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Table 2 Common adverse events* and laboratory abnormalities in phase 2 patients treated with IL-21 (30 mcg/kg) plus sorafenib (starting at 400 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)  
Influenza-like illness 13 (39)
Headache 12 (36)
Nausea 12 (36) 2 (6)  
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)
  1. *Adverse events occurring in at least 30% of patients treated are included here.
  2. Includes any rash preferred term.
  3. §Laboratory abnormalities occurring in at least 50% of patients treated are included. Those occurring in <50% of patients included predominantly grade 1 or 2 electrolyte changes of no significant clinical consequence.