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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
NCT ID:
NCT00789958
Group ID:
EG000
Title:
Adjuvant Chemotherapy + Chemoradiotherapy
Description:
Adjuvant Chemotherapy:
Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle.
Chemoradiotherapy:
Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
2
Serious Number At Risk:
79
Other Number Affected:
78
Other Number At Risk:
79
Study:
NCT00789958
Results Section:
NCT00789958
Adverse Events Module:
NCT00789958