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 @ 12:38 AM
NCT ID: NCT05501860
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were reported starting from the time of signing the informed consent until the end of the study assessment (follow up phone call at day 2-5 or day 90 for specular microscopy subjects).
Study: NCT05501860
Study Brief: A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo Sterile Topical Ophthalmic Solution Placebo: Placebo Sterile Topical Ophthalmic Solution 0 None 0 83 10 83 View
AG-920 Articaine Sterile Topical Ophthalmic Solution (AG-920) is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%. AG-920: AG-920 Sterile Topical Ophthalmic Solution 0 None 0 166 38 166 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Instillation site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 25.0 View