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 @ 10:00 PM
Ignite Modification Date: 2025-12-25 @ 7:37 PM
NCT ID: NCT05593432
Description: For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
Frequency Threshold: 5
Time Frame: from Baseline to Week 32 plus 30 days
Study: NCT05593432
Study Brief: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vehicle Cream BID Participants applied matching vehicle cream BID for 16 weeks in the Double-Blind, Vehicle-Controlled Period. 0 None 0 32 6 32 View
Ruxolitinib Cream 1.5% BID Participants who applied ruxolitinib cream 1.5% BID for 16 weeks during the Double-Blind, Vehicle-Controlled Period plus participants who completed the Week 16 assessments with no safety concerns, continued into the Open-label Extension Period, and applied ruxolitinib cream 1.5% BID for an additional 16 weeks 0 None 0 60 14 60 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.1 View