Table 3:

Phase III trials with CDK4/6 in HR-positive/HER2-negative MBC: safety data

Adverse event (AE)	PALOMA-2			PALOMA-3			MONALEESA-2			MONARCH 3			MONARCH 2
	Grade %			Grade %			Grade %			Grade %			Grade %
	All	3	4	All	3	4	All	3	4	All	3	4	All	3	4
Rash	18	1	–	NR	NR	NR	17.1	0.6	–	NR	NR	NR	11.1	1.1	0
Fatigue	37	2	–	38	2	–	36.5	2.1	0.3	40.1	1.8	–	39.9	2.7	–
Diarrhea	26	1	–	19	–	–	35	1.2	–	81.3	9.5	–	86.4	13.4	0
Nausea	35	<1	–	29	–	–	51.4	2.4	–	38.5	0.9	–	45.1	2.7	–
Decreased appetite	15	1	–	12.8	0.9	–	18.6	1.5	–	24.5	1.2	–	26.5	1.1	0
Neutropenia	80	56	10	78.8	53.3	8.7	74.3	49.7	9.6	41.3	19.6	1.5	46.0	23.6	2.9
Anaemia	24	5	<1	26.1	2.6	0	18.6	0.9	0.3	28.4	5.8	–	29.0	7.0	0.2
Thrombocytopenia	16	1	<1	19.4	1.7	0.6	9	0.6	–	NR	NR	NR	15.6	2.0	1.4
Alopecia	33	–	–	14.8	–	–	33.2	–	–	26.6	–	–	15.6	–	–
QTcF Prolongation	–			–			3.3			–			–
Increased creatinine	–			–			–			19	2.1	–	11.8	0.9	0