Table 2.

Adverse events during the maintenance treatments

Adverse eventsMultitarget, n=116AZA, n=90
Event No.Crude Rate, %Rate per 100 patient-yrEvent No.Crude Rate, %Rate per 100 patient-yr
AEs (includes SAEs)a1916.411.594044.4435.57
  Herpes zoster21.71.2222.21.78
  Upper respiratory tract infection76.04.2766.75.34
  Herpes simplex10.90.61000
  Urinary tract infection00011.10.89
 Liver dysfunctionb10.90.6166.75.34
 Upper gastrointestinal symptoms10.90.6155.64.45
 Menstrual disorder00022.21.78
 Liver dysfunction00011.10.89
  • 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.

  • a P<0.01.

  • b P<0.05.

  • c Only 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.