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 @ 11:56 PM
Ignite Modification Date: 2025-12-25 @ 9:53 PM
NCT ID: NCT00842751
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00842751
Study Brief: Oral T7 Oral Testosterone in Man
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
First Intervention Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally None None 0 11 4 11 View
Second Intervention Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally None None 0 11 2 11 View
Third Intervention Acyline 300mcg/kg subcutaneous on days 1, 15 \& 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally None None 0 11 3 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hot flashes SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Testicular Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Upset Stomach & Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View