Table 2.
Treatment-emergent adverse events occurring in ≥10% of patients in either arm during the double-blind period (safety population).
| Sorafenib (n=207) | Placebo (n=209) | |||||
|---|---|---|---|---|---|---|
| Adverse event, n (%) | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 |
| Hand–foot skin reaction | 158 (76·3) | 42 (20·3) | – | 20 (9·6) | 0 | – |
| Diarrhoea | 142 (68·6) | 11 (5·3) | 1 (0·5) | 32 (15·3) | 2 (1·0) | 0 |
| Alopecia | 139 (67·1) | – | – | 16 (7·7) | – | – |
| Rash/desquamation | 104 (50·2) | 10 (4·8) | 0 | 24 (11·5) | 0 | 0 |
| Fatigue | 103 (49·8) | 11 (5·3) | 1 (0·5) | 53 (25·4) | 3 (1·4) | 0 |
| Weight loss | 97 (46·9) | 12 (5·8) | – | 29 (13·9) | 2 (1·0) | – |
| Hypertension | 84 (40·6) | 20 (9·7) | 0 | 26 (12·4) | 5 (2·4) | 0 |
| Anorexia | 66 (31·9) | 5 (2·4) | 0 | 10 (4·8) | 0 | 0 |
| Oral mucositis (functional/symptomatic) | 48 (23·2) | 1 (0·5) | 1 (0·5) | 7 (3·3) | 0 | 0 |
| Pruritus | 44 (21·3) | 2 (1·0) | – | 22 (10·5) | 0 | – |
| Nausea | 43 (20·8) | 0 | 0 | 24 (11·5) | 0 | 0 |
| Headache | 37 (17·9) | 0 | 0 | 15 (7·2) | 0 | 0 |
| Cough | 32 (15·5) | 0 | – | 32 (15·3) | 0 | - |
| Constipation | 31 (15·0) | 0 | 0 | 17 (8·1) | 1 (0·5) | 0 |
| Dyspnea | 30 (14.5) | 10 (4.8) | 0 | 28 (13.4) | 4 (1.9) | 2 (1.0) |
| Neuropathy: sensory | 30 (14.5) | 2 (1.0) | 0 | 13 (6.2) | 0 | 0 |
| Abdominal pain - not otherwise specified | 29 (14.0) | 3 (1.4) | 0 | 8 (3.8) | 1 (0.5) | 0 |
| Pain, extremity – limb | 28(13.5) | 1 (0.5) | 0 | 18 (8.6) | 1 (0.5) | 0 |
| Dermatology - Other | 27 (13.0) | 2 (1.0) | 0 | 5 (2.4) | 0 | 0 |
| Voice changes | 25 (12.1) | 1 (0.5) | 0 | 6 (2.9) | 0 | 0 |
| Fever | 23 (11.1) | 2 (1.0) | 1 (0.5) | 10 (4.8) | 0 | 0 |
| Vomiting | 23 (11.1) | 1 (0.5) | 0 | 12 (5.7) | 0 | 0 |
| Back pain | 22 (10.6) | 2 (1.0) | 0 | 22 (10.5) | 2 (1.0) | 1 (0.5) |
| Pain, other | 22 (10.6) | 1 (0.5) | 0 | 16 (7.7) | 1 (0.5) | 0 |
| Pain, throat/pharynx/larynx | 21 (10.1) | 0 | 0 | 8 (3.8) | 0 | 0 |
| Laboratory | ||||||
| Metabolic/laboratory – othera | 74 (35·7) | 0 | 0 | 35 (16·7) | 0 | 0 |
| Serum TSH increase (MedDRA) | 69 (33·3) | 0 | 0 | 28 (13·4) | 0 | 0 |
| Hypocalcaemia | 39 (18·8) | 12 (5·8) | 7 (3·4) | 10 (4·8) | 1 (0·5) | 2 (1·0) |
| ALT | 26 (12.6) | 5 (2.4) | 1 (0.5) | 9 (4.3) | 0 | 0 |
| AST | 23 (11.1) | 2 (1.0) | 0 | 5 (2.4) | 0 | 0 |
TSH, thyroid-stimulating hormone; MedDRA, Medical Dictionary for Regulatory Activities; NCI CTCAE, National Cancer Institute-Common Terminology Criteria for Adverse Events
a
TSH levels >0·5 mIU/L are included within this NCI CTCAE term and blood TSH increase (MedDRA v15·1 term) is also reported.
Adverse events reported using NCI CTCAE v3·0.