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 @ 3:34 PM
Ignite Modification Date: 2025-12-25 @ 1:47 PM
NCT ID: NCT06363292
Description: None
Frequency Threshold: 0
Time Frame: Day 1 (Start of product application) to Day 12 (safety call)
Study: NCT06363292
Study Brief: Study to Evaluate the Safety and Tolerability of PRO-231 Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PRO-231 * PRO-231: Moxifloxacin 0.5% Ophthalmic solution. * Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye). * Route of administration: Topical ophthalmic. PRO-231: Moxifloxacin 0.5% Ophthalmic solution. 0 None 0 18 3 18 View
VIGAMOXI® * VIGAMOXI® :Moxifloxacin 0.5% Ophthalmic Solution. * Dosage: 1 drop every 6 hours (3 daily applications \[TID\], in the right eye). * Route of administration: Topical ophthalmic. VIGAMOXI®: Moxifloxacin 0.5% Ophthalmic solution. 0 None 0 19 9 19 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Patient-reported conjunctival redness SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry eye sensation SYSTEMATIC_ASSESSMENT Eye disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Heaviness sensation (eyelids) SYSTEMATIC_ASSESSMENT Eye disorders None View