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 @ 1:04 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT01721161
Description: None
Frequency Threshold: 5
Time Frame: AEs were monitored from administration of first dose of study treatment through to Week 32 visit. SAEs were monitored from signing of the Informed Consent Form (ICF) through to Week 32 visit.
Study: NCT01721161
Study Brief: BIIB033 In Acute Optic Neuritis (AON)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) None None 2 41 25 41 View
BIIB033 100 mg/kg BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses) None None 5 41 27 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 17.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 17.0 View
Viral pericarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Cytomegalovirus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Multiple sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Optic neuritis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Colour blindness acquired SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 17.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.0 View
Dysaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Multiple sclerosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Uhthoff's phenomenon SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View
Visual field defect SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View