Table 1.

Demographics and tumor characteristics for the target population

	Study SPI-611		Study SPI-612		Pooled Data
Characteristic/Category	Apaziquone (n = 295)	Placebo (n = 271)	Apaziquone (n = 282)	Placebo (n = 298)	Apaziquone (n = 577)	Placebo (n = 569)	Total (n = 1146)
Gender, %
Female	28.8	26.6	28.0	30.2	28.4	28.5	28.4
Male	71.2	73.4	72.0	69.8	71.6	71.5	71.6
Race, %
White	97.3	97.0	97.5	97.0	97.4	97.0	97.2
Black or African American	2.0	1.8	1.8	0.7	1.9	1.2	1.6
Asian	0	0.7	0.7	2.0	0.3	1.4	0.9
Other	0.7	0.4	0	0.3	0.3	0.4	0.3
Age, years
Mean (SD)	66.9 (11.3)	67.7 (10.6)	66.6 (11.9)	65.9 (11.8)	66.8 (11.6)	66.7 (11.3)	66.7 (11.4)
Bladder Cancer History, %
Primary	63.7	60.9	61.3	62.8	62.6	61.9	62.2
Recurrent	36.3	39.1	38.7	37.2	37.4	38.1	37.8
Prior Intravesical Therapies, %
Any Prior IVT	17.6	15.1	15.6	14.0	17.0	13.9	15.4
BCG	14.6	12.9	8.2	5.7	11.4	9.1	10.3
Mitomycin C	7.8	4.4	6.0	6.7	6.9	5.6	6.3
Other IVT	0.7	2.6	5.0	4.0	2.8	3.3	3.1
Tumor Lesion Number at Baseline, %
1 lesion	64.7	66.8	59.2	60.7	62.0	63.6	62.8
2 lesions	17.3	19.9	23.0	17.8	20.1	18.8	19.5
3 lesions	14.2	9.6	11.0	16.4	12.7	13.2	12.9
4 lesions	3.7	3.7	6.7	5.0	5.2	4.4	4.8
Tumor Grade at Baseline, %
G1	73.9	70.1	73.4	78.5	73.7	74.5	74.1
G2	26.1	29.9	26.6	21.5	26.3	25.5	25.9
Time from End of TURBT to Start of
Treatment Instillation, %
≤30 minutes	45.4	53.5	35.1	26.2	40.4	39.2	39.8
31–90 minutes	20.3	14.4	20.2	20.5	20.3	17.6	18.9
>90 minutes	34.2	32.1	44.7	53.4	39.3	43.2	41.3

IVT = Intravesical Therapy; BCG = Bacillus Calmette–Guérin; SD = standard deviation.