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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT02629094
Description: None
Frequency Threshold: 0
Time Frame: 32 weeks
Study: NCT02629094
Study Brief: Cardiometabolic Effects of Eplerenone in HIV Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eplerenone Eplerenone 25mg once/day for one week; 50mg once/day 23 weeks 0 None 0 5 5 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood calcium increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood magnesium decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood phosphorus decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Low density lipoprotein increased SYSTEMATIC_ASSESSMENT Investigations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Tooth disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood bicarbonate decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood sodium decreased SYSTEMATIC_ASSESSMENT Investigations None View