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 @ 11:04 PM
Ignite Modification Date: 2025-12-25 @ 8:35 PM
NCT ID: NCT00345969
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT00345969
Study Brief: Exercise and Testosterone Therapy in Elderly Men With Physical Frailty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exercise + Placebo Participants assigned to this group were prescribed an inactive topical gel for 6 months, and also performed a supervised exercise training program three times per week for 6 months. None None 0 12 1 12 View
Exercise + Testosterone Participants assigned to this group were prescribed transdermal testosterone (Androgel 1%) for six months, and performed a supervised exercise training program three times per week for six months. None None 1 13 1 13 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
Elevated serum PSA level SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View