{"analyses":[{"ciPctValue":"95","groupDescription":"The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.","groupIds":["OG000","OG001"],"nonInferiorityComment":"ANOVA","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","pValue":"<0.025","pValueComment":"Bonferroni adjusted p-value for multiple comparisons.","statisticalComment":"This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.","statisticalMethod":"ANOVA","testedNonInferiority":true}],"anticipatedPostingDate":"2011-02","classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.5","value":"2.3"},{"groupId":"OG001","spread":"2.2","value":"1.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"description":"The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (\\<=60 versus \\>60).Participants who received thalidomide also received low-molecular weight heparin","id":"OG000","title":"Usual Care"},{"description":"Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (\\<=60 versus \\>60). Participants who received thalidomide also received low-molecular weight heparin.","id":"OG001","title":"Exercise"}],"paramType":"MEAN","populationDescription":"For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).","reportingStatus":"POSTED","timeFrame":"up to 15 weeks","title":"Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)","type":"PRIMARY","unitOfMeasure":"RBC Transfusions"}