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Table 3 Incidence of treatment-related adverse events (TRAEs), infusion-related reactions (IRRs), and immune-related adverse events (irAEs)

From: Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial

  1 L (n = 62) 2 L (n = 20)
Any Grade Grade ≥ 3 Any Grade Grade ≥ 3
Any TRAE, n (%)a, b 51 (82.3) 8 (12.9) 14 (70.0) 1 (5.0)
 Pruritus 12 (19.4) 0 0 0
 Fatigue 11 (17.7) 0 5 (25.0) 1 (5.0)
 Asthenia 9 (14.5) 0 1 (5.0) 0
 Nausea 9 (14.5) 0 0 0
 Diarrhea 8 (12.9) 0 3 (15.0) 0
 Pyrexia 8 (12.9) 0 2 (10.0) 0
 Decreased appetite 6 (9.7) 0 2 (10.0) 0
 Increased lipase 6 (9.7) 4 (6.5) 1 (5.0) 0
 Rash 6 (9.7) 1 (1.6) 0 0
 Pneumonitis 2 (3.2) 0 2 (10.0) 0
 Anaphylactic reaction 1 (1.6) 1 (1.6) 0 0
 Colitis 1 (1.6) 1 (1.6) 0 0
 Thrombocytopenia 1 (1.6) 1 (1.6) 0 0
Infusion-related reactions, n (%)c, d 22 (35.5) 0 6 (30.0) 0
Any immune-related AE, n (%)c 18 (29.0) 2 (3.2) 3 (15.0) 0
 Hypothyroidism 7 (11.3) 0 1 (5.0) 0
 Rash 5 (8.1) 1 (1.6) 0 0
 Hyperthyroidism 3 (4.8) 0 0 0
 Pruritus 3 (4.8) 0 0 0
 Blood TSH increased 2 (3.2) 0 1 (5.0) 0
 Colitis 1 (1.6) 1 (1.6) 0 0
 Diarrhea 1 (1.6) 0 0 0
 Erythema 1 (1.6) 0 0 0
 Nephritis 1 (1.6) 0 0 0
 Pruritus generalized 1 (1.6) 0 0 0
 Psoriasis 1 (1.6) 0 0 0
 Rash generalized 1 (1.6) 0 0 0
 Rash macular 1 (1.6) 0 0 0
 Pneumonitis 0 0 1 (5.0) 0
 Rash pruritic 0 0 1 (5.0) 0
  1. a The incidence of treatment-related infusion-related reactions based on the single MedDRA preferred term is not listed
  2. b Any grade TRAEs in ≥ 10% patents and all grade 3 TRAEs
  3. c Composite term; includes AEs categorized as infusion-related reaction, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs/symptoms of infusion-related reaction (based on a prespecified list of MedDRA preferred terms) that occurred on the same day of infusion and resolved within 2 days
  4. d Includes AEs classified by investigators as related or unrelated to treatment
  5. 1 L first-line subgroup, 2 L second-line subgroup, AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, TRAE treatment-related adverse events, TSH thyroid-stimulating hormone