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 @ 6:48 PM
Ignite Modification Date: 2025-12-25 @ 4:19 PM
NCT ID: NCT02920957
Description: Assessment of adverse events was performed during the study visits. Investigators may be notified of adverse events by the participants outside of the study visits.
Frequency Threshold: 5
Time Frame: None
Study: NCT02920957
Study Brief: Performance Comparison Between Comfilcon A and Senofilcon C Lenses
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Comfilcon A Participants are randomized to wear the comfilcon A lens for one month during either as the first or second intervention. None None 1 87 0 87 View
Senofilcon C Participants are randomized to wear the senofilcon C lens for one month during either as the first or second intervention. None None 0 83 0 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Motocycle Accident NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):