Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:47 PM
NCT ID: NCT03788967
Description: Safety analysis population included all randomized participants who received any amount of study drug.
Frequency Threshold: 5
Time Frame: From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days)
Study: NCT03788967
Study Brief: 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)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TBPM-PI-HBr 600 mg 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. 0 None 14 685 39 685 View
Ertapenem 1 g 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. 0 None 12 687 30 687 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders 23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.0 View
Pulmonary artery thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.0 View
Duodenal ulcer hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders 23.0 View
Cyst SYSTEMATIC_ASSESSMENT General disorders 23.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Perirectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Retroperitoneal abscess SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations 23.0 View
Procedural pneumothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 23.0 View
Clostridium test positive SYSTEMATIC_ASSESSMENT Investigations 23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.0 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 23.0 View
Generalized tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders 23.0 View
Radiculopathy SYSTEMATIC_ASSESSMENT Nervous system disorders 23.0 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders 23.0 View
Acute pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 23.0 View
Subcutaneous emphysema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 23.0 View