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 @ 3:50 AM
NCT ID: NCT05355818
Description: None
Frequency Threshold: 5
Time Frame: Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.
Study: NCT05355818
Study Brief: Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Delgocitinib Cream Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Delgocitinib cream: Cream for topical application. 0 None 0 74 17 74 View
Cream Vehicle Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety. Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient. 0 None 0 24 4 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View