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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
NCT ID:
NCT01235793
Group ID:
EG000
Title:
DRBEAT Regimen
Description:
Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m\^2 (cumulative total dose of 1250 mg/m\^2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
Deaths Number Affected:
6
Deaths Number At Risk:
None
Serious Number Affected:
6
Serious Number At Risk:
11
Other Number Affected:
11
Other Number At Risk:
11
Study:
NCT01235793
Results Section:
NCT01235793
Adverse Events Module:
NCT01235793