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 @ 5:38 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT03762668
Description: An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study lenses. This analysis population includes all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).
Frequency Threshold: 5
Time Frame: Adverse events were collected (observed or reported) for the duration of the individual's participation in the study, approximately 2 weeks.
Study: NCT03762668
Study Brief: Performance Assessment of a Modified 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
MDACL MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized 0 None 0 59 0 59 View
DACL DACL worn for approximately 1 week, Period 1 or Period 2, as randomized 0 None 0 60 0 60 View
Serious Events(If Any):
Other Events(If Any):