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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT03150160
Description: The Safety analysis set included all patients exposed to at least one dose of any study therapy. Note: Number at risk for Simbrinza + Travatan is reported as 0 because no patients were exposed to this study therapy.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately six weeks.
Study: NCT03150160
Study Brief: Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Simbrinza + Travatan Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening) 0 None 0 0 0 0 View
Placebo + Travatan Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening) 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
common cold SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v. 20 View