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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT06091956
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the first administration of study treatment through 30 days following the last administration of study treatment, approximately 28 weeks.
Study: NCT06091956
Study Brief: A Study of Deucravacitinib to Treat LPP and FFA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Deucravacitinib Treatment for Lichen Planopilaris Subjects diagnosed with Lichen Planopilaris (LP) received Deucravacitinib for 24 weeks. Deucravacitinib: 6 milligram (mg) orally administrated, twice daily 0 None 1 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colon and Rectal Surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash on Neck SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore Throat/Lymph Nodes SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hair Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Mouth Sore SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hand Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash/Acne SYSTEMATIC_ASSESSMENT Infections and infestations None View
Virus (cold/flu) SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bakers Cyst SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Canker Sore and Mouth Tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Canker Sores on Tongue SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal Pain after starting Protopic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inflammation of Gingiva SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Burning SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mouth Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in Right Ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View