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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT00790751
Description: \# participants at risk is presented for the safety population. The Safety Population was defined as all subjects who took at least one dose of study drug and had safety data available.
Frequency Threshold: 2
Time Frame: AE reporting began when the subject provided written informed consent and extended until 28 calendar days after the last dose of the investigational product was administered, or until the subject was discontinued from the study, whichever was later.
Study: NCT00790751
Study Brief: Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Avanafil 200 mg avanafil 200 mg 30 minutes orally prior to initiation of sexual activity None None 3 162 31 162 View
Avanafil 100 mg avanafil 100 mg 30 minutes orally prior to initiation of sexual activity None None 3 161 28 161 View
Placebo placebo 30 minutes orally prior to initiation of sexual activity None None 2 161 7 161 View
Avanafil 50 mg avanafil 50 mg 30 minutes orally prior to initiation of sexual activity None None 1 160 16 160 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.1) View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.1) View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.1) View
Prostate cancer stage I SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (11.1) View
Gun shot wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.1) View
Infected bites SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.1) View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (11.1) View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View