Table 5.

Adverse events according to treatment (safety population)

	EIA plus RHT	EIA	p value
Adverse events related to chemotherapy
Number of patients	165	167	..
Number of deaths attributable to treatment*	2 (1.2%)	1 (0.6%)	..
Haematological
Acute Leukaemia†	3 (1.8%)	2 (1.2%)	..
Leucopenia grade 3 or 4	128 (77.6%)	106 (63.5%)	0.005
Thrombocytopenia grade 3 or 4	28 (17.0%)	23 (13.8%)	0.42
Non-haematological grade 3 or 4
Nausea	23 (13.9%)	26 (15.6%)	0.68
Vomiting	15 (9.1%)	9 (5.4%)	0.19
Nephrotoxicity	2 (1.2%)	2 (1.2%)	0.99
Cardiotoxicity	3 (1.8%)	4 (2.4%)	0.71
Neurotoxicity	15 (9.1%)	8 (4.8%)	0.12
Fever of unknown origin	1 (0.6%)	5 (3.0%)	0.10
Adverse events related to hyperthermia
Number of patients	163	..	..
Pain (power-related)
Mild to moderate	66 (40.5%)	..	..
Severe	7 (4.3%)	..	..
Bolus pressure
Mild to moderate	43 (26.4%)	..	..
Severe	8 (4.9%)	..	..
Skin burn
Mild to moderate	29 (17.8%)	..	..
Severe	1 (0.6%)	..	..
Tissue necrosis
Mild to moderate	7 (4.3%)	..	..
Severe	4 (2.5%)	..	..
Localised Infection
Mild to moderate	5 (3.1%)	..	..
Severe	2 (1.2%)	..	..
Others‡
Mild to moderate	23 (14.1%)	..	..
Severe	14 (8.6%)	..	..

All data are n (%) unless otherwise stated. EIA=etoposide+ifosfamide+ doxorubicin. RHT=regional hyperthermia.

^*All patients died from neutropenic sepsis.

^†Four patients developed acute myeloid leukemia, and one patient developed acute lymphoblastic leukemia.

^‡Other reasons: claustrophobia, not power-related pain, wound healing disorder, nausea.