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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:37 AM
NCT ID: NCT03697460
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected from baseline to end of study, approximately 12 weeks.
Study: NCT03697460
Study Brief: Topical Ruxolitinib 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
INCB018424 Subjects applied INCB018424 topically, twice daily. INCB018424 Cream INCB018424: INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP. 0 None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal Taste SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blood Clot SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cold SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Light headedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep Disturbance SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pressure on right arm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Sinus Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vaginal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Yeast Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View