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 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
NCT ID:
NCT03817320
Group ID:
EG001
Title:
Ixazomib Dose Level 2 (Stratum A)
Description:
Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.
Deaths Number Affected:
3
Deaths Number At Risk:
None
Serious Number Affected:
14
Serious Number At Risk:
20
Other Number Affected:
20
Other Number At Risk:
20
Study:
NCT03817320
Results Section:
NCT03817320
Adverse Events Module:
NCT03817320