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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT04475432
Description: Corresponds to the standard definition.
Frequency Threshold: 1
Time Frame: 57 days
Study: NCT04475432
Study Brief: Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day for approximately 43 days 0 None 3 212 37 212 View
Control Vehicle of TP-03 topical ophthalmic solution, administered twice a day for approximately 43 days 0 None 1 209 39 209 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 23.0 View
Vascular access site pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Swelling of eyelid NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Visual acuity reduced NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye discharge NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Chalazion NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Eye pruritus NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 23.0 View
Instillation site pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Instillation site pruritus NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View