Table 2.

Adverse events during the maintenance treatments

Adverse events	Multitarget, n=116			AZA, n=90
	Event No.	Crude Rate, %	Rate per 100 patient-yr	Event No.	Crude Rate, %	Rate per 100 patient-yr
AEs (includes SAEs)a	19	16.4	11.59	40	44.44	35.57
Infection	12	10.3	7.32	9	10.0	8
Herpes zoster	2	1.7	1.22	2	2.2	1.78
Pneumonia	2	1.7	1.22	0	0	0
Upper respiratory tract infection	7	6.0	4.27	6	6.7	5.34
Herpes simplex	1	0.9	0.61	0	0	0
Urinary tract infection	0	0	0	1	1.1	0.89
Liver dysfunctionb	1	0.9	0.61	6	6.7	5.34
Leukopeniaa	9	7.8	5.49	23c	25.6	20.45
Osteonecrosis	1	0.9	0.61	1	1.1	0.89
Upper gastrointestinal symptoms	1	0.9	0.61	5	5.6	4.45
Menstrual disorder	0	0	0	2	2.2	1.78
SAEs	2	1.7	1.22	3	3.3	2.67
Pneumonia	2	1.7	1.22	0	0	0
Liver dysfunction	0	0	0	1	1.1	0.89
Leukopenia	0	0	0	2	2.2	1.78

Leukopenia was defined as a peripheral white blood cell count <4000 cells per 1 μl. The definition of liver dysfunction was a serum alanine aminotransferase and/or aspartate transaminase level >50 U/L. The crude rates were compared using the Fisher exact method. AE, adverse event; SAE, serious adverse event.

^aP<0.01.

^bP<0.05.

^cOnly one patient with leukopenia experienced an infection (herpes zoster); the other 22 patients with leukopenia underwent transient withdrawal or an alteration in the AZA dose.