Table 2 Treatment-related toxicities and adverse events.
A. Treatment-related toxicities | ||
Events, Total (# patients) | HER2− (n = 19)a | HER2+ (n = 6) |
AEs | 104 (15) | 42 (6) |
SAEs | 17 (7) | 0 (0) |
Grade 3 AEs | 15 (6) | 1 (1) |
Grade 4 AEs | 0 (0) | 0 (0) |
B. Treatment-related AEs in 2 or more patients | ||
AE, Any Grade, n (%) | HER2− (n = 19)a | HER2+ (n = 6) |
Colitis | 6 (32) | 0 |
Diarrhea | 6 (32) | 0 |
Fatigue | 6 (32) | 3 (50) |
Nausea | 6 (32) | 3 (50) |
Anorexia | 6 (32) | 1 (17) |
Vomiting | 3 (16) | 3 (50) |
Weight loss | 3 (16) | 2 (33) |
Rash, maculo-papular | 3 (16) | 1 (17) |
Mucositis oral | 1 (6) | 3 (50) |
Generalized muscle weakness | 3 (16) | 0 |
Abdominal pain | 2 (11) | 1 (17) |
Dry mouth | 2 (11) | 1 (17) |
Dysgeusia | 2 (11) | 1 (17) |
Hypothyroidism | 2 (11) | 0 |
Headache | 2 (11) | 0 |
Alkaline phosphatase increased | 2 (11) | 0 |
Skin Hyperpigmentation | 0 | 2 (33) |
Constipation | 1 (6) | 1 (17) |
Hyperthyroidism | 1 (6) | 1 (17) |
Alopecia | 1 (6) | 1 (17) |
Dry skin | 1 (6) | 1 (17) |
Decreased T3, Free | 1 (6) | 1 (17) |
Pruritus | 1 (6) | 1 (17) |
AE, Grade 3, n (%) | ||
Colitis | 3 (16) | 0 |
Diarrhea | 2 (11) | 0 |
Rash maculo-papular | 1 (6) | 1 (17) |
