Table 3.

Safety overview

	Arm A (avelumab-chemotherapy) n = 41 n (%)		Arm B (chemotherapy alone) n = 43 n (%)
AEs of any cause	41 (100)		43 (100)
Grade 3/4 AE of any cause	40 (97.6)		34 (79.1)
Grade 3/4 treatment-related AE	29 (70.7)		31 (72.1)
Treatment-related SAE	9 (22)		6 (14)
Any AE leading to interruptions	14 (34.1)		22 (51.2)
Any AE leading to dose reduction	14 (34.1)		22 (51.2)

Treatment-emergent adverse event	All grades n (%)	G3-4 n (%)	All grades n (%)	G3-4 n (%)
Laboratory abnormalities
Anemia	25 (61)	11 (26.8)	32 (74.4)	20 (46.5)
Thrombocytopenia	11 (26.8)	9 (21.9)	10 (23.3)	6 (14)
Neutropenia	22 (53.7)	19 (46.4)	25 (58.1)	18 (41.9)
AST increased	5 (12.2)	1 (2.4)	1 (2.3)	0
Febrile neutropenia	2 (4.9)	2 (4.9)	6 (14)	6 (14)
Gastrointestinal disorders
Nausea	12 (29.3)	1 (2.4)	14 (32.6)	0
Diarrhea	11 (26.8)	0	11 (25.6)	1 (2.3)
Constipation	8 (19.5)	0	10 (23.3)	0
Vomiting	6 (14.6)	1 (2.4)	6 (14)	0
General disorders
Asthenia	22 (53.7)	5 (12.2)	29 (67.4)	2 (4.7)
Decreased appetite	11 (26.8)	0	12 (27.9)	0
Pyrexia	9 (22.0)	1 (2.4)	4 (9.3)	0
Fatigue	7 (17.1)	1 (2.4)	3 (7)	0
Peripheral edema	7 (17.1)	0	5 (11.6)	0
Infusion-related reaction	5 (12.2)	1 (2.4)	0	0
Arthralgia	5 (12.2)	0	2 (4.7)	0
Urinary symptoms
Hematuria	7 (17.1)	1 (2.4)	7 (16.3)	1 (2.3)
Urinary tract infection	6 (14.6)	3 (7.3)	11 (25.6)	5 (11.6)
Skin disorders
Pruritus	10 (24.4)	0	5 (11.6)	0
Rash	8 (19.5)	0	6 (14)	1 (2.3)

AEs that occurred in ≥10% of patients (with the exception of febrile neutropenia). AEs are presented according to descending order of frequency. As-treated population includes all patients who received one or more dose of trial therapy.

AE, adverse event; AST, aspartate aminotransferase; SAE, serious adverse event.