Table 3.

Number of patients with adverse events and serious adverse events from baseline to 24 months.

	SLS I-CYC (N=79)	SLS II-CYC (N=69)
Adverse event (AE)*
Leukopenia	19	30
Neutropenia	7	5
Anemia	4	13
Hematuria	10	2
Pneumonia	6	4
Serious adverse event (SAE)
Number of patients with SAEs	47	22
Related to treatment†	13	8
Not related to treatment†	34	16
Death	6	11

^*Pre-defined by protocol as likely to be related to study drug and to warrant protocoldefined management (except for pneumonia): anemia = Hgb <10 gm/dl or <9 for those with Hgb <11 at enrollment; leukopenia = WBC <2500; neutropenia = neutrophils

<1000; thrombocytopenia = platelets <100,000; hematuria = >25 red blood cells (or 1015 red blood cells on more than one urinalysis) in absence of urinary tract infection or menses.

^†According to consensus classification by Morbidity and Mortality Committee.