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 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 1:18 PM
NCT ID:
NCT03754959
Group ID:
EG002
Title:
BI 1358894 10 mg + Midazolam
Description:
Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast.
Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast.
On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
8
Other Number Affected:
4
Other Number At Risk:
8
Study:
NCT03754959
Results Section:
NCT03754959
Adverse Events Module:
NCT03754959