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 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
NCT ID:
NCT02621151
Group ID:
EG000
Title:
Pembrolizumab, Gemcitabine, and RT
Description:
* Lead-in single dose Pembrolizumab 200 mg, intravenously (IV)
* Transurethral Resection of Bladder Tumor (TURBT) at pre-RT (maximal) and completion of therapy (diagnostic)
* External Beam Radiation Therapy (EBRT) - 52 Gy in 20 fractions over 4 weeks (1 fraction = 2.6 Gy)
* Gemcitabine 27 mg/m\^2 IV twice weekly for 4 weeks concurrent with EBRT
* Pembrolizumab 200 mg IV every 3 weeks for total 3 doses starting day 1 of EBRT
Pembrolizumab
Transurethral Resection of Bladder Tumor
Gemcitabine
External Beam Radiation Therapy
Deaths Number Affected:
16
Deaths Number At Risk:
None
Serious Number Affected:
15
Serious Number At Risk:
54
Other Number Affected:
54
Other Number At Risk:
54
Study:
NCT02621151
Results Section:
NCT02621151
Adverse Events Module:
NCT02621151