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 @ 10:02 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
NCT ID:
NCT03467932
Group ID:
EG006
Title:
Cohort B: ORMD-0801 16 mg Once Daily - QD
Description:
ORMD-0801 16 mg once daily - QHS: dosed in the evening prior to bedtime (@ 10 PM ± 90 minutes)
Cohort B: ORMD-0801: Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.
Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
18
Other Number Affected:
1
Other Number At Risk:
18
Study:
NCT03467932
Results Section:
NCT03467932
Adverse Events Module:
NCT03467932