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 @ 4:04 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT03960866
Description: All treatment-emergent adverse events (TEAEs)/adverse reactions occurring during the study (ie, once the subject has received 1 dose of study medication) were documented, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
Frequency Threshold: 0
Time Frame: 14 Days
Study: NCT03960866
Study Brief: Safety and Efficacy of Ophthalmic Phentolamine Mesylate in Glaucoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nyxol Ophthalmic Solution 1% 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution 1%: Topical Sterile Ophthalmic Solution 0 None 0 19 5 19 View
Nyxol Ophthalmic Solution Vehicle 1 drop in each eye daily (QD) at or before bedtime (8pm to 10pm) for 14 days Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution 0 None 0 20 1 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Conjunctival Hyperemia SYSTEMATIC_ASSESSMENT Eye disorders None View
Installation Site Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Eye Pruritis SYSTEMATIC_ASSESSMENT Eye disorders None View