Table 3.
Common treatment‐emergent adverse events in patients with CNS metastases at baseline (occurring in ≥10 patients)
| Adverse event | N + C (n = 50) | L + C (n = 49) | ||
|---|---|---|---|---|
| Grade 1–4 | Grade 3/4 | Grade 1–4 | Grade 3/4 | |
| Any event | 50 (100) | 30 (60.0) | 48 (98.0) | 30 (61.2) |
| Diarrhea | 41 (82.0) | 11 (22.0) | 33 (67.3) | 5 (10.2) |
| Nausea | 28 (56.0) | 2 (4.0) | 19 (38.8) | 3 (6.1) |
| Vomiting | 25 (50.0) | 1 (2.0) | 16 (32.7) | 1 (2.0) |
| Palmar‐plantar erythrodysesthesia syndrome | 23 (46.0) | 6 (12.0) | 22 (44.9) | 6 (12.2) |
| Constipation | 19 (38.0) | 0 (0.0) | 8 (16.3) | 0 (0.0) |
| Fatigue | 19 (38.0) | 2 (4.0) | 18 (36.7) | 2 (4.1) |
| Decreased appetite | 18 (36.0) | 1 (2.0) | 11 (22.4) | 1 (2.0) |
| Weight decreased | 17 (34.0) | 1 (2.0) | 9 (18.4) | 1 (2.0) |
| Stomatitis | 11 (22.0) | 0 (0.0) | 14 (28.6) | 1 (2.0) |
| Aspartate aminotransferase increased | 9 (18.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) |
| Dizziness | 9 (18.0) | 1 (2.0) | 8 (16.3) | 0 (0.0) |
| Headache | 9 (18.0) | 0 (0.0) | 14 (28.6) | 0 (0.0) |
| Hypokalemia | 9 (18.0) | 4 (8.0) | 8 (16.3) | 3 (6.1) |
| Paronychia | 9 (18.0) | 1 (2.0) | 11 (22.4) | 0 (0.0) |
| Abdominal pain | 7 (14.0) | 0 (0.0) | 8 (16.3) | 1 (2.0) |
| Anemia | 7 (14.0) | 0 (0.0) | 9 (18.4) | 1 (2.0) |
| Pyrexia | 4 (8.0) | 0 (0.0) | 7 (14.3) | 1 (2.0) |
| Rash | 4 (8.0) | 0 (0.0) | 17 (34.7) | 1 (2.0) |
| Back pain | 4 (8.0) | 0 (0.0) | 7 (14.3) | 0 (0.0) |
| Asthenia | 3 (6.0) | 1 (2.0) | 9 (18.4) | 3 (6.1) |
Data presented as n (%).
Abbreviations: CNS, central nervous system; L + C, lapatinib plus capecitabine; N + C, neratinib plus capecitabine.