{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6","upperLimit":"80","value":"33"},{"groupId":"OG001","lowerLimit":"6","upperLimit":"80","value":"33"},{"groupId":"OG002","lowerLimit":"51","upperLimit":"100","value":"100"},{"groupId":"OG003","lowerLimit":"21","upperLimit":"94","value":"67"},{"groupId":"OG004","lowerLimit":"24","upperLimit":"76","value":"50"},{"groupId":"OG005","lowerLimit":"29","upperLimit":"67","value":"48"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"23"}],"units":"Participants"}],"description":"Percentage of participants experiencing Grade 1 - Grade 3 treatment-emergent peripheral (sensory) neuropathy events based on CTCAEv3 as reported on case report forms for phase I participants.","dispersionType":"95% Confidence Interval","groups":[{"description":"Combination of everolimus \\& rituximab for 6 cycles\n\nEverolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)","id":"OG000","title":"Phase I Stage A Level 1"},{"description":"Combination of everolimus \\& rituximab for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)","id":"OG001","title":"Phase I Stage A Level 2"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 5 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG002","title":"Phase I Stage B Level 1"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG003","title":"Phase I Stage B Level 2"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG004","title":"Phase I Dose Expansion"},{"description":"Combination of everolimus \\& rituximab with bortezomib for 6 cycles\n\nEverolimus 10 mg: Taken orally on a daily basis x 28 days (1 cycle)\n\nRituximab 375 mg/Kg: Given intravenously on days 1, 8, 15 and 22 of Cycle 1 and Cycle 4 only (1 cycle = 28 days)\n\nBortezomib 1.6 mg/m\\^2: Given intravenously on days 1, 8 and 15 of every cycle (1 cycle = 28 days)","id":"OG005","title":"Phase II"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Adverse events were assessed each cycle (ever 28 days) for 6 cycles then every 3 months on maintenance. Duration of therapy for the Phase I study up to 41 months.","title":"Treatment-Emergent Sensory Neuropathy Rate [Phase I]","type":"SECONDARY","unitOfMeasure":"percentage of participants"}