Table 4.

QTc evaluation and results in the PALOMA-2 and MONALEESA-2 trials.^4,5,60,61

	Participants	Evaluation	Timing	Results
PALOMA-2 60,61	Substudy ECG (n = 123) Basal QTc < 481 ms.	Preferable automatic ECG lecture. Triplicate ECG. Centrally manual evaluation.	Day 0: preD, 2, 4, 6 and 8 h later. C1D14: preD, 2, 4, 6 and 8 h later.	No patients had a postbaseline absolute maximum QTc ⩾ 500 ms or a ΔQTc ⩾ 60 ms during the intensive QTc assessment period. Correlation between QTc and palbociclib concentration was weak. Aromatase inhibitors the upper bounds of one-sided 95% confidence interval of ΔQTc for all five QTc postbaseline time points were less than 20 ms, the postbaseline QTcs’ were to be considered noninferior to baseline and no clinically relevant effects of palbociclib in QTc were concluded
	All population (n = 666) Basal QTc < 481 ms	Preferable automatic ECG lecture. Triplicate ECG. Centrally manual evaluation.	Day 0: C1D1, preD C1D14, preD C2D14, preD C4D1, preD C7D1, preD C10D1, preD	QTc prolongation G2: palbociclib: 1.6%, placebo 0.9%. QTc prolongation G3: palbociclib: 0.2%, placebo 0%*.
MONALEESA-2 4,5	All population (n = 668) Basal QTc < 451 ms	Locally automatic ECG lecture. Triplicate ECG. Centrally manual evaluation.	Day 0: C1D1, preD C1D14, preD C1D14, postD C2D1, preD C2D1, postD C3D1, preD C3D1, postD C4D1, preD C5D1, preD C6D1, preD C6D1, postD C7D1, preD C8D1, preD C9D1, preD C9D1, postD	QTc prolongation G2: ribociclib: 3.6%, placebo 0.6%. QTc prolongation G3: palbociclib: 0.6%, placebo 0%.$

^*p values not provided.

^$Statistically significant differences for both G2 and G3 QTc prolongation.