Table 2: Adverse drug reactions recorded in cancer patients treated with mistletoe extracts.

System organ class (SOC)Preferred term (PT)Total patientsTotal eventsIncidence (%)

Gastrointestinal disordersDiarrhoea120.05
Nausea220.10
Vomiting220.10
Gastrointestinal disorders total 560.26
General disorders and administration site conditionsChills440.21
Fatigue120.05
Injection site erythema (>5 cm)22241.14
Injection site swelling (>5 cm)440.21
Injection site urticaria (>5 cm)220.10
Local reaction (>5 cm)31391.61
Malaise110.05
Pyrexia1241716.45
General disorders and administration site conditions total 2448.16
InvestigationsBlood glucose increased110.05
Blood pressure decreased110.05
Investigations total 220.10
Nervous system disordersHeadache220.10
Nervous system disorders total 220.10
Skin and subcutaneous tissue disordersPruritus generalised330.16
Rash220.10
Urticaria440.21
Skin and subcutaneous tissue disorders total 90.36
Vascular disordersSyncope110.05
Vascular disorders total 110.05

Total 2648.42

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