TABLE 2.
Adverse Events Reported With an Attribution of Being Possibly, Probably, or Definitely Related to Protocol Treatment and Occurring in 10% or More of Patients in the Sunitinib or Cabozantinib Arms
| Adverse Event | Cabozantinib (n = 43), No. (%) | Sunitinib (n = 45), No. (%) | ||
|---|---|---|---|---|
| Grade 3-4 | Any grade | Grade 3-4 | Any grade | |
| Maximum grade any adverse event | 29 (67) | 42 (98) | 31 (69) | 43 (96) |
| Nonhematologic adverse events | ||||
| Abdominal pain | 3 (7) | 6 (14) | 1 (2) | 3 (7) |
| Constipation | 0 (0) | 8 (19) | 0 (0) | 5 (11) |
| Diarrhea | 3 (7) | 24 (56) | 3 (7) | 22 (49) |
| Dry mouth | 0 (0) | 6 (14) | 0 (0) | 5 (11) |
| Dysgeusia | 0 (0) | 18 (42) | 0 (0) | 14 (31) |
| Dyspepsia | 0 (0) | 3 (7) | 0 (0) | 5 (11) |
| Mucositis oral | 1 (2) | 16 (37) | 0 (0) | 13 (29) |
| Nausea | 0 (0) | 16 (37) | 4 (9) | 20 (44) |
| Vomiting | 0 (0) | 6 (14) | 1 (2) | 11 (24) |
| GI disorders—others | 1 (2) | 6 (14) | 0 (0) | 3 (7) |
| Hand-foot syndrome | 9 (21) | 21 (49) | 0 (0) | 11 (24) |
| Headache | 0 (0) | 5 (12) | 0 (0) | 4 (9) |
| Fatigue | 6 (14) | 30 (70) | 4 (9) | 28 (62) |
| Dyspnea | 0 (0) | 6 (14) | 0 (0) | 3 (7) |
| Dizziness | 0 (0) | 1 (2) | 0 (0) | 5 (11) |
| Thromboembolic event | 5 (12) | 8 (19) | 0 (0) | 1 (2) |
| Pain in extremity | 1 (2) | 7 (16) | 0 (0) | 3 (7) |
| Peripheral sensory neuropathy | 0 (0) | 6 (14) | 0 (0) | 0 (0) |
| Dehydration | 0 (0) | 1 (2) | 1 (2) | 5 (11) |
| Hoarseness | 0 (0) | 7 (16) | 0 (0) | 2 (4) |
| Hyperthyroidism | 0 (0) | 7 (16) | 0 (0) | 2 (4) |
| Hypothyroidism | 0 (0) | 17 (40) | 0 (0) | 9 (20) |
| Skin/subcutaneous tissue | 0 (0) | 5 (12) | 0 (0) | 8 (18) |
| Rash acneiform | 0 (0) | 5 (12) | 0 (0) | 0 (0) |
| Rash maculopapular | 0 (0) | 9 (21) | 0 (0) | 3 (7) |
| Hematologic adverse events | ||||
| WBC decreased | 0 (0) | 9 (21) | 5 (11) | 13 (29) |
| Neutrophil count decreased | 0 (0) | 7 (16) | 4 (9) | 11 (24) |
| Lymphocyte count decreased | 0 (0) | 6 (14) | 2 (4) | 10 (22) |
| Anemia | 0 (0) | 11 (26) | 6 (13) | 17 (38) |
| Platelet count decreased | 0 (0) | 9 (21) | 2 (4) | 19 (42) |
| Laboratory adverse events | ||||
| ALT increased | 1 (2) | 13 (30) | 1 (2) | 6 (13) |
| AST increased | 0 (0) | 15 (35) | 1 (2) | 8 (18) |
| Creatinine increased | 0 (0) | 7 (16) | 0 (0) | 14 (31) |
| Hypoalbuminemia | 0 (0) | 7 (16) | 1 (2) | 6 (13) |
| Hypocalcemia | 1 (2) | 11 (26) | 0 (0) | 1 (2) |
| Hypokalemia | 0 (0) | 6 (14) | 0 (0) | 0 (0) |
| Hypomagnesemia | 2 (5) | 10 (23) | 0 (0) | 0 (0) |
| Hyponatremia | 3 (7) | 3 (7) | 2 (4) | 5 (11) |
| Hypophosphatemia | 6 (14) | 13 (30) | 0 (0) | 3 (7) |
| Proteinuria | 2 (5) | 9 (21) | 1 (2) | 8 (18) |