Table 2.
Adverse events possibly, probably or definitively related to tivozanib (n, %).
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fatigue | 6 | 22 | 4 | 15 | 7 | 26 | 0 | 0 | 0 | 0 | 17 | 63 |
| Diarrhoea | 6 | 22 | 5 | 19 | 0 | 0 | 0 | 0 | 0 | 0 | 11 | 41 |
| Decreased appetite | 3 | 11 | 6 | 22 | 1 | 4 | 0 | 0 | 0 | 0 | 10 | 37 |
| Nausea | 4 | 15 | 3 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 26 |
| Dysphonia | 6 | 22 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 26 |
| Vomiting | 4 | 15 | 2 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 22 |
| Stomatitis | 4 | 15 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 19 |
| Elevated bilirubin | 0 | 0 | 3 | 11 | 2 | 7 | 0 | 0 | 0 | 0 | 5 | 18 |
| Hypertension | 1 | 4 | 1 | 4 | 2 | 7 | 1 | 4 | 0 | 0 | 5 | 19 |
| Thrombocytopenia | 4 | 15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 15 |
| Increased ALP | 0 | 0 | 0 | 0 | 3 | 11 | 0 | 0 | 0 | 0 | 3 | 11 |
| Lymphocytopenia | 1 | 4 | 1 | 4 | 1 | 4 | 0 | 0 | 0 | 0 | 3 | 12 |
| Epistaxis | 3 | 11 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 11 |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 3 | 11 | 0 | 0 | 0 | 0 | 3 | 11 |
| PPEDS | 2 | 7 | 0 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 3 | 11 |
| Increased ALT | 1 | 4 | 0 | 0 | 1 | 4 | 0 | 0 | 0 | 0 | 2 | 8 |
| Decreased weight | 0 | 0 | 1 | 4 | 1 | 4 | 0 | 0 | 0 | 0 | 2 | 8 |
| Dizziness | 2 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7 |
| Headache | 2 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 |
| Dry skin | 1 | 4 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 7 |
| Pruritus | 1 | 4 | 1 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 8 |
ALP alkaline phosphatase, ALT alanine aminotransferase, PPEDS palmar–plantar erythrodysesthesia syndrome.