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 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
NCT ID:
NCT01951157
Group ID:
EG001
Title:
B - Lurbinectedin (PM01183)
Description:
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amedment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
Deaths Number Affected:
17
Deaths Number At Risk:
None
Serious Number Affected:
9
Serious Number At Risk:
21
Other Number Affected:
20
Other Number At Risk:
21
Study:
NCT01951157
Results Section:
NCT01951157
Adverse Events Module:
NCT01951157