Table 1. Background characteristics.

Item	Category	Safety analysis set n	%
Total		558	100.0
Sex	Male	320	57.3
	Female	236	42.3
	Unknown/not recorded	2	0.4
Age (years)	Mean ± SD	59.3 ± 15.3
	Median (range)	62.0 (16–92)
	<65	325	58.2
	≥65	233	41.8
Body weight (kg)	Mean ± SD	57.79 ± 12.00
	Median (range)	56.80 (28.7–98.6)
First episode/recurrence	First episode	344	61.6
	Recurrence	214	38.4
	1st recurrence	149	26.7
	2nd recurrence	37	6.6
	3rd recurrence	15	2.7
	4th recurrence or more	13	2.3
Tumor excision rate (%)	Mean ± SD	86.9 ± 18.6
	Median (range)	95.0 (5–100)
Pathological tissue type	Glioblastoma	422	75.6
	Anaplastic astrocytoma	42	7.5
	Anaplastic oligodendroglioma	33	5.9
	Anaplastic oligoastrocytoma	16	2.9
	Anaplastic ependymoma	7	1.3
	Other malignant glioma	16	2.9
	Other than malignant glioma	22	3.9
WHO classification of central nervous tumor (malignancy classification)	Grade IV	428	76.7
	Grade III	112	20.1
	Grade II	7	1.3
	Not applicable	11	2.0
Type of tumor lesions	Solitary	477	85.5
	Multiple	79	14.2
	Unknown/not recorded	2	0.4
Tumor lesion site	Above the tentorium	539	96.6
	Below the tentorium	21	3.8
	Unknown/not recorded	1	0.2
Complications	Absent	139	24.9
	Present	418	74.9
	Unknown/not recorded	1	0.2
Complication, cerebral edema	Absent	211	37.8
	Present	346	62.0
	Unknown/not recorded	1	0.2
Complication, renal impairment	Absent	552	98.9
	Present	5	0.9
	Unknown/not recorded	1	0.2
Complication, hepatic function disorder	Absent	548	98.2
	Present	9	1.6
	Unknown/not recorded	1	0.2
Complication, others	Absent	345	61.8
	Present	212	38.0
	Unknown/not recorded	1	0.2
KPS immediately before Gliadel placement	Mean ± SD	72.1 ± 21.2
	Median (range)	80.0 (10–100)
	80–100	291	52.2
	10–70	267	47.8

KPS: Karnofsky performance status, SD: standard deviation, WHO: World Health Organization.