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: 2025-12-25 @ 2:36 AM
Ignite Modification Date: 2025-12-26 @ 1:14 AM
NCT ID: NCT02461134
Description: All AEs were coded using MedDRA version 19.0. No AEs were reported during the screening period.
Frequency Threshold: 0
Time Frame: Study treatment was terminated on Day 81 and the subject was exposed to ponesimod for a total of 81 days (i.e., Day 1 to Day 81). None of the reported adverse events (AEs) were considered by the investigator to be related to the study drug. As there was only 1 patient enrolled in the study, all (S)AEs reported occur with 100% frequency.
Study: NCT02461134
Study Brief: Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ponesimod It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg). 0 None 1 1 1 1 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Haematemesis, Parainfluenza SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View