Table 5.

Treatment administration and SAEs

	Arm A (n = 33)	Arm B (n = 23)
Total number of cycles	118	71
Causes of treatment failure
Progression of disease	1	0
G4 toxicity	2	6
Death	1	1
Patient refusal	1	1
Investigator’s decision	2	3
Other	1	1
Total	8	12
Severe adverse events (% of cycles)a	13 (11)	16 (23)
No. of patients involved (% of pts. treated)b	10 (30)	14 (60)

^aP = 0.07,

^bP = 0.15. SAE: Severe adverse event.