Table 5.

Adverse events of any cause with an incidence of ≥ 15% in either arm and all grade 3 or 4 events

	Durvalumab + EP (n = 18)		EP (n = 16)
	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4
Any event, n (%)	18 (100)	14 (78)	16 (100)	15 (94)
Constipation	13 (72)	0	7 (44)	0
Nausea	8 (44)	0	10 (63)	1 (6)
Neutropenia	6 (33)	6 (33)	7 (44)	7 (44)
Alopecia	6 (33)	0	6 (38)	0
Anemia	4 (22)	1 (6)	6 (38)	2 (13)
Hiccups	5 (28)	0	5 (31)	0
Neutrophil count decreased	5 (28)	4 (22)	5 (31)	3 (19)
Decreased appetite	6 (33)	2 (11)	3 (19)	1 (6)
Febrile neutropenia	6 (33)	6 (33)	3 (19)	3 (19)
Insomnia	4 (22)	0	4 (25)	0
White blood cell count decreased	2 (11)	1 (6)	6 (38)	4 (25)
Dry skin	3 (17)	0	3 (19)	0
Malaise	4 (22)	0	2 (13)	0
Pyrexia	4 (22)	0	2 (13)	0
Hyponatremia	2 (11)	0	3 (19)	0
Stomatitis	2 (11)	0	3 (19)	0
Vomiting	2 (11)	0	3 (19)	0
Headache	2 (11)	1 (6)	2 (13)	0
Peripheral sensory neuropathy	1 (6)	0	3 (19)	0
Platelet count decreased	2 (11)	0	2 (13)	1 (6)
Diabetes mellitus	1 (6)	1 (6)	2 (13)	0
Vasculitis	0	0	3 (19)	0
Alanine aminotransferase increased	0	0	2 (13)	1 (6)
Bacterial infection	2 (11)	1 (6)	0	0
Hyperglycemia	2 (11)	1 (6)	0	0
Pneumonia	1 (6)	1 (6)	1 (6)	1 (6)
Acute myocardial infarction	0	0	1 (6)	1 (6)
Aspartate aminotransferase increased	0	0	1 (6)	1 (6)
Cardiac tamponade	1 (6)	1 (6)	0	0
Embolism arterial	1 (6)	1 (6)	0	0
Hypertension	1 (6)	1 (6)	0	0
Hypocalcemia	0	0	1 (6)	1 (6)
Loss of consciousness	0	0	1 (6)	1 (6)
Lung infection	0	0	1 (6)	1 (6)
Sepsis	0	0	1 (6)	1 (6)
Syncope	0	0	1 (6)	1 (6)
Type 1 diabetes mellitus	1 (6)	1 (6)	0	0

Listed are all adverse events that occurred during the treatment period and up to 90 days after the last dose of study treatment or up to the start of any subsequent therapy (whichever occurred first). The events are listed in descending order of frequency for any-grade events across both the treatment arms

EP platinum-etoposide