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 @ 1:20 AM
Ignite Modification Date: 2025-12-25 @ 11:28 PM
NCT ID: NCT04154293
Description: follows clinicaltrials.gov definitions. Analysis of adverse events, serious adverse events and other adverse events only on subjects who received at least one dose of study medication; one subject in TMB-001 0.1% arm was randomized but never received study medication due to COVID
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT04154293
Study Brief: A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
TMB-001 Ointment, 0.05% Topical, BID ( twice daily) Isotretinoin: Topical Isotretinoin ointment 0 None 0 11 9 11 View
TMB-001 Ointment, 0.1% Topical, BID (Twice daily) Isotretinoin: Topical Isotretinoin ointment 0 None 0 10 8 10 View
Vehicle Ointment (Control) Topical, BID (Twice daily) Vehicle: Topical Vehicle Ointment 0 None 0 12 3 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
palipations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (10.0) View
ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (10.0) View
application site dermatitis SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site hypersensitivity SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site edema SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site pruritis SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
application site folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
application site pustules SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (10.0) View
epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (10.0) View
night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (10.0) View
application site erosion SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View
application site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA (10.0) View