Table 1.

Grade 3 or higher infectious toxicities with AZA in AZA-001 and CALGB 92221 compared with BSC, from Santini, et al (12)

	Rate of event per patient year of exposure
	AZA-001		CALGB 9221
	AZA (N=114)	BSC (N=102)	AZA (N=150)	BSC (N=92
Infections, total*	51%	41%	21%	37%
Bacteremia	1	0	0	0
Bronchitis	0	0	1	0
Cellulitis	2	5	1	2
C. difficile colitis	3	0	0	0
Lower respiratory tract infection	2	0	0	0
Neutropenic sepsis	3	0	0	0
Pneumonia	13	14	5	9
Sepsis	6	5	1	9
Urinary tract infection	3	0	0	2

Includes patients preselected to BSC who subsequently received AZA.

^*Includes other events not listed here.