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 @ 9:14 PM
Ignite Modification Date: 2025-12-25 @ 7:03 PM
NCT ID: NCT02125604
Description: None
Frequency Threshold: 5
Time Frame: Serious adverse events: from signing of informed consent through last dose (up to 12 weeks (±5 days) plus 2 weeks (±5 days) follow up. Adverse events: from time of first dose of dimethyl fumarate through last dose (up to 12 weeks (±5 days).
Study: NCT02125604
Study Brief: Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dimethyl Fumarate Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks. None None 5 211 129 211 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 19.0 View
Alanine aminotransferase increrased SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Gamma-glutamyltransferase SYSTEMATIC_ASSESSMENT Investigations MedDRA 19.0 View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 19.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 19.0 View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.0 View