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 @ 12:19 AM
Ignite Modification Date: 2025-12-25 @ 10:22 PM
NCT ID: NCT00639158
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00639158
Study Brief: Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe None None None 3 272 41 272 View
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe None None None 5 270 51 270 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain Upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Bladder Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Breast Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Esophageal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Non-Cardiac Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Subcutaneous Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Wound Infection Staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Muscle Spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View