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 @ 9:59 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT02994732
Description: Adverse event definitions; assignment of severity, causality, action taken, and outcome; and procedures for reporting serious AEs (SAEs) are detailed in Appendix C of the protocol. None of the definitions differ from the clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: 27 days
Study: NCT02994732
Study Brief: Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled BVD-523 in Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Study Six subjects were enrolled in, dosed, and completed study. All six subjects were male, 4 subjects were white and 2 subjects were black or African American. 0 None 0 6 2 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View