Table 3.
All-causalitv adverse events.
| Adverse event | Cabozantinib (N = 78) | Sunitinib (N = 72) | ||||
|---|---|---|---|---|---|---|
| Grade 1—2 | Grade 3 | Grade 4 | Grade 1—2 | Grade 3 | Grade 4 | |
| Any adverse event | 19 (24%) | 45 (58%) | 8 (10%) | 17 (24%) | 42 (58%) | 5 (7%) |
| Diarrhoeaa | 49 (63%) | 8 (10%) | 0 | 31 (43%) | 8 (11%) | 0 |
| AST increaseda | 45 (58%) | 1 (1%) | 1 (1%) | 20 (28%) | 2 (3%) | 0 |
| Fatiguea | 45 (58%) | 5 (6%) | 0 | 37 (51%) | 12 (17%) | 0 |
| ALT increaseda | 39 (50%) | 3 (4%) | 1 (1%) | 20 (28%) | 0 | 0 |
| Decreased appetite | 33 (42%) | 4 (5%) | 0 | 22 (31%) | 1 (1%) | 0 |
| Dysgeusia | 32 (41%) | 0 | 0 | 21 (29%) | 0 | 0 |
| Hypertensiona | 30 (39%) | 22 (28%) | 0 | 17 (24%) | 14 (19%) | 1 (1%) |
| Platelet count decreaseda | 29 (38%) | 1 (1%) | 0 | 36 (50%) | 6 (8%) | 2 (3%) |
| PPESa | 27 (35%) | 6 (8%) | 0 | 21 (29%) | 3 (4%) | 0 |
| Anaemia | 25 (32%) | 1 (1%) | 0 | 31 (43%) | 2 (3%) | 0 |
| Stomatitis | 25 (32%) | 4 (5%) | 0 | 17 (24%) | 4 (6%) | 0 |
| Nausea | 23 (29%) | 2 (3%) | 0 | 25 (35%) | 3 (4%) | 0 |
| Weight decreased | 22 (28%) | 3 (4%) | 0 | 12 (17%) | 0 | 0 |
| Dyspepsia | 21 (27%) | 0 | 0 | 12 (17%) | 0 | 0 |
| Hypothyroidism | 18 (23%) | 0 | 0 | 4 (6%) | 0 | 0 |
| Blood creatinine increased | 17 (22%) | 2 (3%) | 0 | 13 (18%) | 2 (3%) | 0 |
| Vomiting | 17 (22%) | 1 (1%) | 0 | 14 (19%) | 2 (3%) | 0 |
| Dizziness | 16 (21%) | 1 (1%) | 0 | 16 (22%) | 0 | 0 |
| Dysphonia | 16 (21%) | 1 (1%) | 0 | 1 (1%) | 1 (1%) | 0 |
| Hyperglycaemia | 16 (21%) | 0 | 0 | 7 (10% | 4 (6%) | 0 |
| Neutrophil count decreaseda | 12 (15%) | 0 | 0 | 22 (31%) | 3 (4%) | 0 |
| White blood cell count decreased | 9 (12%) | 0 | 0 | 23 (32%) | 2 (3%) | 0 |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; PPES, palmar-plantar erythrodysesthesia syndrome.
Treatment-emergent adverse events are summarised as of September 15, 2016. Adverse events that were reported as grade 1 or 2 in at least 20% of the patients in either study group are shown, irrespective of whether the event was considered by the investigator to be related to the study treatment. Some adverse events were solicited at every visit. For unsolicited adverse events, grade 1 or 2 events were only required to be reported if they were considered related by the investigator. Patients are counted once at the highest grade for each preferred term. The severity of adverse events was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Solicited adverse event.