Neutropenia by Maximum Toxicity Grade Across Phase 3 Trials (n, %)
| Neutrophil count decreased | 0–18 wks | Long-term analysis | |||
|---|---|---|---|---|---|
| Neutrophil count decreased | Pbo (N=850) | SIR 50mg q4w (N=848) | SIR 100mg q2w (N=850) | SIR 50mg q4w (N=1454) | SIR 100mg q2w (N=1461) |
| Grade 0 (≥LLN) | 816 (96.9) | 576 (68.3) | 568 (67.1) | 843 (58.0) | 806 (55.2) |
| Grade 1 (3) | 19 (2.3) | 149 (17.7) | 167 (19.7) | 313 (21.5) | 352 (24.1) |
| Grade 2 (<1,500–1,000/mm3) | 5 (0.6) | 97 (11.5) | 94 (11.1) | 222 (15.3) | 240 (16.4) |
| Grade 3 (<1,000–500/mm3) | 1 (0.1) | 21 (2.5) | 16 (1.9) | 68 (4.7) | 61 (4.2) |
| Grade 4 (<500/mm3) | 1 (0.1) | 0 | 1 (0.1) | 8 (0.6) | 2 (0.1) |
LLN, lower limit of normal.