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 @ 3:59 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT00626392
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00626392
Study Brief: Study to Evaluate the EFFECTS of Acetylsalicylic Acid (ASA) on Niaspan®-Induced Flushing in Subjects With Dyslipidemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Any Acetylsalicylic Acid Pooled arms that received acetylsalicylic acid (ASA) 325 mg during run-in and/or coadministration. None None 1 None 119 None View
No Acetylsalicylic Acid Pooled arms that received acetylsalicylic acid placebo (ASA Pbo) during run-in and coadministration. None None 1 None 72 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Esophageal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10-1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View