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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:48 AM
NCT ID: NCT01253902
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01253902
Study Brief: Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Latanoprost Ophthalmic Solution 0.005% One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks. None None 3 55 0 55 View
Bimatoprost Ophthalmic Solution 0.01% One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks. None None 1 56 0 56 View
Travoprost Ophthalmic Solution 0.004% One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks. None None 1 53 0 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection from Punctured colon SYSTEMATIC_ASSESSMENT Infections and infestations None View
Branch retinal artery occlusion SYSTEMATIC_ASSESSMENT Eye disorders None View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Vascular disorders None View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gastrointestinal Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Punctured colon SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Aspiration Pneumonia resulting in death SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):