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 @ 12:41 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT02881567
Description: None
Frequency Threshold: 5
Time Frame: First dose of study drug to within 30 days of last dose (up to 11 months)
Study: NCT02881567
Study Brief: Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Daclizumab Participants previously treated with natalizumab for at least 12 months and who discontinued treatment, received daclizumab 150 mg per 1.0 mL administered subcutaneously once a month for up to 11 months. 0 None 9 41 23 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Gastrointestinal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 21.1 View
Encephalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 21.1 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Drug reaction with eosinophilia and systemic symptoms SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 21.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Multiple sclerosis relapse SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 21.1 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 21.1 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 21.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 21.1 View