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: 2025-12-25 @ 4:49 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT01037218
Description: None
Frequency Threshold: 2
Time Frame: Twelve weeks
Study: NCT01037218
Study Brief: Treatment of Erectile Dysfunction II
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Udenafil 50 mg Udenafil 50 mg tablets None None 1 147 43 147 View
Udenafil 100 mg Udenafil 100 mg tablets None None 1 148 51 148 View
Udenafil 150mg Udenafil 150mg tablets None None 3 154 49 150 View
Placebo Placebo tablets None None 1 150 11 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary Artery Stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.1) View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.1) View
Small Intestinal Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.1) View
Angina Unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (12.1) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.1) View
Lung Squamous Cell Carcinoma Stage Unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (12.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.1) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.1) View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (12.1) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (12.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (12.1) View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.1) View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (12.1) View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (12.1) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (12.1) View
Blood Creatine Phosphokinase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (12.1) View