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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:56 PM
NCT ID: NCT04032158
Description: SAF analysis set included all participants who were administered any dose of any study intervention.
Frequency Threshold: 0
Time Frame: Baseline up to 235 days
Study: NCT04032158
Study Brief: Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Evobrutinib + Avonex® Matched Placebo Participants received active evobrutinib twice daily (BID) along with concomitant intramuscular (IM) injection of placebo matched to Avonex® once a week. Treatment period was planned to be of 96 weeks. 0 None 0 2 2 2 View
Active Comparator: Avonex® + Evobrutinib Matched Placebo Participants received IM injection of active Avonex® once a week along with concomitant placebo matched to evobrutinib BID. Treatment period was planned to be of 96 weeks. 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Tension headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Drug eruption NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Influenza like illness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Pain in jaw NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 23.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Tinea cruris NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 23.0 View