{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11","upperLimit":"59","value":"31"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"}],"units":"Participants"}],"description":"The primary objective is to determine of the rate of objective response (percentage of patients with an objective response) defined as sustained reduction of monoclonal proteins by more than 25% versus pre-Bexxar level.\n\nAn objective response may be:\n\nMinimal Response (MR) - 25-49% reduction on the level of the serum monoclonal protein for at least 2 determinations.\n\nPartial Response (PR) - 50-89% reduction in the level of the serum monoclonal protein for at least 2 determinations.\n\nComplete Response (CR) - Absence of the original monoclonal protein in serum and urine on at least 2 determinations by immunofixation.","dispersionType":"95% Confidence Interval","groups":[{"description":"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the \"dosimetric\" infusion and the \"therapeutic\" infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose.","id":"OG000","title":"Bexxar Therapeutic"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"3 months","title":"Percentage of Patients With an Objective Response","type":"PRIMARY","unitOfMeasure":"percentage of patients"}