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: 2025-12-26 @ 11:12 PM
Ignite Modification Date: 2025-12-26 @ 11:12 PM
NCT ID: NCT01465412
Description: All participants who received an oral dose of preladenant.
Frequency Threshold: 5
Time Frame: Up to 7 days
Study: NCT01465412
Study Brief: A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
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 Impaired (HI) Part 1 Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1. None None 0 12 2 12 View
Healthy to Match Mild HI Part 1 Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1. None None 0 12 0 12 View
Moderate HI Part 2 Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1. None None 0 9 1 9 View
Healthy to Match Moderate HI Part 2 Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1. None None 0 9 1 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View