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 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
NCT ID:
NCT01336933
Group ID:
EG000
Title:
Treatment (Chemotherapy and Enzyme Inhibitor Therapy)
Description:
Patients receive cyclophosphamide IV and vincristine sulfate IV on day 1, etoposide IV on days 1-3 or PO QD on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with CR or PR, per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.
prednisone: Given PO
cyclophosphamide: Given IV
etoposide: Given PO or IV
vincristine sulfate: Given IV
pralatrexate: Given IV
laboratory biomarker analysis: Correlative studies
comparative genomic hybridization: Correlative studies
gene expression analysis: Correlative studies
nucleic acid sequencing: Correlative studies
mutation analysis: Correlative studies
Deaths Number Affected:
12
Deaths Number At Risk:
None
Serious Number Affected:
13
Serious Number At Risk:
33
Other Number Affected:
19
Other Number At Risk:
33
Study:
NCT01336933
Results Section:
NCT01336933
Adverse Events Module:
NCT01336933