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 @ 1:06 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT04805593
Description: AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes.
Frequency Threshold: 5
Time Frame: Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 1 year.
Study: NCT04805593
Study Brief: Clinical Investigation of the WaveLight® EX500 Excimer Laser
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pretreament AEs in this group occurred prior to treatment with the WaveLight EX500 excimer laser system. 0 None 0 30 0 30 View
WaveLight EX500 Excimer Laser System - Systemic AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include overall systemic events. 0 None 0 30 0 30 View
WaveLight EX500 Excimer Laser System - Ocular AEs in this group occurred after attempted treatment with the WaveLight EX500 excimer laser system and include ocular events in the study eye. 0 None 2 60 10 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.0 View