Table 3.
Subgroup analysis 1: number of relapses by ALC count (safety population)
| No. of patients with relapse, n (%) | Without lymphopenia (ALC remained ≥ LLN) | With lymphopenia (at least one ALC < LLN) | ||||
|---|---|---|---|---|---|---|
| Baseline n = 593 |
Week 48 n = 593 |
Week 96 n = 593 |
Baseline n = 452 |
Week 48 n = 452 |
Week 96 n = 452 |
|
| 0 | 251 (42.3) | 524 (88.4) | 494 (83.3) | 207 (45.8) | 398 (88.1) | 375 (83.0) |
| 1 | 259 (43.7) | 60 (10.1) | 76 (12.8) | 190 (42.0) | 49 (10.8) | 56 (12.4) |
| 2 | 73 (12.3) | 8 (1.3) | 16 (2.7) | 49 (10.8) | 5 (1.1) | 18 (4.0) |
| 3 | 6 (1.0) | 0 | 5 (0.8) | 4 (0.9) | 0 | 3 (0.7) |
| ≥ 4 | 4 (0.7) | 1 (0.2) | 2 (0.3) | 2 (0.4) | 0 | 0 |
Baseline: 12 months prior to study entry
ALC absolute lymphocyte count, LLN lower limit of normal