Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 8:02 PM
Ignite Modification Date: 2025-12-25 @ 5:35 PM
NCT ID: NCT02342704
Description: Treatment-emergent adverse events are presented.
Frequency Threshold: 5
Time Frame: Up to 64 weeks.
Study: NCT02342704
Study Brief: Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Natalizumab Open-label natalizumab 300 mg IV every 4 weeks None None 0 54 14 54 View
Fingolimod Open-label fingolimod 0.5 mg once daily orally None None 2 54 23 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrioventricular block second degree SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Migraine with aura SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View