Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:12 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT00367458
Description: None
Frequency Threshold: 0
Time Frame: Date treatment consent signed to date off study, approximately 26 weeks
Study: NCT00367458
Study Brief: Randomized Placebo-Controlled Trial of Atorvastatin in HIV-Positive Patients Not on Antiretroviral Therapy
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 Patients were randomized to receive Atorvastatin for 8 weeks 0 None 2 24 12 24 View
Placebo Patients were randomized to receive placebo for 8 weeks 0 None 2 24 0 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
low LDL SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abscess SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Herpes simplex SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hot flush SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Supplementation therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Treponema test positive SYSTEMATIC_ASSESSMENT Infections and infestations None View