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 @ 9:47 PM
Ignite Modification Date: 2025-12-25 @ 7:26 PM
NCT ID: NCT05295732
Description: TEAEs. An AE is defined as treatment emergent if the AE start on or after treatment start until 30 days after treatment end date.
Frequency Threshold: 5
Time Frame: 24 weeks for the phase 3 trial part and 12 weeks for the Maximal use arm
Study: NCT05295732
Study Brief: The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI 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
Double-blinded Phase: TMB-001 0.05% Double-blinded phase: TMB-001 0.05% (N=78) 0 None 1 78 47 78 View
Double-blinded Phase: Vehicle Double-blinded phase: Vehicle (N=38) 0 None 0 38 17 38 View
Open-label Phase: TMB-001 0.05% QD Open-label phase: TMB-001 0.05% QD (N=28) 0 None 0 28 11 28 View
Open-label Phase: TMB-001 0.05% BID Open-label phase: TMB-001 0.05% BID (N=38) 0 None 0 38 14 38 View
Maximal Use Maximal use (N=34) 0 None 0 34 22 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Viral rash NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Application site erythema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 25.0 View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View
Application site dermatitis NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Application site erosion NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Application site oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Application site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Application site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Folliculitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 25.0 View