Table 5. Significantly different treatment-emergent adverse events and infections at 36 monthsa

Adverse EventSRL-CsA-ST (n = 215)SRL-ST (n = 215)P Valueb
a ALT, alanine transaminase; AST, aspartate transaminase.
b Fisher exact test, SRL-CsA-ST versus SRL-ST in randomly assigned patients.
Higher in SRL-CsA-ST group
    creatinine increased33.0%19.1%0.001
    hypertension24.2%10.2%<0.001
    hyperuricemia16.7%7.4%0.005
    abnormal kidney function17.7%7.4%0.002
    CsA nephrotoxicity10.2%2.8%0.003
    edema10.2%4.2%0.024
    toxic nephropathy6.0%0.9%0.006
    gingival hyperplasia7.0%2.3%0.037
    hyperkalemia2.8%0%0.030
    Herpes zoster6.5%0.9%0.004
Higher in SRL-ST group
    thrombocytopenia5.6%12.1%0.026
    ALT increased5.1%16.3%<0.001
    AST increased3.7%12.6%0.001
    hypokalemia3.3%10.2%0.006
    healing abnormal1.4%5.6%0.032
    rectal disorder0.9%4.7%0.036
    ileus0.0%2.8%0.030