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 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
NCT ID:
NCT03050060
Group ID:
EG000
Title:
Treatment (Nelfinavir, Immunotherapy, Radiation Therapy)
Description:
Beginning 7-14 days prior to start of pembrolizumab, nivolumab, or atezolizumab, patients receive nelfinavir mesylate PO BID on days 1-7 or 1-14 (dependent upon when treatment is started) up to 11-12 weeks. Patients also receive pembrolizumab, nivolumab or atezolizumab IV over 30-60 minutes on day 1. Cycles repeat every 21-28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo hypofractionated radiation therapy over 3-14 days starting after cycle 1 and before cycle 3 of pembrolizumab, nivolumab or atezolizumab. The study will exclude irradiation of liver metastases as an added precaution.
Atezolizumab: Given IV
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy
Laboratory Biomarker Analysis: Correlative studies
Nelfinavir Mesylate: Given PO
Nivolumab: Given IV
Pembrolizumab: Given IV
Deaths Number Affected:
12
Deaths Number At Risk:
None
Serious Number Affected:
10
Serious Number At Risk:
20
Other Number Affected:
20
Other Number At Risk:
20
Study:
NCT03050060
Results Section:
NCT03050060
Adverse Events Module:
NCT03050060