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 @ 11:13 PM
Ignite Modification Date: 2025-12-25 @ 8:48 PM
NCT ID: NCT00878969
Description: None
Frequency Threshold: 5
Time Frame: 18 months
Study: NCT00878969
Study Brief: Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months None None 9 26 15 26 View
Ramipril 2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months None None 9 27 15 27 View
Valsartan 80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months None None 8 25 19 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
electroyte disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypertension/hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
musculoskeletal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
generalized symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
access related NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
trauma NON_SYSTEMATIC_ASSESSMENT General disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
blood clot NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
suicide ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
excessive bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
excessive fluid in abdomen NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
access related NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
GI upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
neurological NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hypertension/hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
electrolyte disorder NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
pulmonary NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
musculoskeletal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
generalized symptoms NON_SYSTEMATIC_ASSESSMENT General disorders None View
trauma NON_SYSTEMATIC_ASSESSMENT General disorders None View