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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT02805257
Description: In our study protocol, we defined Serious Adverse Events as the following "A SAE is any adverse event that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, or a persistent or significant disability/incapacity."
Frequency Threshold: 0
Time Frame: Over 1 Year
Study: NCT02805257
Study Brief: Ahmed Glaucoma Valve Surgery With Mitomycin-C
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mitomycin-C 0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. Mitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol 0 None 0 53 23 53 View
Balanced Salt Solution (BSS) 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Balanced Salt Solution: Intraoperative and postoperative injections of BSS 1 None 0 52 21 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tube Occlusion SYSTEMATIC_ASSESSMENT Eye disorders None View
Choroidal Effusion SYSTEMATIC_ASSESSMENT Eye disorders None View
Suprachoroidal hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyphema SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Shallow Anterior Chamber SYSTEMATIC_ASSESSMENT Eye disorders None View
Corneal edema SYSTEMATIC_ASSESSMENT Eye disorders None View
Other SYSTEMATIC_ASSESSMENT Eye disorders None View