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 @ 2:09 AM
Ignite Modification Date: 2025-12-26 @ 12:36 AM
NCT ID: NCT04487860
Description: The Safety Population will consist of all subjects who were randomized into the study and dispensed study drug. This population will be the primary population for the safety analysis. Subjects will be analyzed according to the actual treatment received
Frequency Threshold: 5
Time Frame: 64 Week
Study: NCT04487860
Study Brief: Efficacy and Safety of AS012 in Subjects With Non-segmental Vitiligo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AS012 Dose Regimen III - Part II AS012 dose 4 x - Part II 0 None 0 46 0 46 View
AS012 Dose Regimen IV - Part II AS012 dose 6 x - Part II 0 None 0 54 0 54 View
AS012 - Part III treatment free 0 None 0 162 0 162 View
AS012 Dose Regimen II - Part II AS012 dose 2 x - Part II 0 None 0 59 0 59 View
AS012 Dose Regimen IV - Part I AS012 dose 6x- Part I 0 None 0 72 0 72 View
Placebo - Part I Placebo - Part I 0 None 0 59 0 59 View
AS012 Dose Regimen I- Part I AS012 dose x- Part I 0 None 0 62 0 62 View
AS012 Dose Regimen II - Part I AS012 dose 2x- Part I 0 None 0 70 0 70 View
AS012 Dose Regimen III - Part I AS012 dose 4x- Part I 0 None 0 63 0 63 View
Placebo to AS012 Dose Regimen II at Week 24 - Part II Placebo to AS012 dose 2x at Week 24 - Part II 0 None 0 20 1 20 View
Placebo to AS012 Dose Regimen IV at Week 24 - Part II Placebo to AS012 dose 6x at Week 24 - Part II 0 None 0 20 0 20 View
AS012 Dose - Regimen I - Part II AS012 dose X- Part II 0 None 0 44 0 44 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View