Table 1 Demographics and patient characteristics—historical comparator and clinical trial data
Historical data set | Clinical trial data | ||
---|---|---|---|
Patients with CR data | Patients with OS data | Blinatumomab trial (MT103-211) | |
N=694 | N=1112 | N=189a | |
Sex, n (%) | |||
Male | 421 (60.7) | 644 (57.9) | 119 (63%) |
Female | 273 (39.3) | 468 (42.1) | 70 (37%) |
Mean (s.d.) age, years | 38.8 (14.8) | 37.4 (14.2) | 41.1 (17.3) |
Age group (years) | |||
18–34 | 317 (45.6) | 527 (47.4) | 90 (48) |
35–54 | 256 (36.9) | 428 (38.5) | 46 (24) |
⩾55 | 80 (11.5) | 115 (10.3) | 53 (28) |
⩾65 | 41 (5.9) | 42 (3.8) | 25 (13) |
Disease status, n (%) | |||
Primary refractory | 16 (8.5) | ||
In 1st salvage | 61 (8.8) | 56 (5.0) | 4 (2.1) |
In 2nd or greater salvage | 50 (7.2) | 61 (5.5) | 12 (6.3) |
Relapsed, with prior alloHSCT | 64 (33.9) | ||
In 1st salvage | 44 (6.3) | 130 (11.7) | 9 (4.8) |
In 2nd or greater salvage | 45 (6.5) | 57 (5.1) | 55 (29.1) |
Relapsed, without prior alloHSCT | 109 (57.7) | ||
In 1st salvage | 245 (35.3) | 543 (48.8) | 25 (13.2) |
In 2nd or greater salvage | 249 (35.9) | 265 (23.8) | 84 (44.4) |
Year of initial diagnosis, n (%) | |||
1990 to 1999 | 246 (35.4) | 364 (32.7) | 0 (0) |
2000 or later | 448 (64.6) | 748 (67.3) | 189 (100) |
Region, n (%) | |||
Europe | 393 (56.6) | 811 (72.9) | 95 (50) |
USA | 301 (43.4) | 301 (27.1) | 94 (50) |