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 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:07 AM
NCT ID: NCT03824405
Description: Summary of Subjects Excluded From Analyses (Randomized Subjects) BTX 1204 4% BID (N=100) Vehicle BID (N=100) Number of Subjects Excluded from the Safety Population, n (%) BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0) Reason for Exclusion from the Safety Population, n (%) No Post-Baseline Safety Assessment BTX 1204 4% BID 1 (1.0) Vehicle BID 2 (2.0)
Frequency Threshold: 2
Time Frame: 85 days
Study: NCT03824405
Study Brief: Study of the Safety, Tolerability and Efficacy of BTX 1204 in Patients With Moderate 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
BTX 1204 BTX 1204 twice daily BTX 1204: BTX 1204 liquid formulation 0 None 2 99 37 99 View
Vehicle Vehicle twice daily Vehicle: Vehicle liquid formulation 0 None 0 98 25 98 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (22.0) View
Post-procedural complication SYSTEMATIC_ASSESSMENT General disorders MedDRA (22.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Application Site Reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Application Site Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View
Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (22.0) View