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 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
NCT ID:
NCT00535405
Description:
AE reporting is based on number of subjects at risk. Subjects at risk are randomized subjects who received at least one dose of study drug. Five patients where excluded from the randomized population because they did not receive one dose of study drug (EZ/Simva 20 mg - 3 patients; Atorva 20 mg - 1 patient; Atorva 40 mg - 1 patient).
Frequency Threshold:
1
Time Frame:
None
Study:
NCT00535405
Study Brief:
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
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 10 mg | Atorvastatin (Atorva) 10 mg once daily for 12 weeks | None | None | 4 | 257 | 26 | 257 | View |
| Ezetimibe 10 mg/Simvastatin 20 mg | Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks | None | None | 8 | 256 | 32 | 256 | View |
| Atorvastatin 20 mg | Atorvastatin 20 mg once daily for 12 weeks | None | None | 3 | 258 | 26 | 258 | View |
| Ezetimibe 10 mg/Simvastatin 40 mg | Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks | None | None | 3 | 257 | 32 | 257 | View |
| Atorvastatin 40 mg | Atorvastatin 40 mg once daily for 12 weeks | None | None | 5 | 256 | 30 | 256 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| AV dissociation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal strangulated hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Colitis ischaemic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diverticulum intestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Mechanical complication of implant | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Meniscus lesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Soft tissue injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Melanocytic naevus | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Sarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Panic attack | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Pickwickian syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |