| Total n = 3202a (100) |
CP-A n = 1968 (61.5) |
CP-B n = 666 (20.8) |
||||
|---|---|---|---|---|---|---|
| All | DR | All | DR | All | DR | |
| AEs, %b | ||||||
| All grades | 85.3 | 66.0 | 84.0 | 68.5 | 88.6 | 64.4 |
| Grade 3/4 | 31.7 | 23.5 | 32.4 | 25.6 | 31.5 | 21.9 |
| SAEs | 43.3 | 9.3 | 36.0 | 8.8 | 60.4 | 14.1 |
| AE rate (event per patient-year)b | ||||||
| Any AE | 1.61 | 1.24 | 1.44 | 1.17 | 2.14 | 1.55 |
| Diarrhea | 0.58 | 0.51 | 0.54 | 0.48 | 0.71 | 0.62 |
| Hand-foot skin reaction | 0.51 | 0.50 | 0.55 | 0.54 | 0.42 | 0.41 |
| Fatigue | 0.45 | 0.29 | 0.38 | 0.27 | 0.62 | 0.34 |
| Discontinuation due to AEs, %b | 31.4 | 28.9 | 40.1 | |||
| Daily dose, median, mgd | 688.0 | 677.0 | 741.5 | |||
| Treatment duration, median, weeksd | 15.0 | 17.6 | 9.9 | |||
Includes CP-C, 74 pts; not evaluable, 493 pts
Treatment-emergent
Calculated based on 365.25 days per year
Pts with dosing data.