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Table 2 TRAEs (in ≥30% of patients), select TRAEs, and TRAEs leading to discontinuation in ≥2 patients

From: Safety and efficacy of nivolumab in combination with sunitinib or pazopanib in advanced or metastatic renal cell carcinoma: the CheckMate 016 study

TRAE, preferred term, n (%)a Treatment arm
N + S (N = 33) N + P (N = 20)
All grades Grade 3 or 4 All grades Grade 3 or 4
Total patients with an event 33 (100.0) 27 (81.8) 20 (100.0) 14 (70.0)
 Fatigue 28 (84.8) 3 (9.1) 12 (60.0) 3 (15.0)
 Diarrhea 21 (63.6) 3 (9.1) 12 (60.0) 4 (20.0)
 Dysgeusia 21 (63.6) 0 10 (50.0) 0
 Nausea 19 (57.6) 1 (3.0) 15 (75.0) 0
 Hypertension 16 (48.5) 6 (18.2) 5 (25.0) 2 (10.0)
 Decreased appetite 16 (48.5) 1 (3.0) 8 (40.0) 0
 Increased ALT 13 (39.4) 6 (18.2) 5 (25.0) 4 (20.0)
 Palmar-plantar erythrodysesthesia syndrome 13 (39.4) 0 0 0
 Increased AST 12 (36.4) 3 (9.1) 6 (30.0) 4 (20.0)
 Blood creatinine increased 11 (33.3) 2 (6.1) 1 (5.0) 0
 Hypothyroidism 11 (33.3) 0 4 (20.0) 1 (5.0)
 Dyspepsia 11 (33.3) 0 4 (20.0) 0
 Dry skin 11 (33.3) 0 2 (10.0) 0
 Mucosal inflammation 10 (30.3) 0 5 (25.0) 0
 Dry mouth 10 (30.3) 0 1 (5.0) 0
 Arthralgia 8 (24.2) 0 7 (35.0) 1 (5.0)
 Pruritus 8 (24.2) 0 7 (35.0) 0
 Vomiting 7 (21.2) 1 (3.0) 6 (30.0) 0
Select TRAE, organ class, n (%)b
 Skin 26 (78.8) 2 (6.1) 11 (55.0) 0
 Endocrine 12 (36.4) 0 5 (25.0) 2 (10.0)
 Gastrointestinal 21 (63.6) 3 (9.1) 12 (60.0) 4 (20.0)
 Hepatic 15 (45.5) 8 (24.2) 7 (35.0) 4 (20.0)
 Renal 13 (39.4) 4 (12.1) 1 (5.0) 0
 Pulmonary 1 (3.0) 1 (3.0) 1 (5.0) 0
TRAE leading to discontinuation, preferred term, n (%)a
 Total patients with an event 13 (39.4) 11 (33.3) 5 (25.0) 4 (20.0)
  Increased ALT 3 (9.1) 2 (6.1) 3 (15.0) 3 (15.0)
  Acute kidney injury 3 (9.1) 1 (3.0) 0 0
  Increased AST 1 (3.0) 1 (3.0) 3 (15.0) 3 (15.0)
  1. aIncludes events reported between the first dose and 100 days after the last dose of study therapy
  2. bIncludes events reported between the first dose and 30 days after the last dose of study therapy