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 @ 5:03 AM
Ignite Modification Date: 2025-12-26 @ 4:06 AM
NCT ID: NCT01494818
Description: An adverse event was any untoward medical occurrence in a subject administered a test article, regardless of causal relationship with the treatment.
Frequency Threshold: 5
Time Frame: Adverse events were collected for the duration of the study. The safety population includes all participants exposed to test product.
Study: NCT01494818
Study Brief: Evaluation of Marketed Contact Lens Disinfectant Systems on Eyelid Tissues
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CLEAR CARE/AOSEPT Plus Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months None None 2 39 3 39 View
ReNu MultiPlus PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months None None 0 39 0 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toxic reaction to solution SYSTEMATIC_ASSESSMENT Eye disorders None View