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 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
NCT ID:
NCT00136435
Group ID:
EG000
Title:
Induction, CNS, and Intensification With Pharmacokinetically Individualized Doses of L-asparaginase
Description:
prednisone: Induction Phase: Orally days 1-28
doxorubicin: Induction Phase: Intravenously days 1 and 2 CNS Therapy: Intravenously day 1 Intensification: Given day 1 of each cycle
vincristine: Induction: Intravenously days 1, 8, 15, and 22. If complete remission not achieved, will be given on days 29, 36 and 43.
CNS Therapy: Intravenously day 1. Intensification: Intravenously day 1 of each cycle. Continuation: Intravenously day 1 of each cycle
methotrexate: Induction: Intravenously day 3. CNS Therapy: Intrathecally 4x over two weeks Intensification: Intrathecally every 18 weeks Continuation: Intravenously weekly and intrathecally every 18 weeks
asparaginase: Induction: Given into the muscle on day 5
dexamethasone: Intensification: Orally days 1-5 of each cycle
cranial radiation: 10 daily treatments during CNS phase
leucovorin: Induction: Intravenously/orally 36 hours after methotrexate
cytarabine: Induction: Intrathecally days 1, 15, 29 CNS Therapy: Intrathecally 4x over 2 weeks Intensification: Intrathecally every 18 weeks Continuation: Intrathecally every 18 weeks
hydrocortisone: Induction: Intrathecally days 15 and 29. Intensification: Intrathecally every 18 weeks. Continuation: Intrathecally every 18 weeks.
6-mercaptopurine (6-MP): CNS Therapy: Orally days 1-14. Intensification: Orally on days 1-14. Continuation: Orally on days 1-14.
e. coli L-asparaginase: Intensification: Given in to the muscle weekly.
Deaths Number Affected:
40
Deaths Number At Risk:
None
Serious Number Affected:
98
Serious Number At Risk:
98
Other Number Affected:
0
Other Number At Risk:
98
Study:
NCT00136435
Results Section:
NCT00136435
Adverse Events Module:
NCT00136435