TABLE 2.
Patient demographics and baseline characteristics
| Characteristic | Efficacy population (n = 274) | Safety population (n = 573) |
|---|---|---|
| Categorical variables a | ||
| Sex | ||
| Female | 104 (38.0) | 197 (34.4) |
| Male | 170 (62.0) | 376 (65.6) |
| Race | ||
| White | 254 (95.5) | 511 (90.9) |
| Black/African American | 9 (3.4) | 24 (4.3) |
| Asian | 3 (1.1) | 6 (1.1) |
| Other | 0 (0) | 21 (3.7) |
| Ethnicity | ||
| Hispanic/Latino | 11 (4.0) | 19 (3.3) |
| Not Hispanic/Latino | 248 (90.5) | 520 (90.8) |
| Not reported | 15 (5.5) | 19 (3.3) |
| Unknown | 0 (0) | 15 (2.5) |
| ECOG performance status | ||
| 0 | 141 (51.5) | 253 (44.2) |
| 1 | 117 (42.7) | 293 (51.1) |
| 2 | 16 (5.8) | 25 (4.4) |
| 3 | 0 (0) | 2 (0.3) |
| Line of therapy | ||
| Treatment naïve | 274 (100) | 364 (63.5) |
| Relapsed/refractory | 0 (0) | 209 (36.5) |
| Chromosomal abnormality: 17p deletion | ||
| No | 250 (91.2) | 361 (86.8) |
| Yes | 24 (8.8) | 55 (13.2) |
| Chromosomal abnormality: 11q deletion | ||
| No | 220 (80.3) | 324 (77.7) |
| Yes | 54 (19.7) | 93 (22.3) |
| Continuous variables b | ||
| Age, y | 69.5 (7.8) | 66.9 (9.5) |
| Body weight, kg | 80.4 (18.4) | 81.1 (17.7) |
| SPD at baseline | 38.7 (50.9) | NA c |
| CD19+ cells, count | 3985 (15 152) | 18 160 (45 420) |
| Absolute neutrophil count, 109/L | 11.3 (15.4) | 7.6 (11.4) |
| Haemoglobin, g/L | 117 (20.0) | 116.0 (20.9) |
| Thrombocyte count, 109/L | 147 (67.0) | 150 (81.1) |
CD19+, cluster of differentiation 19 expressing B‐cells; ECOG, Eastern Cooperative Oncology Group; SPD, sum of the products of the greatest diameters.
a
Values are n (%).
b
Values are mean (standard deviation).
c
Not relevant for the safety population.