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: 2025-12-25 @ 1:07 AM
Ignite Modification Date: 2025-12-25 @ 11:19 PM
NCT ID: NCT01989793
Description: None
Frequency Threshold: 4
Time Frame: 24 weeks
Study: NCT01989793
Study Brief: A Study of Muscle Strength Maintenance in Older Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Losartan For those subjects randomized to the losartan group, they will receive losartan 25mg by mouth daily for 8 weeks, then increase to 50mg by mouth daily for another 8 weeks, then increase to 100mg by mouth daily for a final 8 weeks. Losartan: Losartan will be given in increasing doses to those in the losartan arm. 1 None 1 18 4 18 View
Placebo For those subjects randomized to placebo, they will receive a placebo to take for 24 weeks total. Placebo: Placebo will be given to those in placebo arm 0 None 0 19 0 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Creatinine NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View