Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT03176134
Status:
COMPLETED
Last Update Posted:
2025-07-31
First Post:
2017-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C515040', 'term': 'tedizolid phosphate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 35 days', 'description': 'All-cause mortality was reported on all randomized participants. Serious and non-serious AEs were reported on all randomized participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 4, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 7, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Viral diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 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0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 35 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \\<28 Days Neonates) and Cohort 4: Comparator (Birth to \\<28 Days Term \\& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately day 15', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. The number of participants who discontinued study treatment due to an AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \\<28 Days Neonates) and Cohort 4: Comparator (Birth to \\<28 Days Term \\& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hematopoietic Cytopenias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 35 days', 'description': 'Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \\<28 Days Neonates) and Cohort 4: Comparator (Birth to \\<28 Days Term \\& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response (CR) Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '75', 'groupId': 'OG006'}, {'value': '25', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG006', 'title': 'All Cohorts: Tedizolid Phosphate', 'description': 'Participants in Cohort 1 (age: 6 to \\<12 years), Cohort 2 (age: 2 to \\<6 years), and Cohort 3 (age: 28 days to \\<2 years) received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG007', 'title': 'All Cohorts: Comparator', 'description': 'Participants in Cohort 1 (age: 6 to \\<12 years), Cohort 2 (age: 2 to \\<6 years), and Cohort 3 (age: 28 days to \\<2 years) received comparator IV and/or oral per local standard of care for 10 to 14 days.'}], 'classes': [{'title': 'Clinical Success', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000', 'lowerLimit': '81.3', 'upperLimit': '98.6'}, {'value': '86.7', 'groupId': 'OG001', 'lowerLimit': '59.5', 'upperLimit': '98.3'}, {'value': '87.5', 'groupId': 'OG002', 'lowerLimit': '61.7', 'upperLimit': '98.4'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '93.3', 'groupId': 'OG006', 'lowerLimit': '85.1', 'upperLimit': '97.8'}, {'value': '92.0', 'groupId': 'OG007', 'lowerLimit': '74.0', 'upperLimit': '99.0'}]}]}, {'title': 'Clinical Failure or Indeterminate', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '40.5'}, {'value': '12.5', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '38.3'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '6.7', 'groupId': 'OG006', 'lowerLimit': '2.2', 'upperLimit': '14.9'}, {'value': '8.0', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '26.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '-12.2', 'ciUpperLimit': '25.3', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.5', 'ciLowerLimit': '-28.7', 'ciUpperLimit': '3.7', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '13.4', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 25 days', 'description': 'CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \\& symptoms, absence/near resolution of regional/systemic signs of infection if present at baseline (BL) \\& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event (TEAE) leading to study drug discontinuation \\& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \\& 3 \\& all cohorts together were reported, \\& failure \\& indeterminate responses were pooled.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study intervention. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \\<28 Days Neonates) and Cohort 4: Comparator (Birth to \\<28 Days Term \\& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.'}, {'type': 'SECONDARY', 'title': 'Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '68', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'OG006', 'title': 'All Cohorts: Tedizolid Phosphate', 'description': 'Participants in Cohort 1 (age: 6 to \\<12 years), Cohort 2 (age: 2 to \\<6 years), and Cohort 3 (age: 28 days to \\<2 years) received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'OG007', 'title': 'All Cohorts: Comparator', 'description': 'Participants in Cohort 1 (age: 6 to \\<12 years), Cohort 2 (age: 2 to \\<6 years), and Cohort 3 (age: 28 days to \\<2 years) received comparator IV and/or oral per local standard of care for 10 to 14 days.'}], 'classes': [{'title': 'Clinical Success', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '76.8', 'upperLimit': '100.0'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '78.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '47.8', 'upperLimit': '100.0'}, {'value': '100.00', 'groupId': 'OG006', 'lowerLimit': '94.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG007', 'lowerLimit': '85.2', 'upperLimit': '100.0'}]}]}, {'title': 'Clinical Failure or Indeterminate', 'categories': [{'measurements': [{'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.0', 'comment': 'NA = Lower limit and upper limit of 95%CI were not calculated due to insufficient number of participants with response.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% confidence interval (CI) were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG006', 'OG007'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '0.0', 'estimateComment': 'The estimated difference in the clinical success rate and 2-sided 95% CI were calculated using the unstratified method of Miettinen and Nurminen.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 25 days', 'description': 'CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \\& symptoms, absence/near resolution of regional/systemic signs of infection if present at BL \\& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event leading to study drug discontinuation \\& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \\& 3 and all cohorts together were reported, \\& failure \\& indeterminate responses were pooled.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'CE participants included all randomized participants who received at least one dose of study intervention, had a confirmed ABSSSI, had a suspected or documented gram+ infection from BL, received a sufficient course of therapy. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \\<28 Days Neonates) and Cohort 4: Comparator (Birth to \\<28 Days Term \\& preterm neonates) arms. So, cohort 4 arms were not included in the analysis per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'FG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'FG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'FG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'FG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'FG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'FG006', 'title': 'Cohort 4: Tedizolid Phosphate Birth to <28 Days Term and Preterm Neonates', 'description': 'Participants were to receive Tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose was to be determined based on results of another study (NCT03217565) covering the age range. No participants were enrolled in this arm.'}, {'id': 'FG007', 'title': 'Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates', 'description': 'Participants were to receive comparator IV and/or oral as per local standard of care for 10-14 days. No participants were enrolled in this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of100 participants were randomized and received treatment and were evaluable for all safety and efficacy analyses. No participants were enrolled for Cohort 4: Tedizolid phosphate (Birth to \\<28 Days Neonates) and Cohort 4: Comparator (Birth to \\<28 Days Term \\& preterm neonates) arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '100', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: Tedizolid Phosphate 6 to <12 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'BG001', 'title': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'BG002', 'title': 'Cohort 2: Tedizolid Phosphate 2 to <6 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'BG003', 'title': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'BG004', 'title': 'Cohort 3: Tedizolid Phosphate 28 Days to <2 Years', 'description': 'Participants received tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight ≥30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.'}, {'id': 'BG005', 'title': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants received comparator IV and/or oral per local standard of care for 10 to 14 days.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '3.4', 'spread': '1.1', 'groupId': 'BG003'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'BG004'}, {'value': '1.0', 'spread': '0.1', 'groupId': 'BG005'}, {'value': '6.0', 'spread': '3.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '53', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '83', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '80', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-27', 'size': 1461092, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-10T08:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2017-06-01', 'resultsFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-10', 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 35 days', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an AE', 'timeFrame': 'Up to approximately day 15', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. The number of participants who discontinued study treatment due to an AE were reported.'}, {'measure': 'Number of Participants With Hematopoietic Cytopenias', 'timeFrame': 'Up to approximately 35 days', 'description': 'Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Response (CR) Per Investigator Assessment', 'timeFrame': 'Up to approximately 25 days', 'description': 'CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \\& symptoms, absence/near resolution of regional/systemic signs of infection if present at baseline (BL) \\& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event (TEAE) leading to study drug discontinuation \\& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \\& 3 \\& all cohorts together were reported, \\& failure \\& indeterminate responses were pooled.'}, {'measure': 'Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment', 'timeFrame': 'Up to approximately 25 days', 'description': 'CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \\& symptoms, absence/near resolution of regional/systemic signs of infection if present at BL \\& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event leading to study drug discontinuation \\& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \\& 3 and all cohorts together were reported, \\& failure \\& indeterminate responses were pooled.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Bacterial Skin and Skin Structure Infections']}, 'referencesModule': {'references': [{'pmid': '40233296', 'type': 'RESULT', 'citation': 'Mngqibisa R, Fofanov O, Grazioso CF, Melgar Toledo M, Boddicker M, Broyde N, Koseoglu S, Romero L, Stevens M, Sears P. A Phase 3 Study of the Safety and Efficacy of Tedizolid Phosphate in Patients <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections. Pediatr Infect Dis J. 2025 Jun 1;44(6):533-538. doi: 10.1097/INF.0000000000004807. Epub 2025 Apr 14.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26090&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).', 'detailedDescription': 'Participants will be randomized (3:1) to receive tedizolid phosphate at a weight-based dose ≤200 mg/day, intravenous (IV) and/or oral suspension for 6 to 10 days, or comparator IV and/or oral per local standard of care for 10 to 14 days. The switch from IV to oral administration can be made at any time based on 1) no worsening of the primary skin lesion, 2) last temperature \\<37.7 °C, and 3) primary acute bacterial skin and skin structure infection (ABSSSI) site has not worsened and at least 1 site has improved from Baseline. The potential 4-day treatment extension will be based on clinical need as judged by the investigator, considering the following criteria: 1) ≥40% reduction in primary lesion size, 2) reduction in pain, and 3) no new signs and symptoms and no complications attributable to ABSSSI compared with Baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a parent/legally acceptable representative who is able to give documented informed consent\n* Has acute bacterial skin and skin structure infections (ABSSSI), defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection\n* Local symptoms of ABSSSI that started within 14 days before study start\n* Suspected or documented Gram-positive bacterial infection\n\nExclusion Criteria:\n\n* Uncomplicated skin and skin structure infection\n* ABSSSI due to or associated with disallowed etiology per protocol\n* Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) \\<48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy\n* Known bacteremia, severe sepsis, or septic shock\n* Significant or life-threatening condition, disease, or organ system condition\n* Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens\n* Received or is receiving treatment for active tuberculosis within 1 month of study start\n* Known or suspected severe neutropenia\n* Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count \\<15% (HIV testing is not required for eligibility)\n* Renal impairment that requires renal filtration\n* Severe hepatic impairment\n* Cardiac or electrocardiogram (ECG) finding that would limit participation in the study\n* Received an investigational medicinal product (not approved) within 30 days before study start\n* Investigational device present or removed within 30 days before study start\n* Previously treated with tedizolid phosphate\n* Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation\n* Contraindication, including hypersensitivity to all available comparator drugs\n* Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required\n* Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the end of treatment (EOT) visit, is allowed, as is administration during treatment with IV drug)\n* Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent\n* Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans)\n* Identified as having used illicit drugs (urine drug screening not required for entry)'}, 'identificationModule': {'nctId': 'NCT03176134', 'briefTitle': 'A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)', 'orgStudyIdInfo': {'id': '1986-018'}, 'secondaryIdInfos': [{'id': 'MK-1986-018', 'type': 'OTHER', 'domain': 'MSD Protocol Number'}, {'id': '2016-003884-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Tedizolid phosphate 6 to <12 Years', 'description': 'Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.', 'interventionNames': ['Drug: Tedizolid phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1: Comparator 6 to <12 Years', 'description': 'Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.', 'interventionNames': ['Drug: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Tedizolid phosphate 2 to <6 Years', 'description': 'Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.', 'interventionNames': ['Drug: Tedizolid phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2: Comparator 2 to <6 Years', 'description': 'Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.', 'interventionNames': ['Drug: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Tedizolid phosphate 28 Days to <2 Years', 'description': 'Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to \\<50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to \\<30 kg), by IV and/or oral suspension for 6 to 10 days.', 'interventionNames': ['Drug: Tedizolid phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 3: Comparator 28 Days to <2 Years', 'description': 'Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.', 'interventionNames': ['Drug: Comparator']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates', 'description': 'Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study (NCT03217565) covering the age range.', 'interventionNames': ['Drug: Tedizolid phosphate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates', 'description': 'Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days.', 'interventionNames': ['Drug: Comparator']}], 'interventions': [{'name': 'Tedizolid phosphate', 'type': 'DRUG', 'otherNames': ['MK-1986', 'TR-701 FA'], 'description': 'Tedizolid phosphate IV solution or oral suspension', 'armGroupLabels': ['Cohort 1: Tedizolid phosphate 6 to <12 Years', 'Cohort 2: Tedizolid phosphate 2 to <6 Years', 'Cohort 3: Tedizolid phosphate 28 Days to <2 Years', 'Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates']}, {'name': 'Comparator', 'type': 'DRUG', 'description': 'Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care', 'armGroupLabels': ['Cohort 1: Comparator 6 to <12 Years', 'Cohort 2: Comparator 2 to <6 Years', 'Cohort 3: Comparator 28 Days to <2 Years', 'Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital-San Diego ( Site 0118)", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. 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