{"denoms":[{"counts":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"39"}],"units":"Participants"}],"groups":[{"description":"Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles","id":"BG000","title":"Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)"},{"description":"Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles","id":"BG001","title":"Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)"},{"description":"Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles","id":"BG002","title":"Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"18"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"21"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"57","upperLimit":"80","value":"68"},{"groupId":"BG001","lowerLimit":"58","upperLimit":"76","value":"67"},{"groupId":"BG002","lowerLimit":"51","upperLimit":"80","value":"64"},{"groupId":"BG003","lowerLimit":"51","upperLimit":"80","value":"66"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"18"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"21"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"36"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"}],"title":"Black"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}],"title":"Not reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"8"}],"title":"PS 0"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"29"}],"title":"PS 1"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}],"title":"PS 2"}]}],"description":"ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG PS","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}],"title":"Non-secretory"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}],"title":"Oligosecretory"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"36"}],"title":"Secretory"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Multiple myeloma type at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"12"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"24"}],"title":"Stage III"}]}],"description":"Stage I: small number of myeloma cells. All are present:\n\n* Hemoglobin \\>100 g/L\n* Blood calcium \\<2.8 mmol/L\n* No areas of bone damage or a solitary plasmacytoma of the bone\n* Immunoglobulin G (IgG) \\<50 g/L\n* Immunoglobulin A (IgA) \\<30 g/L\n* Urine M-protein \\<4 g\n\nStage II: Moderate number of myeloma cells. The features are between stage 1 and 3\n\nStage III: Large number of myeloma cells. One/more are present:\n\n* Hemoglobin \\<85 g/L\n* Blood calcium \\>2.8 mmol/L\n* Several areas of bone damage\n* IgG \\>70 g/L\n* IgA \\>50 g/L\n* Urine M-protein \\>12 g","paramType":"COUNT_OF_PARTICIPANTS","title":"Durie-Salmon stage at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"12"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"24"}],"title":"Stage III"}]}],"description":"Stage I: small number of myeloma cells. All are present:\n\n* Hemoglobin more than 100 g/L\n* Blood calcium less than 2.8 mmol/L\n* No areas of bone damage or a solitary plasmacytoma of the bone\n* IgG less than 50 g/L\n* IgA less than 30 g/L\n* Urine M-protein less than 4 g\n\nStage II: Moderate number of myeloma cells. The features are between stage 1 and 3\n\nStage III: Large number of myeloma cells. One/more are present:\n\n* Hemoglobin less than 85 g/L\n* Blood calcium more than 2.8 mmol/L\n* Several areas of bone damage\n* IgG more than 70 g/L\n* IgA more than 50 g/L\n* Urine M-protein more than 12 g","paramType":"COUNT_OF_PARTICIPANTS","title":"Durie-Salmon stage at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"30"}],"title":"Substage A"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"9"}],"title":"Substage B"}]}],"description":"The stages of multiple myeloma are further divided according to creatinine level in the blood, which shows how well the kidneys are working.\n\nSubstage A: Kidney function is normal. Creatinine level is less than 180 µmol/L.\n\nSubstage B: Kidney function is abnormal. Creatinine level is 180 µmol/L or more.","paramType":"COUNT_OF_PARTICIPANTS","title":"Durie-Salmon subclassification at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"14"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"6"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"10"}],"title":"Stage III"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"9"}],"title":"Unknown"}]}],"description":"The International Staging System uses the results of 2 blood tests: albumin and beta-2-microglobulin level.\n\nStage 1: Beta-2-microglobulin level less than 3.5 mg/L and albumin level more equal than 35 g/L.\n\nStage 2: Beta-2-microglobulin level less than 3.5 mg/L and Albumin level less than 35 g/L or beta-2-microglobulin level is more than 3.5 mg/L but less than 5.5 mg/L and any albumin level.\n\nStage 3: Beta-2-microglobulin is 5.5 mg/L or more and any albumin level.","paramType":"COUNT_OF_PARTICIPANTS","title":"International Staging System at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"15"}],"title":"Relapsed"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"24"}],"title":"Total refractory"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Disease status with respect to last prior therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}],"title":"CR"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"7"}],"title":"VGPR"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"12"}],"title":"PR"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}],"title":"SD"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"9"}],"title":"PD"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"5"}],"title":"UK"}]}],"description":"CR, complete response; PD, progressive disease; PR, partial response; RD, recommended dose; SD, stable disease; UK, unknown; VGPR, very good partial response.","paramType":"COUNT_OF_PARTICIPANTS","title":"Best response to last prior anticancer therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"55.5","upperLimit":"81.7","value":"70.9"},{"groupId":"BG001","lowerLimit":"53.0","upperLimit":"80.9","value":"65.1"},{"groupId":"BG002","lowerLimit":"46.2","upperLimit":"90.0","value":"72.0"},{"groupId":"BG003","lowerLimit":"46.2","upperLimit":"90.0","value":"70.8"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Weight","unitOfMeasure":"Kg"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.5","upperLimit":"1.9","value":"1.8"},{"groupId":"BG001","lowerLimit":"1.6","upperLimit":"2.0","value":"1.7"},{"groupId":"BG002","lowerLimit":"1.4","upperLimit":"2.1","value":"1.8"},{"groupId":"BG003","lowerLimit":"1.4","upperLimit":"2.1","value":"1.8"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Body surface area","unitOfMeasure":"m^2"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"26","upperLimit":"150","value":"65.3"},{"groupId":"BG001","lowerLimit":"32","upperLimit":"133","value":"55.8"},{"groupId":"BG002","lowerLimit":"29","upperLimit":"196","value":"64.5"},{"groupId":"BG003","lowerLimit":"26","upperLimit":"196","value":"64.5"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time from diagnosis to first infusion","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.4","upperLimit":"16.5","value":"1.6"},{"groupId":"BG001","lowerLimit":"0.7","upperLimit":"5.9","value":"5.3"},{"groupId":"BG002","lowerLimit":"0.4","upperLimit":"53.9","value":"1.6"},{"groupId":"BG003","lowerLimit":"0.4","upperLimit":"53.9","value":"1.6"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time from last progressive disease to first infusion","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1","upperLimit":"4","value":"2"},{"groupId":"BG001","lowerLimit":"1","upperLimit":"9","value":"2"},{"groupId":"BG002","lowerLimit":"1","upperLimit":"9","value":"5"},{"groupId":"BG003","lowerLimit":"1","upperLimit":"9","value":"4"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Lines of prior chemotherapy","unitOfMeasure":"lines of chemotherapy"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"3","upperLimit":"11","value":"6.5"},{"groupId":"BG001","lowerLimit":"2","upperLimit":"11","value":"5.0"},{"groupId":"BG002","lowerLimit":"2","upperLimit":"15","value":"8.0"},{"groupId":"BG003","lowerLimit":"2","upperLimit":"15","value":"7.0"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Agents of prior chemotherapy","unitOfMeasure":"Agents of chemotherapy"}]}