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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:03 PM
NCT ID: NCT03359356
Description: None
Frequency Threshold: 0
Time Frame: 48 weeks
Study: NCT03359356
Study Brief: Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching placebo in prefilled syringes identical to the dupilumab syringes. 24 weeks of Placebo 0 None 0 20 4 20 View
Dupilumab Matching placebo in prefilled syringes identical to the dupilumab syringes. After 24 weeks of Placebo, an initial dose of 600 mg Dupilumab (two 300 mg subcutaneous injections), followed by an open-label period in which 300 mg given every other week. A total of 24 Dupilumab doses. 0 None 1 40 22 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bladder Cancer SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Eosinophilic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other orthopedic injuries/procedures SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bladder malignancy SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostatic hyperplasia SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Facial rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjuctivitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations None View