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 @ 5:25 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT02939950
Description: Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.
Frequency Threshold: 0
Time Frame: Baseline up to Month 12
Study: NCT02939950
Study Brief: Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bausch + Lomb Samfilcon A Soft Contact Lens Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. 0 None 0 405 22 405 View
Bausch + Lomb Pure Vision Soft Contact Lens Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. 0 None 0 410 14 410 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Peripheral Non-Progressive Non-Infectious Corneal Ulcer SYSTEMATIC_ASSESSMENT Eye disorders No coding applied View
Symptomatic Corneal Infiltrative Event SYSTEMATIC_ASSESSMENT Eye disorders No coding applied View
Corneal Staining greater than or equal to Grade 3 SYSTEMATIC_ASSESSMENT Eye disorders No coding applied View
Ocular Event that necessitates temporary lens discontinuation for atleast two weeks SYSTEMATIC_ASSESSMENT Eye disorders No coding applied View