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 @ 2:39 PM
Ignite Modification Date: 2025-12-25 @ 1:10 PM
NCT ID: NCT00729859
Description: None
Frequency Threshold: 5
Time Frame: Dec 2008 - May 2010
Study: NCT00729859
Study Brief: CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in 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
Group 1: Acyline + Placebo Gel, Placebo Pill Acyline 300 µg/kg injections Day 0 \& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days None None 0 8 6 8 View
Group 2: Acyline, Testosterone Gel, Placebo Pill Acyline 300 µg/kg injections Day 0 \& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days None None 0 6 1 6 View
Group 3: Acyline, Testosterone Gel, Anastrazole Pill Acyline 300 μg/kg injections Day 0 \& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days None None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hot flashes SYSTEMATIC_ASSESSMENT Endocrine disorders None View
emotional lability, irritability SYSTEMATIC_ASSESSMENT Endocrine disorders None View
low libido SYSTEMATIC_ASSESSMENT Endocrine disorders None View
fatigue SYSTEMATIC_ASSESSMENT Endocrine disorders None View
itching at acyline site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
lightheadedness, clammy SYSTEMATIC_ASSESSMENT Endocrine disorders None View
skin irritation, gel application site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
itching rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View