{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","spread":"0","upperLimit":"3.1","value":"1"},{"groupId":"OG001","lowerLimit":"26.8","spread":"26.8","upperLimit":"46.1","value":"36.5"},{"groupId":"OG002","lowerLimit":"30.4","spread":"30.4","upperLimit":"50","value":"40.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"96"},{"groupId":"OG002","value":"97"}],"units":"Participants"}],"description":"Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in participants with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. The MRI or CT imaging results reviewed in a blinded manner by an Independent Review Committee (IRC). Analysis was performed on intent-to-treat (ITT) population defined as all randomized participants who signed informed consent form (ICF).","dispersionType":"95% Confidence Interval","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":"OG000","title":"Placebo"},{"description":"SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).","id":"OG001","title":"SAR302503 400 mg"},{"description":"SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).","id":"OG002","title":"SAR302503 500 mg"}],"paramType":"NUMBER","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 24","title":"Response Rate (RR): Percentage of Participants Who Had a >=35% Reduction From Baseline in Volume of Spleen Size at The End Cycle 6","type":"PRIMARY","unitOfMeasure":"percentage of participants"}