Sociodemographic / clinical characteristics | Study part | p-value** | ||
---|---|---|---|---|
Part A (n = 70) | Part B (n = 102) | Total (n = 172) | ||
Gender n (%) | ||||
Male | 52 (74.3%) | 69 (67.6%) | 121 (70.3%) | 0.3490 |
Female | 18 (25.7%) | 33 (32.4%) | 51 (29.7%) | |
Age (years) | ||||
Mean (SD) | 70.20 (11.19) | 72.53 (9.81) | 71.58 (10.42) | 0.1505 |
Median | 73.00 | 73.50 | 73.00 | |
Range | 33.00–88.00 | 45.00–93.00 | 33.00–93.00 | |
Pooled geographic region n (%) | ||||
North America | 40 (57.1%) | 27 (26.5%) | 67 (39.0%) | 0.0001 |
Europe | 22 (31.4%) | 63 (61.8%) | 85 (49.4%) | |
Rest of the World | 8 (11.4%) | 12 (11.8%) | 20 (11.6%) | |
ECOG PS at baseline, n (%) | ||||
ECOG PS 0 | 38 (54.3%) | 66 (64.7%) | 104 (60.5%) | 0.1697 |
ECOG PS 1 | 32 (45.7%) | 36 (35.3%) | 68 (39.5%) | |
Site of primary tumor, n (%) | ||||
Non-skin | 9 (12.9%) | 7 (6.9%) | 16 (9.3%) | 0.1097 |
Skin | 55 (78.6%) | 91 (89.2%) | 146 (84.9%) | |
Not applicable | 0 (0.0%) | 4 (3.9%) | 4 (2.3%) | |
Missing | 6 (8.6%) | 0 (0.0%) | 6 (3.5%) | |
Tumor size at baseline (mm) | ||||
n (missing) | 61 (9) | 100 (2) | 161 (11) | |
Mean (SD) | 103.69 (79.68) | 79.46 (58.48) | 88.64 (68.09) | 0.0280 |
Median | 83.00 | 64.00 | 66.00 | |
Range | 16.00–404.00 | 0.00–288.00 | 0.00–404.00 | |
Time since initial diagnosis (years) | ||||
Mean (SD) | 2.19 (0.80) | 2.27 (0.76) | 2.24 (0.78) | 0.4631 |
Median | 2.00 | 2.00 | 2.00 | |
Min - Max | 1.00–3.00 | 1.00–3.00 | 1.00–3.00 | |
Time since first metastatic disease (months) | ||||
Mean (SD) | 16.94 (23.44) | 5.46 (7.66) | 10.13 (16.98) | <.0001 |
Median | 9.49 | 2.33 | 5.73 | |
Min - Max | 1.51–156.75 | 0.36–49.58 | 0.36–156.75 |