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 @ 3:52 AM
Ignite Modification Date: 2025-12-26 @ 2:41 AM
NCT ID: NCT00129402
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00129402
Study Brief: Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ezetimibe With Simvastatin Column 1 provides the combined AE data collected for subjects in the ezetimibe with simvastatin treatment groups during Period 1 and Period 2 None None 4 126 58 126 View
Simvastatin Monotherapy Column 2 provides the combined AE data collected for subjects in the simvastatin monotherapy treatment groups during Period 1 and Period 2. None None 1 122 59 122 View
Long-term Coadministration of Ezetimibe With Simvastatin Column 3 provides the combined AE data collected for all subjects that participated during Period 3. One subject who entered Period 3 did not receive study medication and was not included in the analysis. None None 3 227 42 227 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Pilonidal cyst SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.0 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.0 View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 9.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 9.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 9.0 View