{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"description":"Number of participants with PFS for thalidomide/Dexamethasone vs. VAD with respect to progression free survival in newly diagnosed MM. Progressive Disease (PD): (for patients not in CR) Requires one or more of the following; \\> 25% increase in the level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation.\n\n\\> 25% increase in 24-hour urinary light chain excretion, which must also be an absolute increase of at least 200mg and confirmed on a repeat investigation.\n\n\\>25% increase in plasma cells in a bone marrow aspirate, which also must be an absolute increase of at least 10%. Definite increase in the size of existing lytic lesions or plasmacytomas. Development of new bone lesions or plasmacytomas (except compression fractures). Development of hypercalcemia (corrected calcium \\> 11.5 mg/dL not attributable to other causes).","groups":[{"description":"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one \"cycle\" of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle.","id":"OG000","title":"Active Comparator: VAD Treatment"},{"description":"Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.","id":"OG001","title":"Active Comparator: Thalidomide and Dexamethasone Treatment"}],"paramType":"NUMBER","populationDescription":"All evaluable participants","reportingStatus":"POSTED","timeFrame":"4 Months","title":"Number of Participants With Progression Free Survival (PFS), by Treatment Arm","type":"SECONDARY","unitOfMeasure":"participants"}