Adverse Drug Reactions and Expected Effects to Therapy with Subcutaneous Mistletoe Extracts (Viscum album L.) in Cancer Patients

Table 2

Adverse drug reactions recorded in cancer patients treated with mistletoe extracts.

System organ class (SOC)	Preferred term (PT)	Total patients	Total events	Incidence (%)
Gastrointestinal disorders	Diarrhoea	1	2	0.05
	Nausea	2	2	0.10
	Vomiting	2	2	0.10
Gastrointestinal disorders total		5	6	0.26
General disorders and administration site conditions	Chills	4	4	0.21
	Fatigue	1	2	0.05
	Injection site erythema (>5 cm)	22	24	1.14
	Injection site swelling (>5 cm)	4	4	0.21
	Injection site urticaria (>5 cm)	2	2	0.10
	Local reaction (>5 cm)	31	39	1.61
	Malaise	1	1	0.05
	Pyrexia	124	171	6.45
General disorders and administration site conditions total		157^∗	244	8.16
Investigations	Blood glucose increased	1	1	0.05
	Blood pressure decreased	1	1	0.05
Investigations total		2	2	0.10
Nervous system disorders	Headache	2	2	0.10
Nervous system disorders total		2	2	0.10
Skin and subcutaneous tissue disorders	Pruritus generalised	3	3	0.16
	Rash	2	2	0.10
	Urticaria	4	4	0.21
Skin and subcutaneous tissue disorders total		7^∗	9	0.36
Vascular disorders	Syncope	1	1	0.05
Vascular disorders total		1	1	0.05
Total		162^∗	264	8.42

∗This value is not equal to the sum of patients listed for each adverse drug reaction since some patients experienced multiple reactions.