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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:39 PM
NCT ID: NCT01243567
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01243567
Study Brief: Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months. None None 1 43 9 43 View
Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months. None None 0 38 10 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ocular Hyperaemia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 12.1 View
Blepharitis NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 12.1 View
Conjunctival Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 12.1 View
Foreign Body Sensation in Eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA version 12.1 View