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 @ 2:31 AM
Ignite Modification Date: 2025-12-26 @ 1:07 AM
NCT ID: NCT03775434
Description: All AEs and SAEs will be collected from Baseline until the final visit or Early Termination Visit. All SAEs will be recorded and reported to the Sponsor or designee within 24 hours. The Investigator or designee will submit any updated SAE data to the Sponsor within 24 hours of it being available.
Frequency Threshold: 0
Time Frame: Baseline to Day 28
Study: NCT03775434
Study Brief: A Study of B244 Delivered as a Topical Spray to Assess Safety in Pediatric Subjects 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
B244 B244 suspension in 30ml/bottle. B244: B244 suspension (4x10E9 cells/ml) in 30ml/bottle 0 None 0 28 11 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Localized infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin burning sensation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View