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 @ 12:24 AM
Ignite Modification Date: 2025-12-25 @ 10:28 PM
NCT ID: NCT00276458
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00276458
Study Brief: To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atorvastatin + Ezetimibe Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks None None 0 96 17 96 View
Atorvastatin Atorvastatin 40 mg Daily for 6 weeks None None 0 98 22 98 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Abdominal tenderness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal Disorder NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Irritable bowel syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest Discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Blood creatinine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Gamma-glutamyltransferase increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Intervertebral disc disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Seborrhoeic keratosis NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Actinic keratosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View