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 @ 2:07 AM
Ignite Modification Date: 2025-12-26 @ 12:33 AM
NCT ID: NCT00673660
Description: The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00673660
Study Brief: Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Statins at Visit 2 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). None None 0 153 5 153 View
Statins at Visit 3 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). None None 0 76 4 76 View
Statins at Visit 4 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). None None 0 44 4 44 View
Statins Visit 5 Participants with dyslipidemia who were taking or were planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin, or generics). None None 0 268 6 268 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Myalgia SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Nausea SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Elevated liver enzyme levels SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Visual impairment SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Other SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Allergic reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Arthralgia SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Dizziness SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Constipation SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Gas SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Pharyngitis SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Rash on hands SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Cough SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Renal failure SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View
Vertigo SYSTEMATIC_ASSESSMENT General disorders MedDRA v11.1 View