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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT03466060
Description: None
Frequency Threshold: 5
Time Frame: Throughout the entire duration of the study. Approximately 5-weeks per subject.
Study: NCT03466060
Study Brief: Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
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 - ClearCare Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study. 0 None 0 38 0 38 View
Senofilcon C - OptiFree Subjects that wore the senofilcon C lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study. 0 None 0 38 0 38 View
Etafilcon A - Revitalens Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study. 0 None 0 37 0 37 View
Etafilcon A - Clear Care Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study. 0 None 0 37 0 37 View
Etafilcon A- Optifree Subjects that wore the etaiflcon A lens throughout the entire duration of the study and the OPti-Free solution in one duringeither period 1 or period 2 during the study. 0 None 0 37 0 37 View
Senofilcon A - Revitalens Subjects that wore the senfilcon A lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study. 0 None 0 38 0 38 View
Senofilcon A - ClearCare Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Clear Care solution in one duringeither period 1 or period 2 during the study. 0 None 0 38 0 38 View
Senofilcon A - Opti-Free Subjects that wore the senofilcon A lens throughout the entire duration of the study and the Opti-Free solution in one duringeither period 1 or period 2 during the study. 0 None 0 38 0 38 View
Senofilcon C- Revitalens Subjects that wore the senofilcon C lens throughout the entire duration of the study and the revitalens solution in at least one eye throughout the entire study. 0 None 0 38 0 38 View
Serious Events(If Any):
Other Events(If Any):