Table 3.
Patients (%) with treatment-emergent adverse events, regardless of causality, that occurred in ≥30% of patients
| TEAE | All patients |
EKB25, CAPE750 |
EKB50, CAPE750 |
EKB50, CAPE1000 |
EKB75, CAPE1000 |
|---|---|---|---|---|---|
| N = 37 | n = 6 | n = 7 | n = 20 | n = 4 | |
| Diarrhea | |||||
| Grade 1–4 | 32 (86) | 5 | 5 | 18 (90) | 4 |
| Grade 3–4 | 8 (22) | 1 | 5 | 1 (5) | 1 |
| Nausea | |||||
| Grade 1–4 | 27 (73) | 6 | 4 | 15 (75) | 2 |
| Grade 3–4 | 2 (5) | 2 | 0 | 0 | 0 |
| Asthenia | |||||
| Grade 1–4 | 25 (68) | 5 | 3 | 14 (70) | 3 |
| Grade 3–4 | 1 (3) | 0 | 1 | 0 | 0 |
| Anorexia | |||||
| Grade 1–4 | 22 (59) | 4 | 2 | 13 (65) | 3 |
| Grade 3–4 | 1 (3) | 1 | 0 | 0 | 0 |
| Abdominal pain | |||||
| Grade 1–4 | 21 (57) | 5 | 4 | 10 (50) | 2 |
| Grade 3–4 | 3 (8) | 2 | 1 | 0 | 0 |
| Rash | |||||
| Grade 1–2 | 18 (49) | 3 | 4 | 10 (50) | 1 |
| Vomiting | |||||
| Grade 1–4 | 17 (46) | 2 | 2 | 12 (60) | 1 |
| Grade 3–4 | 3 (8) | 2 | 1 | 0 | 0 |
| Skin disorder | |||||
| Grade 1–4 | 16 (43) | 2 | 3 | 10 (50) | 1 |
| Grade 3–4 | 1 | 1 | 0 | 0 | 0 |
| Stomatitis | |||||
| Grade 1–2 | 13 (35) | 2 | 1 | 10 (50) | 0 |
| Fever | |||||
| Grade 1–4 | 11 (30) | 2 | 0 | 8 (40) | 1 |
| Grade 3–4 | 1 (3) | 0 | 1 | 0 | 0 |
| Pain | |||||
| Grade 1–4 | 11 (30) | 2 | 3 | 5 (25) | 1 |
Abbreviations: EKB25, CAPE750, EKB-569 25 mg and capecitabine 750 mg/m2; EKB50, CAPE750, EKB-569 50 mg and capecitabine 750 mg/m2; EKB50, CAPE1000, EKB-569 50 mg and capecitabine 1,000 mg/m2; EKB75, CAPE1000, EKB-569 75 mg and capecitabine 1,000 mg/m2; TEAE, treatment-emergent adverse event.