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: 2025-12-24 @ 11:30 PM
Ignite Modification Date: 2025-12-25 @ 9:18 PM
NCT ID: NCT01405456
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT01405456
Study Brief: Eplerenone in HIV Associated Abdominal Fat Accumulation
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 and Lifestyle First 6 months: eplerenone 50mg daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: same (eplerenone open label during second 6 months) Eplerenone and lifestyle: eplerenone 50mg by mouth daily as well as lifestyle counseling 0 None 0 25 13 25 View
Placebo and Lifestyle First 6 months: placebo pill daily along with lifestyle modification (counseling regarding lifestyle and diet, as well as following healthy activity guidelines) Second 6 months: eplerenone (open label) 50mg daily along with continued lifestyle modification placebo and lifestyle: placebo pill daily and lifestyle counseling 0 None 0 21 11 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Symptoms NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Musculoskeletal Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mood Symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Creatinine NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View