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A maximum QTcF interval value >500 msec occurred in a similar proportion of patients (2%) in the 2 groups.
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The mean (standard deviation) treatment dose per cycle was 594 mg (134 mg) for the 350‐mg cohort 1, 685 mg (93 mg) for the 400‐mg cohort 2, and 706 mg (219 mg) for 450‐mg cohort 3. The ECG analysis showed a maximum increase in the mean QTcF interval at 2 h after the start of the volasertib infusion.
Therapeutic and supratherapeutic doses produced only small increases in the QTcF interval, which were considered to be clinically irrelevant.
Dalbavancin did not have an effect on the QTcF interval, and an effect exceeding 10 ms could be excluded at all time points after a single i.v. dose of 1000 mg and 1500 mg.
Nilotinib rarely prolonged the QTcF interval.
No patients (0/402) had a treatment-emergent PCS QTcF interval.
No participants had a QTcF interval of ≥480 ms [ 26].
There were no cases of QTcF interval ≥450 ms [ 27].
The numbers of patients with QTcF interval prolongation >60 msec or those with absolute QTcF interval >500 msec were comparable between the treatment groups.
None of the patients experienced arrhythmias attributable to a prolonged QTcF interval.
The average QTcF intervals (average of all scheduled post-dose QTcF measurements up to 24 h post-dose) and the peak QTcF intervals (highest QTcF interval value observed over the period of 10 min to 24 h post-dose) were calculated for all treatment groups on both Days 1 and 14.
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