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: 2025-12-26 @ 11:12 PM
Ignite Modification Date: 2025-12-26 @ 11:12 PM
NCT ID: NCT00504712
Description: Specific Adverse Event terms were not used for this study.
Frequency Threshold: 0
Time Frame: None
Study: NCT00504712
Study Brief: Testosterone for Peripheral Vascular Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Testosterone 200 mg intramuscular every 2 weeks Testosterone: Sustanon- 200mg- Intramuscular testosterone every 2 weeks None None 1 11 3 11 View
Placebo Saline saline: Saline injection every two weeks None None 2 13 4 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious None General disorders None View
Adverse Event None Renal and urinary disorders None View
Serious None Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Adverse Event None General disorders None View
Adverse None Respiratory, thoracic and mediastinal disorders None View
Adverse None Skin and subcutaneous tissue disorders None View
Adverse None General disorders None View
Adverse None General disorders None View
adverse None Infections and infestations None View
Adverse None General disorders None View