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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:24 PM
NCT ID: NCT00798759
Description: This reporting group includes all patients who received test article.
Frequency Threshold: 5
Time Frame: Adverse events were collected for the duration of the study: 22 December 2008 to 20 May 2009.
Study: NCT00798759
Study Brief: Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Travoprost One drop self administered in the study eye(s) once daily at night for 12 weeks None None 1 117 7 117 View
Latanoprost One drop self administered in the study eye(s) once daily at night for 12 weeks None None 2 119 3 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood urine present None Investigations MeDRA 11.0 View
Dehydration None Metabolism and nutrition disorders MeDRA 11.0 View
Coronary Arterial Stent Insertion None Surgical and medical procedures MeDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry Eye None Eye disorders MeDRA 11.0 View