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: 2025-12-24 @ 5:05 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT03896750
Description: None
Frequency Threshold: 5
Time Frame: Participants were assessed for SAEs and all cause mortality from the time of study product administration through Day 85. Adverse events and clinical safety laboratory events were evaluated from the first study product administration through Day 12.
Study: NCT03896750
Study Brief: Single-Dose Study to Evaluate the PKs of Pretomanid in Participants With Renal Impairment Compared to Participants With Normal Renal Function
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Matched Controls Healthy participants with normal renal function received a single oral dose of 200 mg pretomanid 0 None 0 6 0 6 View
ESRD Not on Dialysis Participants with End Stage Renal Disease (ESRD) not on dialysis received a single oral dose of 200 mg pretomanid 0 None 0 1 0 1 View
Severe Renal Impairment Participants with severe renal impairment received a single oral dose of 200 mg pretomanid 0 None 0 5 3 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v27.01 View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v27.01 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v27.01 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v27.01 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v27.01 View