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 @ 12:53 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT03586167
Description: Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population included all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set), based on treatment-specific exposure.
Frequency Threshold: 5
Time Frame: Dispense through study completion, an average of 1 month (30 days)
Study: NCT03586167
Study Brief: Clinical Performance of a Monthly Replacement Silicone Hydrogel 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
LID014341 LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis 0 None 0 58 0 58 View
Biofinity Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis 0 None 0 28 0 28 View
Serious Events(If Any):
Other Events(If Any):