TABLE 5

Change in mean QTcF interval by month of treatment#

MonthNumber of patients with measureMean±sd maximum QTcF measureMean±sd change in QTcF from baselineMean±sd change in QTcF from previous monthNumber of patients (%) with QTcF that is >60 ms from baseline
Baseline108385.7±33.9
1105402.5±33.117.6±24.417.6±24.46 (5.7)
277414.6±28.726.5±33.910.1±32.412 (15.6)
394416.1±32.128.5±36.93.2±30.121 (22.3)
486420.8±33.434.2±37.48.2±33.422 (25.6)
589422.7±2933.8±38.51.0±33.621 (23.6)
661426±29.640.2±40.74.2±27.014 (23)
724418.5±34.634.1±57.4−15±36.88 (33.3)
812411.2±32.624.8±42.51±24.03 (25)
910434.1±28.461.9±49.111.7±31.95 (50)
104442±15.658.8±35.49.5±9.01 (25)

ECG measures done on the same day were averaged to arrive at an estimate. #: only one patient included in months 11 and beyond.