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 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT03647033
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT03647033
Study Brief: Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Phacoemulsification Alone routine phacoemulsification cataract surgery with intraocular lens implantation 0 None 0 16 2 16 View
Phacoemulsification and iStent phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation iStent implantation: The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted. 0 None 0 16 10 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
intraoperative hyphema NON_SYSTEMATIC_ASSESSMENT Eye disorders hyphema View
intraoperative iris prolapse NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
intraoperative iris trauma NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
intraoperative iridodialysis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View