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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT00418834
Description: The number of subjects at risk for reported adverse events is based on an All-Patients-as-Treated population, which includes all randomized patients who received at least one dose of double-blind study therapy
Frequency Threshold: 1
Time Frame: None
Study: NCT00418834
Study Brief: Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Atorva 20 mg / Atorva 40 mg Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks None None 14 None 54 None View
Atorva 10 mg + EZ \[Atorva 10 mg + Ezetimibe 10 mg\] orally once daily for 12 weeks None None 15 None 46 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Appendicitis perforated NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Lower gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis chronic NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Basal cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Brain stem haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness postural NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Intracranial aneurysm NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Toxic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleuritic pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Asparate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood glucose increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Muscle spasm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View