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 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
NCT ID:
NCT04560166
Group ID:
EG000
Title:
Naxitamab and GM-CSF in Combination With Irinotecan and Temozolomide
Description:
A treatment cycle is 21 days. The patients will receive irinotecan 50 mg/m2/day IV and temozolomide 100 mg/m2/day orally (both on Days 1-5) in combination with naxitamab 2.25 mg/kg/day IV (Days 2, 4, 8 and 10) (total 9 mg/kg per cycle), and GM-CSF 250 ug/m2/day sc, (Days 6-10).
Patients will receive up to 18 IT cycles after enrollment. Naxitamab and GM-CSF will be given for at least 8 cycles.
Naxitamab and GM-CSF in combination with irinotecan and temozolomide: • Irinotecan, solution for infusion (20 mg/mL)
* Temozolomide, capsules (5 mg, 20 mg and 100 mg)
* The humanized immunoglobulin isotype G (IgG1) monoclonal antibody (mAb) naxitamab, solution for infusion (4 mg/mL)
* Sargramostim (GM-CSF), lyophilized 250 µg single use vial (250 µg/vial)
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
2
Other Number Affected:
2
Other Number At Risk:
2
Study:
NCT04560166
Results Section:
NCT04560166
Adverse Events Module:
NCT04560166