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Table 6 Vital signs, hematological and biochemical abnormalities over 12 months of treatment (safety population)

From: Efficacy and safety of concentration-controlled everolimus with reduced-dose cyclosporine in Japanese de novo renal transplant patients: 12-month results

  Everolimus 1.5 mg (n= 61) MMF 2 g (n= 61)
SBP (mmHg)   
 ≤90 mmHg or <75 mmHga 1 (1.6) 0 (0.0)
 ≥180 mmHg or >200 mmHgb 9 (14.8) 6 (9.8)
DBP (mmHg)   
 ≤50 mmHg or <40 mmHg 4 (6.6) 0 (0.0)
 ≥105 mmHg or >115 mmHg 14 (23.0) 16 (26.2)
Hematology   
 Platelets, low: <50 k/mm3 0 (0.0) 1 (1.6)
 Eosinophils, high: ≥12% 1 (1.6) 1 (1.6)
 Hemoglobin, low: <7 g/dl 5 (8.2) 5 (8.2)
 Lymphocytes, low: ≤1,000/mm3 48 (78.7) 56 (91.8)
Leukocytes   
 Low: ≤2.0 k/mm3 0 (0.0) 1/61(1.6)
 High: ≥16 k/mm3 32 (52.5) 20 (32.8)
Neutrophils, low: ≤1,000/mm3 0 (0.0) 2 (3.3)
Lipids   
 Total cholesterol, high: ≥350 mg/dl 2 (3.3) 1 (1.6)
 Triglycerides, high: ≥750 mg/dl 1 (1.6) 0 (0.0)
Cholesterol (total)/HDL ratio   
 High: ≥5 and ≤7 24 (39.3) 17 (27.9)
 Very high: >7 5 (8.2) 3 (4.9)
Lipid modifying agents 42 (68.9) 24 (39.3)
Number of patients with normalized cholesterol values after statin treatment (n/month) 16/18 (88.9) 6/7 (85.7)
Number of patients with normalized triglyceride values after statin treatment 9/12 (75) 3/4 (75)
  1. Data presented as n (%). aDecrease from baseline ≥30 mmHg. bIncrease from baseline ≥30 mmHg. DBP, diastolic blood pressure; HDL, high-density lipoprotein; SBP, systolic blood pressure.