Table 6.
Adverse events reported in at least 30% of patients in either treatment arm of the METEOR study.
| Adverse event | Cabozantinib (n = 331) |
Everolimus (n = 322) |
||
|---|---|---|---|---|
| Any grade, n (%) | Grade 3 or 4, n (%) | Any grade, n (%) | Grade 3 or 4, n (%) | |
| Any adverse event | 305 (92) | 235 (71) | 296 (89) | 193 (58) |
| Diarrhoea | 249 (75) | 43 (13) | 92 (29) | 7 (2) |
| Fatigue | 195 (59) | 36 (11) | 154 (48) | 24 (7) |
| Nausea | 173 (52) | 15 (5) | 93 (29) | 1 (<1) |
| Decreased appetite | 156 (47) | 10 (3) | 114 (35) | 3 (1) |
| Hand–foot syndrome | 142 (43) | 27 (8) | 19 (6) | 3 (1) |
| Vomiting | 113 (34) | 7 (2) | 47 (15) | 3 (1) |
| Weight decreased | 114 (34) | 9 (3) | 42 (13) | 0 (0) |
| Hypertension | 122 (37) | 49 (15) | 26 (8) | 12 (4) |
| Cough | 68 (21) | 1 (<1) | 110 (34) | 3 (1) |
| Rash | 54 (16) | 2 (1) | 94 (29) | 2 (1) |
| Anaemia | 61 (18) | 19 (6) | 126 (39) | 53 (16) |
Events reported irrespective of whether the event was considered by the investigator to be related to the study treatment. One treatment-related death occurred in the cabozantinib group (death not otherwise specified) and two occurred in the everolimus group (one aspergillus infection and one pneumonia aspiration). The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
Adapted from Choueiri et al.34