'type': 'BACKGROUND', 'citation': 'Drusano GL, Liu W, Kulawy R, Louie A. Impact of granulocytes on the antimicrobial effect of tedizolid in a mouse thigh infection model. Antimicrob Agents Chemother. 2011 Nov;55(11):5300-5. doi: 10.1128/AAC.00502-11. Epub 2011 Sep 12.'}, {'pmid': '21555763', 'type': 'BACKGROUND', 'citation': 'Garonzik SM, Li J, Thamlikitkul V, Paterson DL, Shoham S, Jacob J, Silveira FP, Forrest A, Nation RL. Population pharmacokinetics of colistin methanesulfonate and formed colistin in critically ill patients from a multicenter study provide dosing suggestions for various categories of patients. Antimicrob Agents Chemother. 2011 Jul;55(7):3284-94. doi: 10.1128/AAC.01733-10. Epub 2011 May 9.'}, {'pmid': '21217178', 'type': 'BACKGROUND', 'citation': 'Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children: executive summary. Clin Infect Dis. 2011 Feb 1;52(3):285-92. doi: 10.1093/cid/cir034.'}, {'pmid': '21163725', 'type': 'BACKGROUND', 'citation': 'Pletz MW, Burkhardt O, Welte T. Nosocomial methicillin-resistant Staphylococcus aureus (MRSA) pneumonia: linezolid or vancomycin? - Comparison of pharmacology and clinical efficacy. Eur J Med Res. 2010 Nov 30;15(12):507-13. doi: 10.1186/2047-783x-15-12-507.'}, {'pmid': '22354302', 'type': 'BACKGROUND', 'citation': 'Tessier PR, Keel RA, Hagihara M, Crandon JL, Nicolau DP. Comparative in vivo efficacies of epithelial lining fluid exposures of tedizolid, linezolid, and vancomycin for methicillin-resistant Staphylococcus aureus in a mouse pneumonia model. Antimicrob Agents Chemother. 2012 May;56(5):2342-6. doi: 10.1128/AAC.06427-11. Epub 2012 Feb 21.'}, {'pmid': '22247123', 'type': 'BACKGROUND', 'citation': 'Wunderink RG, Niederman MS, Kollef MH, Shorr AF, Kunkel MJ, Baruch A, McGee WT, Reisman A, Chastre J. Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study. Clin Infect Dis. 2012 Mar 1;54(5):621-9. doi: 10.1093/cid/cir895. Epub 2012 Jan 12.'}, {'pmid': '35718656', 'type': 'DERIVED', 'citation': 'Mikamo H, Nagashima M, Kusachi S, Fujimi S, Oshima N, De Anda C, Takase A. Efficacy and safety of tedizolid for the treatment of ventilated gram-positive hospital-acquired or ventilator-associated bacterial pneumonia in Japanese patients: Results from a subgroup analysis of a phase 3, randomized, double-blind study comparing tedizolid and linezolid. J Infect Chemother. 2022 Sep;28(9):1235-1241. doi: 10.1016/j.jiac.2022.04.027. Epub 2022 Jun 16.'}, {'pmid': '33720350', 'type': 'DERIVED', 'citation': 'Wunderink RG, Roquilly A, Croce M, Rodriguez Gonzalez D, Fujimi S, Butterton JR, Broyde N, Popejoy MW, Kim JY, De Anda C. A Phase 3, Randomized, Double-Blind Study Comparing Tedizolid Phosphate and Linezolid for Treatment of Ventilated Gram-Positive Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia. Clin Infect Dis. 2021 Aug 2;73(3):e710-e718. doi: 10.1093/cid/ciab032.'}]}, 'descriptionModule': {'briefSummary': 'This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.\n\nThe primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM) within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI \\> -10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia\n* Gram-positive bacteria on respiratory Gram stain\n\nExclusion Criteria:\n\n* Pneumonia of community, viral, fungal or parasitic etiology\n* Structural lung abnormalities\n* Immunosuppression\n* Previous antibiotics for \\> 24 hours\n* Expected survival of \\< 72 hours'}, 'identificationModule': {'nctId': 'NCT02019420', 'briefTitle': 'Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia', 'orgStudyIdInfo': {'id': '1986-002'}, 'secondaryIdInfos': [{'id': 'TR701-132', 'type': 'OTHER', 'domain': 'Cubist Protocol Number'}, {'id': '2013-004154-22', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-1986-002', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tedizolid phosphate IV', 'description': 'Ventilated HABP/VABP participants receive tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.', 'interventionNames': ['Drug: Tedizolid phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Linezolid IV', 'description': 'Ventilated HABP/VABP participants receive linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Tedizolid phosphate', 'type': 'DRUG', 'otherNames': ['SIVEXTRO®', 'TR-701 FA', 'MK-1986'], 'description': 'Tedizolid phosphate IV 200 mg once daily', 'armGroupLabels': ['Tedizolid phosphate IV']}, {'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['ZYVOX®'], 'description': 'Linezolid IV 600 mg twice daily', 'armGroupLabels': ['Linezolid IV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}