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 @ 7:24 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT01767103
Description: Safety data were collected from the time of dosing up to the follow-up visit 48 hours post-dose
Frequency Threshold: 0
Time Frame: 2 days
Study: NCT01767103
Study Brief: An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy 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
Mild Hepatic Failure Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points None None 0 7 1 7 View
Moderate Hepatic Failure Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points None None 1 7 3 7 View
Normal Hepatic Function (Healthy Volunteers) Healthy volunteers with normal hepatic function None None 0 7 0 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (15.1) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (15.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (15.1) View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (15.1) View
Gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (15.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (15.1) View