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 @ 10:30 PM
Ignite Modification Date:
2025-12-25 @ 8:03 PM
NCT ID:
NCT02766335
Group ID:
EG000
Title:
Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)
Description:
Arm I- Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.
Arm III-For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed.
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Arm III
Durvalumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Deaths Number Affected:
58
Deaths Number At Risk:
None
Serious Number Affected:
27
Serious Number At Risk:
68
Other Number Affected:
66
Other Number At Risk:
68
Study:
NCT02766335
Results Section:
NCT02766335
Adverse Events Module:
NCT02766335