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 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
NCT ID:
NCT01287520
Group ID:
EG006
Title:
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)
Description:
* Cycle 1 Day 1 of 28 day cycle: pretreated with 50 mg ranitidine intravenous, 80 mg LY2090314 by intravenous infusion.
* Cycle 1 Day 8 of 28 day cycle: 500 mg/m\^2 Pem by intravenous infusion followed by AUC 6mg/mL \* min Carb intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 by intravenous infusion.
* Cycle 2 Day 1 of 21 day cycle: AUC 6 mg/mL \* min Carb by intravenous infusion followed by 500 mg/m\^2 Pem intravenous infusion.
* Cycle 3 up to Cycle 9: Day 1 of 21 day cycle: 500 mg/m\^2 Pem by intravenous infusion followed by AUC 6 mg/mL \* min Carb by intravenous infusion followed by 50 mg ranitidine intravenous pretreatment and 80 mg LY2090314 intravenous infusion.
Based on I2H-MV-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine was given as a pretreatment to LY2090314 as prophylaxis for stomach pain.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
2
Other Number Affected:
2
Other Number At Risk:
2
Study:
NCT01287520
Results Section:
NCT01287520
Adverse Events Module:
NCT01287520