{"groups":[{"description":"Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.","id":"FG000","title":"Placebo"},{"description":"SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).","id":"FG001","title":"SAR302503 400 mg"},{"description":"SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).","id":"FG002","title":"SAR302503 500 mg"},{"description":"At the end of cycle 6, participants were crossed-over to SAR302503 400 mg until disease progression or unacceptable toxicity.","id":"FG003","title":"Placebo Then SAR302503 400 mg"},{"description":"At the end of cycle 6, participants were crossed-over to SAR302503 500 mg until disease progression or unacceptable toxicity.","id":"FG004","title":"Placebo Then SAR302503 500 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Withdrawal by participant"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Randomized, but not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Poor compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"35"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Other than specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Participant request"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"45"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Study termination by sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Early crossover"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"96"},{"groupId":"FG002","numSubjects":"97"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"95"},{"groupId":"FG001","numSubjects":"96"},{"groupId":"FG002","numSubjects":"97"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"96"},{"groupId":"FG002","numSubjects":"97"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomization until end of Cycle 6"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"comment":"Crossover from placebo","groupId":"FG003","numSubjects":"35"},{"comment":"Crossover from placebo","groupId":"FG004","numSubjects":"36"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"35"},{"groupId":"FG004","numSubjects":"36"}],"type":"NOT COMPLETED"}],"title":"Crossover After Cycle 6"}],"preAssignmentDetails":"Of 351 screened participants, 62 were screen failures and 289 were randomized.","recruitmentDetails":"The study was conducted at 101 sites in 25 countries. A total of 351 participants were screened between 22 December 2011 and 24 August 2012."}