Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-03-09 @ 1:58 AM
Study NCT ID:
NCT03788967
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2018-12-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C500135', 'term': 'tebipenem'}, {'id': 'D000077727', 'term': 'Ertapenem'}], 'ancestors': [{'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'atalley@sperotherapeutics.com', 'phone': '857-242-1575', 'title': 'Angela Talley', 'organization': 'Senior Vice President Clinical Development'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 45 days to preserve intellectual property', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days)', 'description': 'Safety analysis population included all randomized participants who received any amount of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.', 'otherNumAtRisk': 685, 'deathsNumAtRisk': 685, 'otherNumAffected': 39, 'seriousNumAtRisk': 685, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.', 'otherNumAtRisk': 687, 'deathsNumAtRisk': 687, 'otherNumAffected': 30, 'seriousNumAtRisk': 687, 'deathsNumAffected': 0, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}], 'seriousEvents': [{'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Duodenal ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Retroperitoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Procedural pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Clostridium test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Generalized tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Acute pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 685, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 687, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-9.7', 'ciUpperLimit': '3.2', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority hypothesis test was a 1-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in overall response was greater than -12.5%, non-inferiority was declared.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '687', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days)', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all randomized participants who received any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '1.9', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiologically evaluable (ME) - TOC is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the evaluability review plan (ERP).'}, {'type': 'SECONDARY', 'title': 'Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'EOT', 'categories': [{'measurements': [{'value': '446', 'groupId': 'OG000'}, {'value': '410', 'groupId': 'OG001'}]}]}, {'title': 'TOC', 'categories': [{'measurements': [{'value': '418', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}]}]}, {'title': 'LFU', 'categories': [{'measurements': [{'value': '398', 'groupId': 'OG000'}, {'value': '377', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '3.4', 'groupDescription': 'Statistical Analysis 1 (EOT)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4', 'ciUpperLimit': '2.8', 'groupDescription': 'Statistical Analysis 2 (TOC)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '2.6', 'groupDescription': 'Statistical Analysis 3 (LFU)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological intent-to-treat population (Micro-ITT) included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.'}, {'type': 'SECONDARY', 'title': 'Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '677', 'groupId': 'OG000'}, {'value': '674', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '673', 'groupId': 'OG000'}, {'value': '665', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.0', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (EOT)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE-EOT population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at EOT.'}, {'type': 'SECONDARY', 'title': 'Clinical Cure at TOC in the CE-TOC Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '641', 'groupId': 'OG000'}, {'value': '637', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '617', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '0.6', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 19 (TOC)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE-TOC population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at TOC.'}, {'type': 'SECONDARY', 'title': 'Sustained Clinical Cure at LFU in the CE-LFU Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '596', 'groupId': 'OG000'}, {'value': '596', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '556', 'groupId': 'OG000'}, {'value': '559', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '2.3', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 25 (LFU)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE-LFU population is a subset which included participants who meet the definition for the ITT population, have no important protocol deviations that would affect the assessment of efficacy, and had an outcome assessed as clinical cure or clinical failure at LFU.'}, {'type': 'SECONDARY', 'title': 'Clinical Cure at EOT in the ME-EOT Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '437', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.2', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (EOT)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.'}, {'type': 'SECONDARY', 'title': 'Clinical Cure at TOC Days in the ME-TOC Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '0.8', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 19 (TOC)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ME-TOC population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.'}, {'type': 'SECONDARY', 'title': 'Sustained Clinical Cure at LFU in the ME-LFU Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '360', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '2.6', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 25 (LFU)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ME-LFU population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.'}, {'type': 'SECONDARY', 'title': 'By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'EOT', 'categories': [{'measurements': [{'value': '439', 'groupId': 'OG000'}, {'value': '403', 'groupId': 'OG001'}]}]}, {'title': 'TOC', 'categories': [{'measurements': [{'value': '267', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}, {'title': 'LFU', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '4.1', 'groupDescription': 'Statistical Analysis 1 (EOT)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.5', 'ciLowerLimit': '-10.8', 'ciUpperLimit': '1.9', 'groupDescription': 'Statistical Analysis 2 (TOC)', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-7.9', 'ciUpperLimit': '5', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 15 (EOT), 19 (TOC) and 25 (LFU)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication is defined as number of participants with reduction of Baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at Baseline. Sustained Microbiological Eradication is defined as number of participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT include all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.'}, {'type': 'SECONDARY', 'title': 'By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Enterobacterales, Citrobacter braakii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter freundii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter amnigenus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter asburiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter bugandensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}, {'value': '96.7', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '98.6', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus hauseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus penneri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus hirae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Gram Positive, Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Staphylococcus lugdunensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Staphylococcus saprophyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Streptococcus gallolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 15 (EOT)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.', 'unitOfMeasure': 'percentage of pathogen eradication', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pathogens', 'denomUnitsSelected': 'Pathogens', 'populationDescription': 'Micro-ITT-all randomized participants with confirmed diagnosis of cUTI/AP and positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall Number of Units Analyzed=number of pathogens available for analysis at given timepoint. Participant may have had more than 1 pathogen. Multiple isolates of same species/category from same participant are counted only once towards total.'}, {'type': 'SECONDARY', 'title': 'By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '493', 'groupId': 'OG000'}, {'value': '455', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Enterobacterales, Citrobacter braakii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter freundii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter amnigenus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter asburiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter bugandensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000'}, {'value': '65.2', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}, {'value': '63.4', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus hauseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus penneri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus hirae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Gram Positive, Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Staphylococcus lugdunensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Staphylococcus saprophyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Streptococcus gallolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 19 (TOC)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.', 'unitOfMeasure': 'percentage of pathogen eradication', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pathogens', 'denomUnitsSelected': 'Pathogens', 'populationDescription': 'Micro-ITT included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed are the number of pathogens available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Citrobacter braakii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter freundii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter amnigenus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter asburiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter bugandensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus hirae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000'}, {'value': '60.6', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Proteus hauseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000'}, {'value': '60.9', 'groupId': 'OG001'}]}]}, {'title': 'Proteus penneri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus lugdunensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus saprophyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus gallolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 25 (LFU)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined as microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.', 'unitOfMeasure': 'percentage of pathogen eradication', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pathogens', 'denomUnitsSelected': 'Pathogens', 'populationDescription': 'mITT-all randomized participants with confirmed diagnosis of cUTI/AP \\& positive Screening urine culture defined as growth of one/two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall Number of Units Analyzed are number of enterobacterale pathogens. Participant may have more than 1 pathogen. Multiple isolates of same species/category from same participants are counted once towards total.'}, {'type': 'SECONDARY', 'title': 'By-Patient Microbiological Eradication at EOT in the ME-EOT Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.2', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (EOT)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ME-EOT population is a subset which included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.'}, {'type': 'SECONDARY', 'title': 'By-Patient Microbiological Eradication at TOC in the ME-TOC Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.9', 'ciLowerLimit': '-12.4', 'ciUpperLimit': '0.7', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 15 (TOC)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ME-TOC population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP.'}, {'type': 'SECONDARY', 'title': 'By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '5.3', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 25 (LFU)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ME-LFU population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP'}, {'type': 'SECONDARY', 'title': 'By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '481', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Enterobacterales, Citrobacter braakii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter freundii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter amnigenus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter asburiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter bugandensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus hauseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus penneri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus hirae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Gram Positive, Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Staphylococcus lugdunensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive,Staphylococcus saprophyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Streptococcus gallolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 (EOT)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.', 'unitOfMeasure': 'percentage of pathogen eradication', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pathogens', 'denomUnitsSelected': 'Pathogens', 'populationDescription': 'ME-EOT population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Number analyzed are the number of pathogens available for analysis at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '408', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Enterobacterales, Citrobacter braakii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter freundii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter amnigenus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter asburiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter bugandensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus hauseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '76.2', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus penneri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enterobacterales, Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacterales, Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}, {'value': '57.6', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Enterococcus hirae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Gram Positive, Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Staphylococcus lugdunensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive,Staphylococcus saprophyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}, {'title': 'Gram Positive, Streptococcus gallolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 19 (TOC)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of participants analyzed.', 'unitOfMeasure': 'percentage of pathogen eradication', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pathogens', 'denomUnitsSelected': 'Pathogens', 'populationDescription': 'ME-EOT population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Number analyzed are the number of pathogens available for analysis at the given timepoint. A participant may have had more than 1 pathogen. Multiple isolates of the same species/category from the same participants are counted only once towards total.'}, {'type': 'SECONDARY', 'title': 'By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Citrobacter braakii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter freundii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Citrobacter koseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter amnigenus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter asburiae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter bugandensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterobacter cloacae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus faecalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '52.9', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus faecium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Enterococcus hirae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Escherichia coli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}, {'value': '61.8', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella aerogenes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Klebsiella oxytoca', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '68.4', 'groupId': 'OG001'}]}]}, {'title': 'Klebsiella variicola', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Morganella morganii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Proteus hauseri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Proteus mirabilis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Proteus penneri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Proteus vulgaris', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Providencia rettgeri', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Providencia stuartii', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Raoultella ornithinolytica', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Serratia liquefaciens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Serratia marcescens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus aureus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': '1Staphylococcus lugdunensis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus saprophyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}]}]}, {'title': 'Staphylococcus gallolyticus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'units': 'Pathogens', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 25 (LFU)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL.Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.', 'unitOfMeasure': 'percentage of pathogens eradications', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pathogens', 'denomUnitsSelected': 'Pathogens', 'populationDescription': 'ME-LFU population included participants who met the definitions of both the micro-ITT Population and CE Population and were defined for each visit for the analyses in the ME Population at each respective visit as outlined in the ERP. Overall Number of Units Analyzed are the number of enterobacteral pathogens. A participant may have had more than 1 pathogen. Multiple isolates of the same species/category from the same participants are counted only once towards total.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'AP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000'}, {'value': '70.6', 'groupId': 'OG001'}]}]}, {'title': 'cUTI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '53.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '4.1', 'groupDescription': 'Overall response for participants with AP', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-11.0', 'ciUpperLimit': '7.7', 'groupDescription': 'Overall response in participants with cUTI', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed are the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': '≥18 to <65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}]}]}, {'title': '≥65 to <75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '57.6', 'groupId': 'OG001'}]}]}, {'title': '≥75 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '9.9', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.4', 'ciLowerLimit': '-20.6', 'ciUpperLimit': '3.8', 'groupDescription': '≥65 to \\<75 years', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.5', 'ciLowerLimit': '-23.8', 'ciUpperLimit': '8.7', 'groupDescription': '≥75 years', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed is number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Central and Eastern Europe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '62.0', 'groupId': 'OG001'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-9.6', 'ciUpperLimit': '3.5', 'groupDescription': 'Central and Eastern Europe', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 25 (LFU)', 'description': 'Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. The point estimate and confidence interval (CI) is presented for Central and eastern Europe subgroup.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Number analyzed is number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Time (Days) to Resolution or Improvement of Signs and Symptoms of cUTI and AP Present a Baseline in the Micro-ITT Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 25 (LFU)', 'description': 'Time (days) to resolution or improvement of signs and symptoms of cUTI and AP present at baseline was defined as follows: date of the first visit at which all baseline signs/symptoms have improved by at least 1 grade with worsening of none and development of no new signs/symptoms of the index infection minus the date of randomization.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥105 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.'}, {'type': 'SECONDARY', 'title': 'Time (Days) to Defervescence in Micro-ITT Population With a Documented Fever at Screening or Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.736', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 25 (LFU)', 'description': 'Time to Defervescence (days) = date of first post-baseline temperature measure with maximum daily Temperature ≤38°C at the date of randomization.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens. Overall number of participants analyzed are the participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Rate of Clinical Relapse at the LFU Days in the Micro-ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 25 (LFU)', 'description': 'Clinical relapse is participants who met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at the LFU Visit and the subject requires antibiotic therapy for the cUT. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.'}, {'type': 'SECONDARY', 'title': 'Rates Of Superinfection And New Infection In The Micro-ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '449', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'OG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'classes': [{'title': 'Superinfection', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'New Infection', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 25 (LFU)', 'description': 'Superinfection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original Baseline pathogen\\[s\\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the investigator as a clinical failure) during the period up to and including EOT. New infection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original baseline pathogen\\[s\\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the Investigator as a clinical failure) in the period after EOT.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT population included all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vss) at Steady State in TBPM-PI-HBr Recipients in the Pharmacokinetic (PK) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '89.9'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '89.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.'}, {'type': 'SECONDARY', 'title': 'Cmax in TBPM-PI-HBr Recipients in the PK Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '7.01', 'groupId': 'OG000', 'lowerLimit': '2.05', 'upperLimit': '17.2'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '7.21', 'groupId': 'OG000', 'lowerLimit': '2.11', 'upperLimit': '18.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3', 'unitOfMeasure': 'microgram per milliliter (μg/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.'}, {'type': 'SECONDARY', 'title': 'Area Under Curve (AUC 0-24) in TBPM-PI-HBr Recipients in the PK Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '243'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '318'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3', 'unitOfMeasure': 'microgram.hour per milliliter (μg•h/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included participants treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.'}, {'type': 'SECONDARY', 'title': 'Minimum Concentration (Cmin) in TBPM-PI-HBr Recipients in the PK Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.706', 'groupId': 'OG000', 'lowerLimit': '0.000913', 'upperLimit': '4.89'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '0.000877', 'upperLimit': '8.44'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included subjects treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.'}, {'type': 'SECONDARY', 'title': 'Systemic Clearance (CL) in TBPM-PI-HBr Recipients in the PK Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '5.65', 'upperLimit': '65.3'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '31.6', 'groupId': 'OG000', 'lowerLimit': '5.65', 'upperLimit': '65.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3', 'unitOfMeasure': 'Litre per hour (L/h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included subjects treated with at least 1 dose of TBPM-PI-HBr with at least 1 analyzable plasma or urine PK sample. The data is reported only for TBPM-PI-HBr arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'FG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '685'}, {'groupId': 'FG001', 'numSubjects': '687'}]}, {'type': 'Micro-Intent-to-Treat (ITT) Population', 'comment': 'Micro-ITT=all randomized participants with a confirmed diagnosis of cUTI or AP and a positive Screening urine culture defined as growth of one or two uropathogens at ≥10\\^5 CFU/mL and/or positive Screening blood culture with isolation of one or more uropathogens.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}, {'groupId': 'FG001', 'numSubjects': '419'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '653'}, {'groupId': 'FG001', 'numSubjects': '663'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Participant Non-Compliance/Uncooperativeness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Participant Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COVID-19', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 95 study centers in Bulgaria, Czech Republic, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine, and the United States from 03 June 2019 to 27 May 2020.', 'preAssignmentDetails': 'Participants with diagnosis of complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) were enrolled to receive tebipenem pivoxil hydrobromide (TBPM-PI-HBr) and ertapenem.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'BG000'}, {'value': '687', 'groupId': 'BG001'}, {'value': '1372', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.'}, {'id': 'BG001', 'title': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '18.68', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '18.23', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '18.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '368', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '757', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '317', 'groupId': 'BG000'}, {'value': '298', 'groupId': 'BG001'}, {'value': '615', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '672', 'groupId': 'BG000'}, {'value': '682', 'groupId': 'BG001'}, {'value': '1354', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', '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': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '676', 'groupId': 'BG000'}, {'value': '677', 'groupId': 'BG001'}, {'value': '1353', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all randomized participants who received any amount of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-26', 'size': 1260167, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-13T06:49', 'hasProtocol': True}, {'date': '2020-09-03', 'size': 7016445, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-13T06:50', 'hasProtocol': False}]}}, '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': 1372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2021-05-07', 'completionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2018-12-22', 'dispFirstSubmitQcDate': '2022-06-27', 'resultsFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2018-12-26', 'dispFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-27', 'studyFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population', 'timeFrame': 'From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days)', 'description': 'An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product.'}], 'secondaryOutcomes': [{'measure': 'Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.'}, {'measure': 'Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations', 'timeFrame': 'Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.'}, {'measure': 'Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations', 'timeFrame': 'Day 15 (EOT)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.'}, {'measure': 'Clinical Cure at TOC in the CE-TOC Populations', 'timeFrame': 'Day 19 (TOC)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.'}, {'measure': 'Sustained Clinical Cure at LFU in the CE-LFU Populations', 'timeFrame': 'Day 25 (LFU)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.'}, {'measure': 'Clinical Cure at EOT in the ME-EOT Populations', 'timeFrame': 'Day 15 (EOT)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.'}, {'measure': 'Clinical Cure at TOC Days in the ME-TOC Populations', 'timeFrame': 'Day 19 (TOC)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.'}, {'measure': 'Sustained Clinical Cure at LFU in the ME-LFU Population', 'timeFrame': 'Day 25 (LFU)', 'description': 'Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU.'}, {'measure': 'By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population', 'timeFrame': 'Days 15 (EOT), 19 (TOC) and 25 (LFU)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication is defined as number of participants with reduction of Baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at Baseline. Sustained Microbiological Eradication is defined as number of participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL.'}, {'measure': 'By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population', 'timeFrame': 'Days 15 (EOT)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.'}, {'measure': 'By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population', 'timeFrame': 'Day 19 (TOC)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.'}, {'measure': 'By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT)', 'timeFrame': 'Day 25 (LFU)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined as microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.'}, {'measure': 'By-Patient Microbiological Eradication at EOT in the ME-EOT Populations', 'timeFrame': 'Day 15 (EOT)', 'description': 'Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.'}, {'measure': 'By-Patient Microbiological Eradication at TOC in the ME-TOC Population', 'timeFrame': 'Day 15 (TOC)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.'}, {'measure': 'By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations', 'timeFrame': 'Day 25 (LFU)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL.'}, {'measure': 'By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations', 'timeFrame': 'Day 15 (EOT)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed.'}, {'measure': 'By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations', 'timeFrame': 'Day 19 (TOC)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of participants analyzed.'}, {'measure': 'By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations', 'timeFrame': 'Day 25 (LFU)', 'description': 'Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\\^5 CFU/mL.Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed.'}, {'measure': 'Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) In Subgroup Including: Stratified Infection Category', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.'}, {'measure': 'Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Stratified Age Category', 'timeFrame': 'Day 19 (TOC)', 'description': 'Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline.'}, {'measure': 'Overall Response Rate (Combined Clinical Cure Plus Microbiological Eradication) at TOC In Subgroup Including Region', 'timeFrame': 'Day 25 (LFU)', 'description': 'Overall response rate is percentage of participants with combined clinical cure plus microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \\<10\\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. The point estimate and confidence interval (CI) is presented for Central and eastern Europe subgroup.'}, {'measure': 'Time (Days) to Resolution or Improvement of Signs and Symptoms of cUTI and AP Present a Baseline in the Micro-ITT Populations', 'timeFrame': 'Day 25 (LFU)', 'description': 'Time (days) to resolution or improvement of signs and symptoms of cUTI and AP present at baseline was defined as follows: date of the first visit at which all baseline signs/symptoms have improved by at least 1 grade with worsening of none and development of no new signs/symptoms of the index infection minus the date of randomization.'}, {'measure': 'Time (Days) to Defervescence in Micro-ITT Population With a Documented Fever at Screening or Day 1', 'timeFrame': 'Day 25 (LFU)', 'description': 'Time to Defervescence (days) = date of first post-baseline temperature measure with maximum daily Temperature ≤38°C at the date of randomization.'}, {'measure': 'Rate of Clinical Relapse at the LFU Days in the Micro-ITT Population', 'timeFrame': 'Day 25 (LFU)', 'description': 'Clinical relapse is participants who met criteria for clinical cure at TOC, but new signs and symptoms of cUTI or AP are present at the LFU Visit and the subject requires antibiotic therapy for the cUT. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.'}, {'measure': 'Rates Of Superinfection And New Infection In The Micro-ITT Population', 'timeFrame': 'Day 25 (LFU)', 'description': 'Superinfection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original Baseline pathogen\\[s\\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the investigator as a clinical failure) during the period up to and including EOT. New infection was isolation of a new uropathogen at ≥105 CFU/mL (other than the original baseline pathogen\\[s\\] from blood and/or urine) from a urine culture that was accompanied by clinical signs and symptoms of infection requiring alternative antimicrobial therapy (e.g., the participant was assessed by the Investigator as a clinical failure) in the period after EOT.'}, {'measure': 'Apparent Volume of Distribution (Vss) at Steady State in TBPM-PI-HBr Recipients in the Pharmacokinetic (PK) Population', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3'}, {'measure': 'Cmax in TBPM-PI-HBr Recipients in the PK Population', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3'}, {'measure': 'Area Under Curve (AUC 0-24) in TBPM-PI-HBr Recipients in the PK Population', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3'}, {'measure': 'Minimum Concentration (Cmin) in TBPM-PI-HBr Recipients in the PK Population', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3'}, {'measure': 'Systemic Clearance (CL) in TBPM-PI-HBr Recipients in the PK Population', 'timeFrame': 'Predose and post-dose at 0.25h, 0.5h, 1h, 2h, and 8h on Days 1 and 3'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complicated Urinary Tract Infection', 'Acute Pyelonephritis'], 'conditions': ['Complicated Urinary Tract Infection', 'Acute Pyelonephritis']}, 'referencesModule': {'references': [{'pmid': '35388666', 'type': 'DERIVED', 'citation': 'Eckburg PB, Muir L, Critchley IA, Walpole S, Kwak H, Phelan AM, Moore G, Jain A, Keutzer T, Dane A, Melnick D, Talley AK. Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection. N Engl J Med. 2022 Apr 7;386(14):1327-1338. doi: 10.1056/NEJMoa2105462.'}]}, 'descriptionModule': {'briefSummary': 'The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Male and female participants at least 18 years of age.\n2. Able to provide informed consent.\n3. Able to ingest oral tablets for the anticipated treatment duration. If present at baseline, nausea and/or vomiting should have been mild or well-controlled with antiemetic therapy, in order to tolerate oral study drug.\n4. Have a diagnosis of cUTI or AP as defined below:\n\n a. cUTI definition:\n\n At least Two of the following signs and symptoms:\n\n i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature \\>38.0°C \\[\\>100.4°F\\])\n\n ii. Dysuria, urgency to void, or increased urinary frequency\n\n iii. Nausea or vomiting, as reported by the participants\n\n iv. Lower abdominal, suprapubic, or pelvic pain\n\n And at least One of the following risk factors for cUTI:\n\n i. Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents, or other urinary tract prosthetic material), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters that have been in place for \\>24 hours prior to Screening must be removed or replaced prior to collection of the Screening urine for urinalysis and culture, unless removal or replacement is considered unsafe or contraindicated).\n\n ii. Current known functional or anatomical abnormality of the urogenital tract, including anatomic abnormalities of the urinary tract, neurogenic bladder, or post-void residual urine volume of ≥ 100 mL within the past 6 months.\n\n iii. Complete or partial obstructive uropathy (e.g., nephrolithiasis, tumor, fibrosis, urethral stricture) that is expected to be medically or surgically treated during study drug therapy (prior to end of the treatment \\[EOT\\]).\n\n iv. Known intrinsic renal disease with blood urea nitrogen (BUN) \\>20 mg/deciliter (dL), or blood urea \\>42.8 mg/dL, or serum creatinine (Cr) \\>1.4 mg/dL.\n\n v. Urinary retention, including urinary retention in men due to previously diagnosed benign prostatic hyperplasia (BPH).\n\n b. AP definition: Acute flank pain (onset within 7 days prior to randomization) or costovertebral angle tenderness on physical examination.\n\n And at least One of the following signs and symptoms:\n\n i. Chills, rigors, or fever; fever must be observed and documented by a health care provider (oral, tympanic, rectal or core temperature \\>38.0°C \\[\\>100.4°F\\]).\n\n ii. Peripheral white blood cell count (WBC) \\>10,000/mm3 or bandemia (≥15% immature polymorphonuclear neutrophils (PMNs), regardless of WBC count).\n\n iii. Nausea or vomiting, as reported by the participants.\n\n iv. Dysuria, urgency to void, or increased urinary frequency.\n\n Note: Participants who meet the definition for cUTI (Inclusion Criterion 4a) and also have flank pain or costovertebral tenderness should be randomized as cUTI rather than AP.\n5. Have an adequate urine specimen for evaluation and culture obtained within 24 h prior to randomization with evidence of pyuria that includes at least one of the following:\n\n 1. At least 10 WBCs per high power field (hpf) in urine sediment.\n 2. At least 10 WBCs per cubic millimeter (mm3) in unspun (non-centrifuged) urine.\n 3. Positive leukocyte esterase (LE) on urinalysis. Note: Participants could be randomized and administered investigational product (IP) prior to knowledge of urine culture results.\n6. Expectation, in the judgment of the Investigator, that the participant would survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study.\n7. Willing to comply with all the study activities and procedures throughout the duration of the study.\n8. Participants were required to use a highly-effective method of birth control; male participants were required to use an effective barrier method of contraception from Screening through LFU and for 90 days following the last dose if sexually active with a female of childbearing potential (FOCP); female participants must not have been pregnant or nursing, and were required to commit to either sexual abstinence or use at least two medically accepted, effective methods of birth control (e.g., condom, spermicidal gel, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) from Screening through LFU and for 90 days following the last dose.\n\nExclusion Criteria\n\n1. Presence of any known or suspected disease or condition that, in the opinion of the Investigator, may have confounded the assessment of efficacy, including but not limited to the following:\n\n 1. Perinephric or renal corticomedullary abscess.\n 2. Uncomplicated urinary tract infection (cUTI) - (acute cystitis that does not meet the cUTI disease definition, see Inclusion Criterion 4a).\n 3. Polycystic kidney disease.\n 4. Recent history of trauma to the pelvis or urinary tract.\n 5. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis.\n 6. Chronic vesicoureteral reflux.\n 7. Previous or planned renal transplantation.\n 8. Previous or planned cystectomy or ileal loop surgery.\n 9. Known or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia).\n 10. Confirmed or suspected infection that is caused by a pathogen that is resistant to either IP (e.g., carbapenem-resistant pathogen), including infection caused by fungi (e.g., candiduria) or mycobacteria (e.g., urogenital tuberculosis).\n2. Gross hematuria requiring intervention other than administration of IP or removal/placement of urinary tract instrumentation.\n3. Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required relieving an obstruction or placing urinary tract instrumentation).\n4. Creatinine clearance (CrCl) of ≤30 mL/min, as estimated by the Cockcroft-Gault formula:\n\n estimated Creatinine Clearance (eC\\_Cr) \\[mL/min\\]=((140-Age \\[yrs\\]) × Body Weight \\[kg\\] × \\[0.85 if Female\\])/(72 × Serum Creatinine \\[mg⁄dL\\]).\n5. Anticipated concomitant use of non-study antibacterial drug therapy between randomization and the LFU Visit that would potentially effect outcome evaluations of cUTI/ AP, including but not limited to antibacterials with potential activity versus uropathogens, antibacterial drug prophylaxis, and antibacterial bladder irrigation.\n6. Anticipated concomitant use of gastric acid-reducing medications between randomization and end-of-treatment (EOT), including proton pump inhibitors, histamine-2 receptor antagonists, and antacids.\n7. Receipt of more than a single dose of a short-acting potentially effective antibiotic started within 72 h prior to randomization.\n\n Exception: Participants who received more than a single dose of short-acting potentially effective antibiotic within 72 h prior to randomization may be eligible for enrollment if they meet all of the following criteria:\n 1. In the opinion of the Investigator they have failed the prior antibiotic therapy (e.g., have worsening signs and symptoms of cUTI/AP).\n 2. Had a documented uropathogen (growth in urine culture \\>10\\^5 CFU/mL) that is resistant to the prior antibiotic therapy.\n 3. Had a documented uropathogen that is carbapenem-susceptible.\n 4. Received approval from the Medical Monitor to enroll the participants.\n8. Severe hepatic impairment at Screening, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>5x upper limit of normal (ULN) or total bilirubin \\>3x ULN, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy).\n9. Any signs of severe sepsis, including shock or profound hypotension defined as systolic blood pressure \\<90 mmHg or a decrease of \\>40 mmHg from baseline that is not responsive to fluid challenge.\n10. Pregnant or breastfeeding women.\n11. History of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures).\n12. Receipt of any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to randomization.\n13. Known history of human immunodeficiency virus (HIV) infection and or acquired immunodeficiency syndrome (AIDS)-defining illness, or known history of HIV infection and known CD4 count \\<200/mm\\^3 within the past year.\n14. Presence of immunodeficiency or an immunocompromised condition including neutropenia (\\<1,000 neutrophils/mm\\^3 obtained from the local laboratory at Screening), hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term use of systemic corticosteroids (e.g., ≥20 mg/day of prednisone or systemic equivalent for at least 2 weeks).\n15. A mean QT interval corrected using Fridericia's formula (QTcF) \\>480 msec based on triplicate ECGs at Screening.\n16. History of significant hypersensitivity or allergic reaction to β-lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems), product excipients (mannitol, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and Opadry®) or any contraindication to the use of ertapenem.\n17. History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia)\n18. Requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and EOT.\n19. Unable or unwilling to comply with the protocol.\n20. An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator."}, 'identificationModule': {'nctId': 'NCT03788967', 'acronym': 'ADAPT-PO', 'briefTitle': 'Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spero Therapeutics'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)', 'orgStudyIdInfo': {'id': 'SPR994-301'}, 'secondaryIdInfos': [{'id': '2018-003671-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TBPM-PI-HBr 600 mg', 'description': 'TBPM-PI-HBr 600 mg (300 mg×2 ) film-coated tablets, administered orally three times per day (every 8 hours \\[q8h\\] ± 0.5 h) plus a single dummy IV infusion over 30 minutes (min) once daily (every 24 hours \\[q24h\\] ± 0.5 h) up to Day 15; participants with moderate renal insufficiency (creatinine clearance \\[CrCl\\] \\>30 to ≤50 mL/min) required TBPM-PI-HBr dosage adjustment to 300 mg (one tablet) q8h ± 0.5 h.', 'interventionNames': ['Drug: TBPM-PI-HBr', 'Drug: Dummy Infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ertapenem 1 g', 'description': 'Ertapenem for IV injection, administered as a 1-gram IV infusion over 30 min once daily (q24h ± 0.5 h) plus dummy placebo tablets administered orally q8h (±0.5 h) up to Day 14; no dose adjustment of ertapenem was required for participants with renal insufficiency.', 'interventionNames': ['Drug: Ertapenem', 'Drug: Dummy tablets']}], 'interventions': [{'name': 'TBPM-PI-HBr', 'type': 'DRUG', 'otherNames': ['SPR994'], 'description': 'TBPM-PI-HBr tablets administered orally.', 'armGroupLabels': ['TBPM-PI-HBr 600 mg']}, {'name': 'Ertapenem', 'type': 'DRUG', 'description': 'Antibiotic Therapy for cUTI.', 'armGroupLabels': ['Ertapenem 1 g']}, {'name': 'Dummy Infusion', 'type': 'DRUG', 'description': 'Dummy intravenous infusion.', 'armGroupLabels': ['TBPM-PI-HBr 600 mg']}, {'name': 'Dummy tablets', 'type': 'DRUG', 'description': 'Dummy tablets orally.', 'armGroupLabels': ['Ertapenem 1 g']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Medical Facility', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 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