{"groups":[{"description":"Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.","id":"FG000","title":"TCC (Transitional Cell Carcinoma) Cohort"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"}],"type":"Ineligibility"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Alternative treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"performance status was deteiorating"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"27"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"}],"type":"Eligible and Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"15"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study was activated on 10/26/2005. The TCC (transitional cell carcinoma) cohort was suspended for an efficacy evaluation on 10/30/2006 after reaching its first stage accrual goal. A total of 27 patients entered the TCC cohort, and no patient entered the non-TCC cohort. The study was terminated on March 10th, 2008."}