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 @ 12:08 PM
Ignite Modification Date: 2025-12-25 @ 11:59 AM
NCT ID: NCT05764161
Description: For participants who were on vehicle up to Week 12 and then switched to ruxolitinib, adverse events are presented by the treatment they were on at the onset of the event. Data have been presented for the Safety Population, comprised of all participants who applied at least one dose of ruxolitinib 1.5% cream or vehicle cream.
Frequency Threshold: 5
Time Frame: up to Week 56
Study: NCT05764161
Study Brief: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
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 BID to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion for 12 weeks in the DBVC Period and for 40 weeks in the OLE Period. Participants who applied matching vehicle cream BID for 12 weeks during the DBVC Period and completed the Week 12 assessments with no safety concerns applied ruxolitinib 1.5% cream for 40 weeks during the OLE Period. 0 None 4 178 19 178 View
Vehicle Cream BID Participants applied vehicle cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. 0 None 0 94 4 94 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View