{"denoms":[{"counts":[{"groupId":"BG000","value":"21"}],"units":"Participants"}],"groups":[{"description":"Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.","id":"BG000","title":"PTK787/ZK 222584"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"38","upperLimit":"76","value":"57"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"14"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Stage IA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Stage IIA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Stage IIIA"}],"description":"* Stage I:Hemoglobin (hgb) level \\>10.5 g/dL \\& calcium level is normal or ≤12 mg/dL \\& Low M-protein levels (IgG level is \\<5 g/dL; IgA level \\<3 g/dL) \\& Urine light chains \\<4 g per 24 hours, \\& Bone X-ray normal bone structure or a solitary bone plasmacytoma\n* Stage IIA:Levels of hgb, calcium, M-protein and Bence Jones protein fall somewhere between stages I and III \\& No kidney failure (creatinine ≤2 mg/dL)\n* Stage III: High M protein (IgG is\\>7 g/dL; IgA is \\>5g/dL) \\& Urine light chains \\>12 g per 24 hours \\& hgb \\<8.5 g/dL \\& calcium \\>2 m/dL) \\& X-ray studies of bone \\>3 lytic bone lesions","paramType":"NUMBER","title":"Durie-Salmon stage at study entry","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}]}],"title":"Stage I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"Stage II"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"title":"Stage III"}],"description":"* Stage I:Beta 2-microglobulin level \\<3.5 mg/L \\& Albumin level ≥3.5 g/dL\n* Stage II Beta 2-microglobulin level \\<3.5 g/L \\& Albumin level \\<3.5 g/dL OR Beta 2-microglobulin level is 3.5 to 5.5 mg/L\n* Stage III Beta 2-microglobulin level is ≥5.5 mg/L","paramType":"NUMBER","title":"International Staging System (ISS) at study entry","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.2","upperLimit":"5.65","value":"2.3"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Beta-2 Microglobulin at study entry","unitOfMeasure":"mg/L"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"}]}],"title":"IgG"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"IgA"}],"paramType":"NUMBER","title":"Paraprotein at study entry","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0","upperLimit":"2.4","value":"0.5"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Serum M-spike at study entry","unitOfMeasure":"g/dL"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0","upperLimit":"15","value":"5"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Bone marrow aspirate plasma","unitOfMeasure":"percentage of cells at study entry"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}],"title":"Normal karyotype"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"title":"Monosomy 13"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"title":"Hypodiploid karyotype with t(11;14)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}]}],"title":"Monosomy 13 and t(4:14)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}],"title":"Others"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"title":"No available cytogenetics"}],"paramType":"NUMBER","title":"Conventional cytogenetics","unitOfMeasure":"participants"}]}