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:
EG002
Title:
C - Gemcitabine + Lurbinectedin (PM01183)
Description:
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amedment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
Deaths Number Affected:
21
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
25
Other Number Affected:
25
Other Number At Risk:
25
Study:
NCT01951157
Results Section:
NCT01951157
Adverse Events Module:
NCT01951157