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 @ 7:11 PM
Ignite Modification Date: 2025-12-25 @ 4:45 PM
NCT ID: NCT01140503
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01140503
Study Brief: A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Apremilast All subjects received apremilast 20mg PO BID None None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bruising NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Indigestion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Migraine headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Left Knee Injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated serum creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View