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 @ 3:52 PM
Ignite Modification Date: 2025-12-25 @ 1:58 PM
NCT ID: NCT03011892
Description: None
Frequency Threshold: 5
Time Frame: Up to Week 24
Study: NCT03011892
Study Brief: A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
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 BID Participants applied vehicle cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks. 0 None 0 52 10 52 View
Triamcinolone 0.1% BID for 4 Weeks Then 4 Week Vehicle BID Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks. At Week 8, participants who met criteria were offered open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks. 0 None 1 51 3 51 View
INCB018424 0.15% QD Participants applied Ruxolitinib 0.15% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks. 0 None 0 51 6 51 View
INCB018424 1.5% BID Participants applied Ruxolitinib 1.5% cream BID for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks. 0 None 0 259 23 259 View
INCB018424 1.5% QD Participants applied Ruxolitinib 1.5% QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks. 0 None 0 51 6 51 View
INCB018424 0.5% QD Participants applied Ruxolitinib 0.5% cream QD for 8 weeks. At Week 8, participants who met criteria were offered open-label treatment with Ruxolitinib 1.5% cream BID for 4 weeks. 0 None 0 51 2 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 19.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 19.1 View