NCT00073307 · MORE INFO

Limitations, agreements, and source contact

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer · Source last updated 2014-02-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement

other Details: The agreed point of publication is 12-18 months after database lock at the earliest. * Bayer will have up to 30/45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). * No publication of single center data should be done prior of publication if multi -center data.
pi Sponsor Employee: false
restriction Type: OTHER
restrictive Agreement: true

limitations And Caveats

description: Per final PFS data (N=769) study unblinded; placebo-randomized subjects switched to sorafenib \~31May2005 (N=216) that diluted final OS, sorafenib treatment effect. Final ITT, N=903, reported safety data include additional data and cleaning.

point Of Contact

Complete source fields

certain Agreement

other Details: The agreed point of publication is 12-18 months after database lock at the earliest. * Bayer will have up to 30/45 days to review publications, and may request an additional publication delay of up to 60 days to allow for filing a Patent Application (if applicable). * No publication of single center data should be done prior of publication if multi -center data.
pi Sponsor Employee: false
restriction Type: OTHER
restrictive Agreement: true

limitations And Caveats

description: Per final PFS data (N=769) study unblinded; placebo-randomized subjects switched to sorafenib \~31May2005 (N=216) that diluted final OS, sorafenib treatment effect. Final ITT, N=903, reported safety data include additional data and cleaning.

point Of Contact

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice