Table 2.
Adverse events occurring in ≥15% of patients with advanced TRK fusion-positive thyroid carcinoma treated with larotrectinib.
| Preferred term | Treatment-emergent AEs, n (%) | Treatment-related AEs, n (%) | |||||
|---|---|---|---|---|---|---|---|
| Grade 1 or 2 | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 | Any grade | |
| Myalgia | 12 (41) | 0 | 0 | 12 (41) | 0 | 0 | 8 (28) |
| Fatigue | 10 (34) | 0 | 0 | 10 (34) | 0 | 0 | 8 (28) |
| Nausea | 10 (34) | 0 | 0 | 10 (34) | 0 | 0 | 3 (10) |
| Constipation | 9 (31) | 0 | 0 | 9 (31) | 0 | 0 | 5 (17) |
| Cough | 8 (28) | 1 (3) | 0 | 9 (31) | – | – | – |
| Dizziness | 8 (28) | 1 (3) | 0 | 9 (31) | 0 | 0 | 8 (28) |
| Peripheral oedema | 9 (31) | 0 | 0 | 9 (31) | 0 | 0 | 4 (14) |
| ALT increased | 8 (28) | 0 | 0 | 8 (28) | 0 | 0 | 8 (28) |
| Anaemia | 4 (14) | 4 (14) | 0 | 8 (28) | 1 (3) | 0 | 2 (7) |
| AST increased | 8 (28) | 0 | 0 | 8 (28) | 0 | 0 | 8 (28) |
| Arthralgia | 7 (24) | 0 | 0 | 7 (24) | 0 | 0 | 3 (10) |
| Diarrhoea | 4 (14) | 3 (10) | 0 | 7 (24) | 0 | 0 | 3 (10) |
| Dyspnoea | 6 (21) | 1 (3) | 0 | 7 (24) | 0 | 0 | 1 (3) |
| Leukocyte count decreased | 6 (21) | 1 (3) | 0 | 7 (24) | 0 | 0 | 6 (21) |
| Lymphocyte count decreased | 3 (10) | 3 (10) | 1 (3) | 7 (24) | 1 (3) | 0 | 2 (7) |
| Vomiting | 7 (24) | 0 | 0 | 7 (24) | 0 | 0 | 2 (7) |
| Headache | 6 (21) | 0 | 0 | 6 (21) | 0 | 0 | 1 (3) |
| Pyrexia | 6 (21) | 0 | 0 | 6 (21) | 0 | 0 | 1 (3) |
| Hypoaesthesia | 5 (17) | 0 | 0 | 5 (17) | 0 | 0 | 3 (10) |
| Hypocalcaemia | 2 (7) | 2 (7) | 1 (3) | 5 (17) | 0 | 0 | 1 (3) |
| Nasal congestion | 5 (17) | 0 | 0 | 5 (17) | 0 | 0 | 1 (3) |
| Pain in extremity | 5 (17) | 0 | 0 | 5 (17) | 0 | 0 | 2 (7) |
| Rash | 5 (17) | 0 | 0 | 5 (17) | 0 | 0 | 3 (10) |
Dashes indicate AEs that were not reported to be treatment-related in any patients.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TRK, tropomyosin receptor kinase.
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