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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT05028634
Description: As pre-specified per protocol, Cohort 1 and Cohort 2 are pooled per the following treatment groups. i. Ozanimod treatment group ii. Non-Ozanimod treatment group Modified Intent-to-Treat (mITT) Population consists of all participants who received at least one vaccination and summarized according to their initial treatment status (ozanimod vs. non-ozanimod) regardless of systemic use of corticosteroids.
Frequency Threshold: 5
Time Frame: All cause mortality and Non Serious and Serious adverse events were collected from first dose (Day 1) until end of study visit (Day 28).
Study: NCT05028634
Study Brief: Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ozanimod Participants with relapsing forms of Multiple Sclerosis (MS) who received Oral Ozanimod were administered with regimen of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis, Adsorbed (Tdap) vaccine, Pneumococcal polysaccharide (PPSV23), and the seasonal inactivated influenza vaccine on Day 1. 0 None 0 30 5 30 View
Non-Ozanimod Participants with relapsing forms of Multiple Sclerosis (MS) who have received either non-pegylated interferon-β (IFN-β) or no disease modifying therapy (DMT) and already received the seasonal inactivated influenza vaccine receive regimen of Tdap and PPSV23 vaccine only on Day 1. 0 None 0 33 7 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.1 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View