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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT02019550
Description: None
Frequency Threshold: 0
Time Frame: Baseline up to Week 8
Study: NCT02019550
Study Brief: Rebif® Rebidose® Versus Rebiject II® Ease-of-Use
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rebiject II Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2. None None 0 97 5 97 View
Rebif Rebidose Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2. None None 1 95 3 95 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Staphylococcal osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bruising at injection site-Left thigh NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Dosing error NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Numbness of right hand NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Redness NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Worsening of bunion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Post bunionectomy pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Allergic reaction to artificial sweetener (aspartame) NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Tendonitis Right ring finger/hand NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Bilateral feet pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Right abdomen wall injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View