{"groups":[{"description":"Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.","id":"FG000","title":"GM-CSF"},{"description":"Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.","id":"FG001","title":"Talimogene Laherparepvec"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"95"},{"groupId":"FG001","numSubjects":"190"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"141"},{"groupId":"FG001","numSubjects":"296"}],"type":"STARTED"},{"achievements":[{"comment":"All participants who were randomized once to study treatment","groupId":"FG000","numSubjects":"141"},{"comment":"Participants who were randomized once to study treatment; excludes 1 participant randomized 3 times","groupId":"FG001","numSubjects":"295"}],"type":"Intent-to-treat Population"},{"achievements":[{"groupId":"FG000","numSubjects":"127"},{"groupId":"FG001","numSubjects":"292"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"97"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"111"},{"groupId":"FG001","numSubjects":"199"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Patients were assigned at a 2:1 ratio using central random assignment to receive intralesional talimogene laherparepvec or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). Randomization was stratified by site of first recurrence, presence of liver metastases, disease stage, and prior nonadjuvant systemic treatment.","recruitmentDetails":"Eligible patients were adults with histologically confirmed, not surgically resectable, stage IIIB - IV melanoma suitable for direct or ultrasound-guided injection.\n\nAmong those randomized, the first patient enrolled 29 April 2009 and last patient enrolled 8 June 2011.\n\n1 patient randomized 3 times is counted once under talimogene laherparepvec."}