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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01097668
Description: Adverse Events were recorded in the Case Report Form and characterised by severity, relationship to IMP,outcome, action taken, onset and resolution date and seriousness. Occurrences of Multiple Sclerosis relapses were recorded as Adverse Events.
Frequency Threshold: 0
Time Frame: Adverse event data collected over the course of the study = 52 weeks
Study: NCT01097668
Study Brief: ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intradermal Injection - Treatment Emergent Injections will be administered by the intradermal route None None 1 21 17 21 View
Subcutaneous Injection - Treatment Emergent Injections will be administered by the subcutaneous route None None 0 22 16 22 View
Intradermal Injection - Non Treatment Emergent Follow-up period None None 2 21 7 21 View
Subcutaneous Injection - Non Treatment Emergent Follow-up period None None 1 22 5 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple Sclerosis Relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Reactions SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.0 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Anti-peptide Antibody response SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View