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 @ 3:54 PM
Ignite Modification Date: 2025-12-25 @ 1:59 PM
NCT ID: NCT05696392
Description: Adverse events have been reported for the Safety Population, comprised of all participants who received at least 1 application of study drug during the treatment period.
Frequency Threshold: 0
Time Frame: up to 12 weeks
Study: NCT05696392
Study Brief: The Purpose of This Study is to Evaluate the Effects of Ruxolitinib Cream on Adults With Atopic Dermatitis Experiencing Sleep Disturbance.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for up to 8 weeks to a total maximum allowed treatment area of ≤20% body surface area. 0 None 0 47 7 47 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View