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 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT02625233
Description: NCT02625233 is a continuation of NCT02515994. Each study was approximately 3 months duration for each subject(i.e. if a subject was enrolled into both studies they wore the lens a total of 6 months). Refer to the adverse event information for study NCT02515994 for the previous 3 months.
Frequency Threshold: 5
Time Frame: Throught the duration of the study. Approximately 3 months per subject.
Study: NCT02625233
Study Brief: Clinical Long-Term Evaluation of Approved and Investigational 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
Senofilcon C Subjects that wore the senofilcon C lens throughout the entire duration of the study. None None 0 49 0 49 View
Comfilcon A Subjects that wore the comfilcon A lens throughout the entire duration of the study. None None 0 56 0 56 View
Serious Events(If Any):
Other Events(If Any):