Table 3.
TEAEs reported in ≥ 10% of Asian patients in the safety population
| AE—n (%) | N+C (n = 104) | L+C (n = 98) | ||
|---|---|---|---|---|
| All grade | Grade 3/4 | All grade | Grade 3/4 | |
| Diarrhea | 82 (78.8) | 26 (25.0) | 50 (51.0) | 6 (6.1) |
| Palmar-plantar erythrodysaesthesia | 53(51.0) | 12 (11.5) | 67 (68.4) | 9 (9.2) |
| Vomiting | 49 (47.1) | 4 (3.8) | 21 (21.4) | 0 (0.0) |
| Decreased appetite | 42 (40.4) | 2 (1.9) | 18 (18.4) | 3 (3.1) |
| Nausea | 42 (40.4) | 1 (1.0) | 28 (28.6) | 1 (1.0) |
| Fatigue | 29 (27.9) | 0 (0.0) | 24 (24.5) | 1 (1.0) |
| Constipation | 25 (24.0) | 1 (1.0) | 11 (11.2) | 1 (1.0) |
| Weight decreased | 25 (24.0) | 1 (1.0) | 14 (14.3) | 1 (1.0) |
| Stomatitis | 23 (22.1) | 2 (1.9) | 28 (28.6) | 4 (4.1) |
| Paronychia | 17 (16.3) | 2 (1.9) | 25 (25.5) | 1 (1.0) |
| Dizziness | 15 (14.4) | 0 (0.0) | 14 (14.3) | 1 (1.0) |
| Cough | 14 (13.5) | 0 (0.0) | 13 (13.3) | 0 (0.0) |
| Anemia | 13 (12.5) | 2 (1.9) | 16 (16.3) | 5 (5.1) |
| Pruritus | 13 (12.5) | 0 (0.0) | 11 (11.2) | 0 (0.0) |
| Upper respiratory tract infection | 13 (12.5) | 0 (0.0) | 7(7.1) | 0 (0.0) |
| Abdominal distension | 11 (10.6) | 0 (0.0) | 6 (6.1) | 2 (2.0) |
| Pyrexia | 11 (10.6) | 0 (0.0) | 10 (10.2) | 1 (1.0) |
| Headache | 10 (9.6) | 1 (1.0) | 14 (14.3) | 3 (3.1) |
| Rash | 9 (8.7) | 0 (0.0) | 22 (22.4) | 2 (2.0) |
| Hypokalaemia | 8 (7.7) | 3 (2.9) | 13 (13.3) | 6 (6.1) |
| Dermatitis acneiform | 7 (6.7) | 0 (0.0) | 11 (11.2) | 0 (0.0) |
AEs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
A treatment emergent adverse event (TEAE) was defined as any AE that occurred or worsened on or after the first dose of study drug and up to 28 days following the last dose
AEs adverse events, L+C lapatinib+capecitabine, N+C neratinib+capecitabine