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 @ 12:01 AM
Ignite Modification Date: 2025-12-25 @ 9:59 PM
NCT ID: NCT05815758
Description: None
Frequency Threshold: 1
Time Frame: Assessed throughout the study approximately 6-10 weeks
Study: NCT05815758
Study Brief: Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo): Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo) 0 None 0 340 32 340 View
Vehicle Ophthalmic Solution Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution: Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution 0 None 1 170 9 170 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Cholecystitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival Hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
General disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Instillation site irritation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye disorders NON_SYSTEMATIC_ASSESSMENT Eye disorders None View