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 @ 12:31 PM
Ignite Modification Date:
2025-12-25 @ 12:09 PM
NCT ID:
NCT00919061
Group ID:
EG000
Title:
Gemcitabine and Cisplatin Plus Sorafenib
Description:
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
24
Serious Number At Risk:
39
Other Number Affected:
37
Other Number At Risk:
39
Study:
NCT00919061
Results Section:
NCT00919061
Adverse Events Module:
NCT00919061