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 @ 9:10 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
NCT ID:
NCT02319304
Group ID:
EG000
Title:
Pelvic Radiotherapy With Concurrent Neoadjuvant FOLFOX
Description:
Part I:
FOLFOX: combination of drugs administered in a specific sequence as prescribed below.
* Oxaliplatin: 85 mg/m2 intravenously (IV) over 2 hours
* Leucovorin: 200 mg/m2 IV bolus over 2 hours
* 5-FU: 400 mg/m2 IV bolus over 5-15 minutes, then 2,400 mg/m2 continuous IV infusion over 46-48 hours
Part II:
Low dose fractionated radiation therapy (LDFRT) Intensity-modulated, bone marrow sparing, whole pelvic radiation therapy 40 cGy fractions twice per day delivered at least 4-6 hours apart on the first 2 days of each chemotherapy cycle for a total of 6 cycles
FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}: see arm description
Low dose fractionated radiation therapy (LDFRT): see arm description
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
3
Other Number Affected:
3
Other Number At Risk:
3
Study:
NCT02319304
Results Section:
NCT02319304
Adverse Events Module:
NCT02319304