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 @ 3:48 AM
Ignite Modification Date: 2025-12-26 @ 2:35 AM
NCT ID: NCT00762502
Description: None
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT00762502
Study Brief: Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
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 A senofilcon A lenses (test) worn daily bilaterally (in both eyes) for 6 months, replaced weekly OR senofilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow. None None 0 87 13 87 View
Balafilcon A balafilcon A lenses (control) worn daily bilaterally (in both eyes) for 6months, replaced weekly OR balifilcon A toric lenses worn contralaterally for 6 months, replaced weekly. All enrolled subjects are included. Subjects are counted by device, there are some subjects that are counted in both arms that are from the contralateral group, as identified in the participant flow. None None 1 76 9 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Microbial Karatitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Non-Significant Events SYSTEMATIC_ASSESSMENT Eye disorders None View