{"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":"FG000","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":"FG001","title":"LDE225 (Sonidegib) 800 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"57"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"35"}],"type":"Patient/guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"14"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"5"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"5"}],"type":"Non-compliance with study treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Study terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"26"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Untreated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"151"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"one patient randomized to LDE225 (sonidegib) 800 mg did not receive study treatment","groupId":"FG001","numSubjects":"1"}],"type":"Untreated"},{"achievements":[{"groupId":"FG000","numSubjects":"52"},{"groupId":"FG001","numSubjects":"89"}],"type":"Patients Cont. to Next Phase of Trial"},{"achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"49"}],"type":"Survival Follow-up"},{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"40"}],"type":"Post-treatment Follow-up"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"151"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All eligible, enrolled patients were randomized in 1:2 ratio to sonidegib treatment with either 200 mg or 800 mg once-daily dose. In total, 230 patients were evaluated as FAS population: 79 and 151 patients randomized to 200mg and 800 mg sonidegib respectively. However, 1 patient randomized to 800 mg sonidegib did not receive study treatment.","recruitmentDetails":"Randomization was stratified across the two treatment arms according to the stage of disease (laBCC or mBCC), histological subtype (non-aggressive or aggressive for laBCC patients) and the regions (Australia, Europe, and North America)."}