Table 4.

Adverse events recorded during the core study, regardless of event severitya

CyclosporineAzathioprine
n (%)Incidence Densitybn (%)Incidence Densityb
No. of patients3633
Leukopenia4 (11.1)6.110 (30.3)16.7
Anemia5 (13.9)7.65 (15.2)8.4
Hypertension7 (19.4)10.65 (15.2)8.4
Hypercholesterolemia2 (5.6)3.04 (12.1)6.7
Gum hyperplasia2 (5.6)3.000.0
Hypertrichosis2 (5.6)3.000.0
Diabetes00.01 (3.0)1.7
Hyperkalemia1 (2.8)1.500.0
Hypertensive crisis1 (2.8)1.500.0
Infections7 (19.4)10.614 (42.4)23.4
Arthralgias14 (38.9)21.23 (9.1)5.0
Gastrointestinal disorders11 (30.6)16.73 (9.1)5.0
  • a In no case hospitalization was required. Numbers shown are the counts of patients who reported each adverse event. Patients reporting multiple events are therefore counted for each reported adverse event.

  • b Number of events per 100 patients-years of follow-up.