Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
NCT ID:
NCT04675151
Group ID:
EG001
Title:
POS 0.75% First, Then LDP Vehicle
Description:
Participants received Phentolamine Ophthalmic Solution 0.75%: 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist, starting on the night of Visit 1 and subsequently taken daily for 3 to 4 consecutive days immediately prior to Visit 2.
Then, after 3-4 days of initial administration of 0.75% POS, participants received Low-Dose Pilocarpine Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.
Treatment 1 (Nyxol or placebo) was administered in both eyes (OU)by the subject. Treatment 2 was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.
Treatment 1 (0.75% POS) was administered in both eyes (OU) by the subject. Treatment 2 (LDP Vehicle) was administered OU by a designated, unmasked site staff member, distinct from the site staff member recording assessments.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
30
Other Number Affected:
6
Other Number At Risk:
30
Study:
NCT04675151
Results Section:
NCT04675151
Adverse Events Module:
NCT04675151