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 @ 4:00 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT04158466
Description: Adverse events were not coded, therefore source vocabulary is not applicable.
Frequency Threshold: 5
Time Frame: 3 months
Study: NCT04158466
Study Brief: A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Kalifilcon A Daily Disposable Contact Lenses Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens 0 None 0 124 0 124 View
Biotrue ONEday Daily Disposable Contact Lenses Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens 0 None 0 127 0 127 View
Serious Events(If Any):
Other Events(If Any):