Table 2.
Summary of most common AEs (all-causality) reported in >10% patients in any treatment group: as-treated population
| AE, n (%) | Axitinib (n = 356) | Placebo (n = 359) |
|---|---|---|
| Hypertension | 229 (64) | 88 (25) |
| Diarrhea | 169 (47) | 51 (14) |
| Dysphonia | 150 (42) | 21 (6) |
| Hand-foot syndrome | 115 (32) | 17 (5) |
| Proteinuria | 83 (23) | 24 (7) |
| Fatigue | 75 (21) | 42 (12) |
| Hypothyroidisma | 73 (21) | 19 (5) |
| Arthralgia | 58 (16) | 36 (10) |
| Nasopharyngitis | 57 (16) | 63 (18) |
| Headache | 47 (13) | 41 (11) |
| Increased blood TSHa | 47 (13) | 5 (1) |
| Rash | 46 (13) | 15 (4) |
| Stomatitis | 46 (13) | 9 (3) |
| Back pain | 45 (13) | 54 (15) |
| Decreased appetite | 44 (12) | 7 (2) |
| Asthenia | 41 (12) | 22 (6) |
| Dizziness | 41 (12) | 34 (10) |
a
Not all patients with an AE of increased blood TSH had a clear diagnosis of hypothyroidism, i.e. presenting other clinical signs.
AE, adverse event; TSH, thyroid-stimulating hormone.