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 @ 5:29 PM
Ignite Modification Date: 2025-12-25 @ 3:03 PM
NCT ID: NCT05470868
Description: The manifested adverse events during the conduction of this trial were obtained during trial visits and reported in the electronic CRF, where the clinical team of the center included the information from source documents. These were previously checked by the monitor team, pharmacovigilance specialist, and the medical specialist part of the sponsor's crew to verify concordance with what was stipulated in the protocol.
Frequency Threshold: 0
Time Frame: From day 1 (basal visit) to final visit on day 10 (±1 days)
Study: NCT05470868
Study Brief: Safety and Tolerability of PRO-185
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-185 Healthy volunteers will apply one drop of PRO-185 ophthalmic solution (naphazoline / hypromellose) on both eyes, QID (four times per day) for 8 days. Naphazoline / Hypromellose Ophthalmic: Naphazoline 0.03% / Hypromellose 0.2% 0 None 0 22 9 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Burning sensation SYSTEMATIC_ASSESSMENT Eye disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tearing SYSTEMATIC_ASSESSMENT Eye disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Irritation in the area of instillation SYSTEMATIC_ASSESSMENT Endocrine disorders None View
conjunctival hyperemia SYSTEMATIC_ASSESSMENT Eye disorders None View
punctate keratitis SYSTEMATIC_ASSESSMENT Eye disorders None View