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 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
NCT ID:
NCT03840902
Group ID:
EG001
Title:
cCRT Plus Placebo Followed by Durvalumab
Description:
Participants received Concomitant Chemoradiotherapy (cCRT): Cisplatin/Etoposide (50 mg/m\^2) of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 50 mg/m\^2 intravenously of Etoposide over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT or Carboplatin/Paclitaxel, carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 with 45 mg/m\^2 of Paclitaxel over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT or Cisplatin/Pemetrexed, 50 mg/m\^2 of Cisplatin intravenously over 60 minutes on Days 1, 8, 29, and 36 with 500 mg/m\^2 of Pemetrexed intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT concomitant with Intensity Modulated Radiation Therapy 5 (IMRT 5), fractions per week for about 6 weeks (Total 60 gray \[Gy\]) in combination with intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT followed by intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
31
Serious Number At Risk:
77
Other Number Affected:
72
Other Number At Risk:
77
Study:
NCT03840902
Results Section:
NCT03840902
Adverse Events Module:
NCT03840902