Table 2 Common adverse events* and laboratory abnormalities in phase 2 patients treated with IL-21 (30 mcg/kg) plus sorafenib (starting at 400Â mg twice daily)
From: Recombinant interleukin-21 plus sorafenib for metastatic renal cell carcinoma: a phase 1/2 study
Adverse event preferred term* [N = 33 unless noted] | Any grade n (%) | Grade 3 n (%) | Grade 4 n (%) |
|---|---|---|---|
Rash†| 31 (94) | 9 (29) | — |
Fatigue | 23 (70) | 2 (6) | 1 (3) |
Diarrhea | 20 (61) | 2 (6) | — |
Pyrexia | 20 (61) | — | — |
Chills | 18 (55) | — | — |
Palmar-plantar erythrodysaesthesia (hand-foot syndrome) | 18 (55) | 8 (24) | — |
Alopecia | 15 (45) | — | — |
Vomiting | 14 (42) | 2 (6) | Â |
Influenza-like illness | 13 (39) | — | — |
Headache | 12 (36) | — | — |
Nausea | 12 (36) | 2 (6) | Â |
Pruritus | 12 (36) | — | — |
Arthralgia | 10 (30) | — | — |
Pain in extremity | 10 (30) | 1 (3) | — |
Laboratory abnormality § | Any grade | Grade 3 n (%) | Grade 4 n (%) |
Lymphopenia | 32 (97) | 16 (48) | 7 (21) |
Hypophosphatemia | 27 (82) | 17 (52) | 2 (6) |
Lipase high (n = 31) | 16 (52) | 7 (23) | 1 (3) |
Hyponatremia (n = 22) | 22 (100) | 5 (23) | — |
Platelets low | 27 (82) | 6 (18) | 1 (3) |
Hyperuricemia (n = 32) | 16 (50) | — | 7 (22) |
Platelets low | 27 (82) | 6 (18) | 1 (3) |
AST high | 22 (67) | 6 (18) | — |
ALT high | 22 (67) | 5 (15) | — |
Leukocytes low | 20 (61) | 4 (12) | — |
Neutrophils low | 18 (55) | 1 (3) | 3 (9) |
Hypokalemia (n = 9) | 9 (100) | 1 (11) | — |