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 @ 4:35 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT01220466
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01220466
Study Brief: Performance and Acceptability of iDesign
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hyperopia With and Without Astigmatism Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D None None 1 11 2 11 View
Myopia With and Without Astigmatism Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D. None None 2 56 4 56 View
Mixed Astigmatism Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs. None None 0 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Decrease in BSCVA of greater than or equal to two lines SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Foreign body in the eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Miscreated flap SYSTEMATIC_ASSESSMENT Eye disorders None View
retinal tear/hole SYSTEMATIC_ASSESSMENT Eye disorders None View
Other - car accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other - concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Corneal epithelial defect NON_SYSTEMATIC_ASSESSMENT Eye disorders None View