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 @ 5:36 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
NCT ID:
NCT04385368
Group ID:
EG001
Title:
Placebo + SoC
Description:
Participants received matching placebo via IV infusion in combination with SoC chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles, followed by matching placebo continued on Day 1 of each 4-week cycle for up to 10 additional cycles until unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
For participants with tumors of squamous histology, permitted SoC chemotherapy was a combination of carboplatin (AUC 6) and paclitaxel 200 mg/m\^2 via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
For participants with tumors of non-squamous tumor histology, permitted SoC chemotherapy regimens were pemetrexed 500 mg/m\^2 in combination with either cisplatin 75 mg/m\^2 or carboplatin AUC 5, all via IV infusion on Day 1 of each 3-week cycle, for 4 cycles.
Deaths Number Affected:
5
Deaths Number At Risk:
None
Serious Number Affected:
10
Serious Number At Risk:
44
Other Number Affected:
44
Other Number At Risk:
44
Study:
NCT04385368
Results Section:
NCT04385368
Adverse Events Module:
NCT04385368