{"denoms":[{"counts":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"151"},{"groupId":"BG002","value":"230"}],"units":"Participants"}],"groups":[{"description":"The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.","id":"BG000","title":"LDE225 (Sonidegib) 200 mg"},{"description":"The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.","id":"BG001","title":"LDE225 (Sonidegib) 800 mg"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"15.67","value":"65.6"},{"groupId":"BG001","spread":"14.59","value":"63.6"},{"groupId":"BG002","spread":"14.96","value":"64.3"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"86"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"144"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"Black"},{"categories":[{"measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"145"},{"groupId":"BG002","value":"216"}]}],"title":"Caucasian"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"13"}]}],"title":"Other"}],"paramType":"NUMBER","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"}],"populationDescription":"The full analysis set (FAS) comprised all patients who were assigned study treatment irrespective of receiving it (all randomized patients). Patients were classified according to the treatment they were assigned in accordance with the intention-to-treat (ITT) principle."}