{"groups":[{"description":"Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).","id":"FG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Subjects received matching placebo tablets administered orally twice a day. \\[until \\~31 May 2005\\]","id":"FG001","title":"Placebo"},{"description":"Subjects received matching placebo tablets administered orally twice a day(as of \\~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).","id":"FG002","title":"Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Non-compliant with Study medication"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Unknown reason."},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol driven decision point"},{"reasons":[{"groupId":"FG000","numSubjects":"165"},{"groupId":"FG001","numSubjects":"114"},{"groupId":"FG002","numSubjects":"0"}],"type":"entered Open Label (OL); Sorafenib only"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Subject did not receive treatment"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"451"},{"groupId":"FG001","numSubjects":"452"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"451"},{"groupId":"FG001","numSubjects":"451"},{"groupId":"FG002","numSubjects":"0"}],"type":"Participants Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"254"},{"groupId":"FG001","numSubjects":"299"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"197"},{"groupId":"FG001","numSubjects":"153"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Double-Blind (DB, as of ~31May2005)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"19"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"28"}],"type":"Study terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Per Investigator, not protocol driven"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Switched to commercial drug"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"}],"type":"Switched to commercial drug (code error)"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Missing"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"9"}],"type":"No record of treatment discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"83"}],"type":"Did not enter OL/ Sorafenib only phase"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"254"},{"comment":"Placebo treatment ended \\~ 31May2005. Those who continued, switched to receive Sorafenib.","groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"299"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"219"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"216"}],"type":"Entered OL With Sorafenib Only Phase"},{"achievements":[{"groupId":"FG000","numSubjects":"120"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"143"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"156"}],"type":"NOT COMPLETED"}],"title":"Open Label-Sorafenib Only [30Jun2008]"}],"preAssignmentDetails":"Enrollment included outpatients with documented unresectable and/or metastatic RCC (Renal Cell Carcinoma), and subjects who had 1 prior systemic therapy for advanced disease on which the subject progressed, at least 1 unidimensional measurable lesion, intermediate or low Motzer risk score, life expectancy of 12 weeks.","recruitmentDetails":"From randomization start on 01 Dec 2003 to 31 May 2005 \\[last subject randomized\\]. One subject randomized in Placebo did not receive treatment. This study was conducted at 120 centers from 19 countries."}