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 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT03965351
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected on a per patient basis from the beginning of enrollment at consent to subject completion or withdrawal (whichever came first) up to a maximum of 16 weeks
Study: NCT03965351
Study Brief: TRPV2 Agonists in the Fontan Circulation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Probenecid Participants in this arm were randomly assigned to receive probenecid (study medication) during the first phase, then went through a washout phase, and finally received a placebo during the last phase. 0 None 0 8 1 8 View
Placebo Participants in this arm were randomly assigned to receive placebo during the first phase, then went through a washout phase, and finally received the study medication, probenecid, during the last phase. 0 None 1 8 4 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Contraindicated Medication Taken NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Overdose of study medication NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospital Admission NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rhinovirus NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Migraine NON_SYSTEMATIC_ASSESSMENT General disorders None View
Weight Gain NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Elevated NT-proBNP NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Sore Throat NON_SYSTEMATIC_ASSESSMENT General disorders None View
Loss of appetite NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View