A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.
Overall Survival (OS), Patient-reported outcome (PRO)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
No
Bayer Study Director
Study Director
Bayer
United States: Food and Drug Administration
11213
NCT00073307
November 2003
April 2010
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Alexandria, Minnesota 56308 | |
Albany, Georgia 31701 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Eugene, Oregon | |
Milwaukee, Wisconsin | |
Charleston, South Carolina | |
Salt Lake City, Utah 84112 |