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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT01561560
Description: An adverse event was defined as an event that caused, or had the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons.
Frequency Threshold: 5
Time Frame: Adverse events were collected for the duration of the study. The safety population includes all participants enrolled and exposed to Test Article.
Study: NCT01561560
Study Brief: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact 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
DAILIES TOTAL1 Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks None None 0 119 0 119 View
TRUEYE Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks None None 0 121 0 121 View
Serious Events(If Any):
Other Events(If Any):