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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT03127956
Description: The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Frequency Threshold: 2
Time Frame: Baseline to Week 36
Study: NCT03127956
Study Brief: A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face 0 None 8 741 281 741 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site dryness SYSTEMATIC_ASSESSMENT General disorders None View
Application site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Application site pain SYSTEMATIC_ASSESSMENT General disorders None View
Application site pruritus SYSTEMATIC_ASSESSMENT General disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sunburn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View