Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:35 PM
NCT ID: NCT04984993
Description: Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
Frequency Threshold: 2
Time Frame: 29 Weeks
Study: NCT04984993
Study Brief: Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
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 Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets 0 None 1 94 16 47 View
MED3000 MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation 0 None 0 94 10 47 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea (Male) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Non-cardiac chest pain (Male) SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.1) View
Back Pain (Male) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.1) View
Headache (Male) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.1) View
Headache (Female) SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (24.1) View
Abdominal distension (Male) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Gamma-glutamyltransferase increased (Male) SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.1) View
Pain in extremity (Male) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (24.1) View