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Table 3 TRAEs by Concomitant Mitotane Treatment (any grade in ≥10% of patients in either group or grade 3 in any patient)

From: Avelumab in patients with previously treated metastatic adrenocortical carcinoma: phase 1b results from the JAVELIN solid tumor trial

TRAE With Mitotane (n = 25) Without Mitotane (n = 25)
Any Grade Grade 3 Any Grade Grade 3
Any TRAE, n (%) 21 (84.0) 6 (24.0) 20 (80.0) 2 (8.0)
 Nausea 7 (28.0) 0 3 (12.0) 0
 Fatigue 5 (20.0) 0 4 (16.0) 0
 Pyrexia 5 (20.0) 0 2 (8.0) 0
 ALT increased 4 (16.0) 2 (8.0) 1 (4.0) 0
 AST increased 4 (16.0) 1 (4.0) 1 (4.0) 0
 Asthenia 3 (12.0) 0 1 (4.0) 0
 Back pain 3 (12.0) 0 0 0
 Chills 3 (12.0) 0 2 (8.0) 0
 Diarrhea 3 (12.0) 0 2 (8.0) 0
 Hypothyroidism 3 (12.0) 0 4 (16.0) 0
 Adrenal insufficiency 2 (8.0) 1 (4.0) 1 (4.0) 0
 GGT increase 2 (8.0) 1 (4.0) 0 0
 Vomiting 2 (8.0) 0 4 (16.0) 0
 Anemia 1 (4.0) 1 (4.0) 2 (8.0) 0
 Hypophosphatemia 1 (4.0) 0 2 (8.0) 1 (4.0)
 Infusion-related reaction 1 (4.0) 0 4 (16.0) 0
 Lymphopenia 1 (4.0) 1 (4.0) 0 0
 Transaminases increased 1 (4.0) 1 (4.0) 0 0
 Pneumonitis 0 0 2 (8.0) 1 (4.0)
  1. Abbreviations: ALT Alanine aminotransferase, AST Aspartate aminotransferase, GGT γ-glutamyltransferase
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