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 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
NCT ID:
NCT02455557
Group ID:
EG000
Title:
Treatment (SurVaxM, Temozolomide)
Description:
Patients receive the first priming dose of SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC within 7-28 days after completion of chemoradiation. Treatment repeats every 2 weeks for a total of 4 doses in the vaccine priming phase and then every 12 weeks during the adjuvant phase in the absence of disease progression or unacceptable toxicity. Patients also receive standard adjuvant temozolomide PO or IV on days 1-5. Treatment repeats every 28 days for 6 courses or more (at the discretion of the investigator) in the absence of disease progression or unacceptable toxicity. Patients may then receive maintenance SVN53-67/M57-KLH peptide vaccine in emulsion with montanide ISA 51 SC and sargramostim SC every 12 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Montanide ISA 51 VG: Given SC
Sargramostim: Given SC
SVN53-67/M57-KLH Peptide Vaccine: Given SC
Temozolomide: Given PO or IV
Deaths Number Affected:
36
Deaths Number At Risk:
None
Serious Number Affected:
22
Serious Number At Risk:
66
Other Number Affected:
65
Other Number At Risk:
66
Study:
NCT02455557
Results Section:
NCT02455557
Adverse Events Module:
NCT02455557