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 @ 1:06 AM
NCT ID: NCT04753034
Description: None
Frequency Threshold: 0
Time Frame: 29 days
Study: NCT04753034
Study Brief: Study of TER-101 Topical Ointment in 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
TER-101 BID (twice daily) application TER-101: Active Comparator 0 None 1 31 9 31 View
Vehicle Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator 0 None 0 32 3 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Kidney infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dermatitis atopic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View
Seborrhoeic dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View
Skin hypopigmentation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View
Urticaria NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 24.0 View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Product intolerance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Application site inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Hangover NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA version 24.0 View
Pilonidal cyst NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 24.0 View
Bundle branch block right NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 24.0 View
Eye irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 24.0 View
Sinus congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 24.0 View