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: 2025-12-24 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT01967069
Description: Three subjects in the betamethasone dipropionate spray 0.05% group and two subjects in the vehicle spray group had no post-baseline safety evaluations.
Frequency Threshold: 5
Time Frame: None
Study: NCT01967069
Study Brief: A Comparison of DFD01 Spray Versus Vehicle Spray in Subjects With Moderate Psoriasis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DFD01 Spray DFD01 Spray twice daily DFD01 Spray None None 1 179 17 179 View
Vehicle Spray Vehicle Spray twice daily Vehicle Spray None None 2 93 24 93 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Upper Gastrointestinal Bleed None Gastrointestinal disorders None View
Infection Right Foot None Infections and infestations None View
Exacerbation of Schizophrenia None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application Site Pain None General disorders None View
Application Site Pruritus None General disorders None View