TABLE 3

QTc interval by category between treatment arms

QTc intervalNo. of subjects with the indicated characteristic after the 1st doseP valueNo. of subjects with the indicated characteristic after the 2nd doseP value
DP (n = 47)Placebo (n = 22)DP (n = 46)Placebo (n = 22)
QTc prolongation
    QTcFe
        <450 ms33220.0032022<0.0001
        450–479 ms120200
        480–499 ms1030
        ≥500 ms1030
    QTcFm
        <450 ms38220.048928220.0003
        450–479 ms8014
        480–499 ms004
        ≥500 ms100
Change of QTc over baseline
    QTcFe
        <30 ms29220.00031122<0.0001
        30–59 ms160280
        ≥60 ms2070
    QTcFm
        <30 ms22190.00181419<0.0001
        30–59 ms133143
        ≥60 ms120180