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 @ 1:33 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT04658095
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04658095
Study Brief: Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OMNI-canaloplasty Alone The safety analysis population will contain all subjects for whom the OMNI (canaloplasty alone) is attempted 0 None 0 5 3 5 View
OMNI-canaloplasty + Trabeculotomy The safety analysis population will contain all subjects for whom the OMNI (canaloplasty+trabeculotomy) is attempted 0 None 0 1 1 1 View
iStent Inject The safety analysis population will contain all subjects for whom the iStent injectis attempted 0 None 0 4 0 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
IOP elevation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Anterior chamber inflammation NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Allergic conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Tendinitis NON_SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 infection NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View