Clinical safety of combined therapy of immune checkpoint inhibitors and Viscum album L. therapy in patients with advanced or metastatic cancer

Table 3 Frequency of AEs during treatment with ICM with or without VA therapy

System Order Class	AE (preferred term), grade 1–2	ICM (n = 7)	VA + ICM (n = 9)
Gastrointestinal	Constipation¹		f
	Vomiting^4, ¹		g
	Abdominal pain upper¹	a, b
	Abdominal colic¹	c
	Diarrhoea¹	c
	Nausea^4, ¹	c
General disorders and administration site	Decreased appetite¹		f
	Pyrexia¹	a	h
	Pain¹		f
	Malaise¹	c	f, h
Metabolism and nutrition disorder	Hyponatraemia¹		i
	Marasmus		f
	Hypercholesterolemia¹	d
Musculoskeletal and connective tissue	Pain in extremity¹		h
Nervous system	Altered visual depth perception¹		h
Renal and urinary	Urinary tract infection¹		f
Respiratory, thoracic and mediastinal	Bronchitis chronic		k
	Respiratory distress¹		g
	Pneumonia staphylococcal¹		g
	Bronchitis¹	e	l
	Cough¹	d
	Pneumonia¹	c
Skin and subcutaneous	Decubitus ulcer		f
	Skin reaction¹	c	i
Surgical and medical procedures	Supportive care		f
Total number of patients experiencing AE		5 (71.4³)	6 (66.7²)

Adverse events (AEs) were classified as MedDRA preferred terms and grouped by System Organ Class. Individual patients having experienced AEs during treatment are indicated by letters a-l (j was dismissed). ICM, immune checkpoint monoclonal antibody; VA, Viscum album L.; ¹, expected according to ICM SmPC, ² as percent from number of patients treated with ICM/VA (n = 9), ³ as percent from number of patients treated with ICM (n = 7), ⁴ adverse drug reaction, moderate

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