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 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT00770133
Description: None
Frequency Threshold: 5
Time Frame: 14 days
Study: NCT00770133
Study Brief: Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketotifen/Naphazoline Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4. None None 0 35 0 35 View
Vehicle Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4. None None 0 35 0 35 View
Ketotifen Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4. None None 0 36 0 36 View
Naphazoline Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4. None None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):