Table 1.

Baseline demographics and disease characteristics in the ASCT-intent subgroup

Denosumab (n = 465)Zoledronic acid (n = 465)All patients (N = 930)
Male 269 (57.8) 278 (59.8) 547 (58.8) 
Age, median (IQR), y 59.0 (54.0-64.0) 59.0 (54.0-64.0) 59.0 (54.0-64.0) 
Race    
 White 380 (81.7) 378 (81.3) 758 (81.5) 
 Asian 66 (14.2) 59 (12.7) 125 (13.4) 
 Black 14 (3.0) 17 (3.7) 31 (3.3) 
 Other 5 (1.1) 11 (2.4) 16 (1.7) 
Geographic region    
 Europe 251 (54.0) 267 (57.4) 518 (55.7) 
 North America 133 (28.6) 134 (28.8) 267 (28.7) 
 Rest of the world 81 (17.4) 64 (13.8) 145 (15.6) 
Bone marrow plasma cell percentage at initial diagnosis, median (IQR) 40.0 (20.0-70.0) 39.0 (20.0-65.0) 40.0 (20.0-68.0) 
ECOG performance status at study entry    
 0 181 (38.9) 171 (36.8) 352 (37.8) 
 1 194 (41.7) 207 (44.5) 401 (43.1) 
 2 90 (19.4) 87 (18.7) 177 (19.0) 
Previous SRE    
 Any 314 (67.5) 314 (67.5) 628 (67.5) 
 Pathological fracture 264 (56.8) 245 (52.7) 509 (54.7) 
 Spinal cord compression 52 (11.2) 68 (14.6) 120 (12.9) 
 Radiation therapy to bone 67 (14.4) 79 (17.0) 146 (15.7) 
 Surgery to bone 69 (14.8) 88 (18.9) 157 (16.9) 
ISS stage at diagnosis    
 I 167 (35.9) 164 (35.3) 331 (35.6) 
 II 166 (35.7) 174 (37.4) 340 (36.6) 
 III 122 (26.2) 115 (24.7) 237 (25.5) 
 Not available 10 (2.2) 12 (2.6) 22 (2.4) 
Prior oral bisphosphonate exposure, median (IQR), months 5.4 (0.5-6.5) 2.5 (0.6-4.2) 3.8 (0.6-5.4) 
Denosumab (n = 465)Zoledronic acid (n = 465)All patients (N = 930)
Male 269 (57.8) 278 (59.8) 547 (58.8) 
Age, median (IQR), y 59.0 (54.0-64.0) 59.0 (54.0-64.0) 59.0 (54.0-64.0) 
Race    
 White 380 (81.7) 378 (81.3) 758 (81.5) 
 Asian 66 (14.2) 59 (12.7) 125 (13.4) 
 Black 14 (3.0) 17 (3.7) 31 (3.3) 
 Other 5 (1.1) 11 (2.4) 16 (1.7) 
Geographic region    
 Europe 251 (54.0) 267 (57.4) 518 (55.7) 
 North America 133 (28.6) 134 (28.8) 267 (28.7) 
 Rest of the world 81 (17.4) 64 (13.8) 145 (15.6) 
Bone marrow plasma cell percentage at initial diagnosis, median (IQR) 40.0 (20.0-70.0) 39.0 (20.0-65.0) 40.0 (20.0-68.0) 
ECOG performance status at study entry    
 0 181 (38.9) 171 (36.8) 352 (37.8) 
 1 194 (41.7) 207 (44.5) 401 (43.1) 
 2 90 (19.4) 87 (18.7) 177 (19.0) 
Previous SRE    
 Any 314 (67.5) 314 (67.5) 628 (67.5) 
 Pathological fracture 264 (56.8) 245 (52.7) 509 (54.7) 
 Spinal cord compression 52 (11.2) 68 (14.6) 120 (12.9) 
 Radiation therapy to bone 67 (14.4) 79 (17.0) 146 (15.7) 
 Surgery to bone 69 (14.8) 88 (18.9) 157 (16.9) 
ISS stage at diagnosis    
 I 167 (35.9) 164 (35.3) 331 (35.6) 
 II 166 (35.7) 174 (37.4) 340 (36.6) 
 III 122 (26.2) 115 (24.7) 237 (25.5) 
 Not available 10 (2.2) 12 (2.6) 22 (2.4) 
Prior oral bisphosphonate exposure, median (IQR), months 5.4 (0.5-6.5) 2.5 (0.6-4.2) 3.8 (0.6-5.4) 

Data are n (%) unless indicated otherwise.

ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range.

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