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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT01444651
Description: Adverse events ascertained at each follow-up visit
Frequency Threshold: 0
Time Frame: Adverse events recorded during study duration (3 months)
Study: NCT01444651
Study Brief: A Trial of Tadalafil and Glycemic Traits
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tadalafil 20 mg Tadalafil tablet taken by mouth once a day for 3 months Tadalafil: 20 mg Tadalafil taken once a day for 3 months None None 0 36 7 36 View
Placebo Placebo tablet taken by mouth once a day for 3 months Placebo: Placebo tablet taken by mouth once a day for 3 months None None 0 37 2 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Vascular disorders None View
Blurry vision and headache SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache and back ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
arm pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back or leg pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View