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 @ 10:47 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT00732069
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT00732069
Study Brief: Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ramipril All subjects receiving ramipril None None 0 15 1 15 View
Valsartan All subjects receiving valsartan None None 0 15 4 15 View
Placebo All subjects receiving placebo None None 1 16 7 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cerebrovascular ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bruising after falling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pain not cardiac SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vascular acces complication SYSTEMATIC_ASSESSMENT Vascular disorders None View