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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 11:57 PM
NCT ID:
NCT01767194
Group ID:
EG001
Title:
Arm II (Temozolomide, Irinotecan Hydrochloride, Dinutuximab)
Description:
Patients receive temozolomide PO on days 1-5, irinotecan hydrochloride over 90 minutes on days 1-5, dinutuximab IV over 10-20 hours on days 2-5, and sargramostim SC or IV over 2 hours on days 6-12.
Dinutuximab: Given IV
Irinotecan Hydrochloride: Given IV
Laboratory Biomarker Analysis: Optional correlative studies
Sargramostim: Given SC or IV
Temozolomide: Given PO
Deaths Number Affected:
15
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
51
Other Number Affected:
39
Other Number At Risk:
51
Study:
NCT01767194
Results Section:
NCT01767194
Adverse Events Module:
NCT01767194