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 @ 6:45 PM
Ignite Modification Date: 2025-12-25 @ 4:16 PM
NCT ID: NCT00705757
Description: None
Frequency Threshold: 1
Time Frame: Data was collected for one year.
Study: NCT00705757
Study Brief: The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lumigan Participants were assigned to use Lumigan/bimatoprost 0.03% ophthalmic solution one drop qhs for one year in affected eye(s) None None 0 32 1 32 View
Travatan Participants were assigned to use Travatan/travoprost 0.004% ophthalmic sol., one drop qhs for one year in affected eye(s) None None 0 28 0 28 View
Xalatan Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s) None None 0 29 0 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Recurrence of iritis at 6 week visit NON_SYSTEMATIC_ASSESSMENT Eye disorders None View