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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT01032993
Description: 3 serious adverse events occurred during the study that were judged unrelated to the study agent. Specifically, 3 participants were hospitalized prior to randomization: 1 for pneumonia; 1 for a back injury; and 1 for a mental health condition. All recovered. There were no SAE during the randomization period. Non serious AEs are listed below.
Frequency Threshold: 0
Time Frame: Serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.
Study: NCT01032993
Study Brief: Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Coenzyme Q10 CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily None None 0 19 4 19 View
Placebo Placebo 2 x daily + Simvastatin 20 mg daily None None 0 20 2 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea/dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View