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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
NCT ID:
NCT05092360
Group ID:
EG003
Title:
Investigator's Choice Chemotherapy
Description:
Investigator's choice chemotherapy includes one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator pre-selected the Investigator's choice treatment before the randomization of each participant.
Pegylated Liposomal Doxorubicin (PLD): 40 mg/m\^2; Day 1 of 28-day cycles; IV infusion; 1 mg/min (Cycle 1); 60 min infusion (Cycles 2+).
Paclitaxel: 80 mg/m\^2; Days 1, 8, 15, and 22 of 28-day cycles; IV infusion over 60 min.
Topotecan: 4 mg/m\^2; Days 1, 8, and 15 of 28-day cycles; or 1.25 mg/m2, Days 1 through 5 of 21-day cycles; IV infusion over 30 min.
Gemcitabine: 1,000 mg/m\^2; Days 1 and 8 of 21-day cycles; IV infusion over 30 min.
Deaths Number Affected:
105
Deaths Number At Risk:
None
Serious Number Affected:
51
Serious Number At Risk:
190
Other Number Affected:
171
Other Number At Risk:
190
Study:
NCT05092360
Results Section:
NCT05092360
Adverse Events Module:
NCT05092360