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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT00112151
Description: Systematic assessments were done at baseline, 4, 12, 26 and 52 weeks. As prespecified, adverse events were analyzed according to T dosing (e.g. placebo, lower-range T, and higher-range T).
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT00112151
Study Brief: TEAM: Testosterone Supplementation and Exercise in Elderly Men
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 Placebo gel with or without progressive resistance training None None 30 47 23 47 View
Lower-range T T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training None None 33 47 14 47 View
Higher-range T T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training None None 38 49 25 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Total serious cardiovascular adverse events NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other noncardiovascular serious adverse events NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated AUA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other nonserious adverse events NON_SYSTEMATIC_ASSESSMENT General disorders None View
Persistently elevated HCT >= 54% SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Persistently elevated PSA SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Persistently elevated liver function tests SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Daytime somnolence/hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View