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)
TRAE	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)

Abbreviations: ALT Alanine aminotransferase, AST Aspartate aminotransferase, GGT γ-glutamyltransferase

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