Table 2.

Common all-causality AES ( ≥ 15% in either arm) in MONALEESA-2, -3 and -7 (pooled data, safety set).

n (%)	Ribociclib + endocrine therapya, n = 1065			Placebo + endocrine therapy, n = 818
Grade (CTCAE v4.03)	All	3	4	All	3	4
Any AE	1052 (99)	699 (66)	158 (15)	782 (96)	245 (30)	26 (3)
Haematologic AEs
Neutropeniab	788 (74)	550 (52)	91 (9)	43 (5)	12 (1)	1 (<1)
Leukopeniac	330 (31)	180 (17)	13 (1)	36 (4)	7 (1)	0
Anaemiad	200 (19)	28 (3)	2 (<1)	51 (6)	12 (1)	0
Non-haematologic AEs
Nausea	475 (45)	15 (1)	0	219 (27)	4 (<1)	0
Fatigue	348 (33)	19 (2)	1 (<1)	249 (30)	4 (<1)	0
Diarrhoea	317 (30)	16 (2)	0	176 (22)	5 (1)	0
Arthralgia	310 (29)	7 (1)	1 (<1)	243 (30)	8 (1)	0
Vomiting	284 (27)	21 (2)	0	128 (16)	3 (<1)	0
Alopecia	256 (24)	0	0	97 (12)	0	0
Constipation	253 (24)	8 (1)	0	129 (16)	0	0
Headache	252 (24)	5 (<1)	0	177 (22)	4 (<1)	0
Hot flush	223 (21)	2 (<1)	0	200 (24)	0	0
Cough	218 (21)	0	0	132 (16)	0	0
Back pain	211 (20)	20 (2)	0	153 (19)	7 (1)	0
Rash	187 (18)	6 (1)	0	63 (8)	0	0
Pruritus	169 (16)	3 (<1)	0	47 (6)	0	0
Decreased appetite	163 (15)	6 (1)	0	101 (12)	1 (<1)	0
Increased ALT	161 (15)	71 (7)	15 (1)	48 (6)	8 (1)	0

AE adverse event, ALT alanine transferase, CTCAE Common Terminology Criteria for Adverse Events.

^aPatients from MONALEESA-2 (ribociclib plus letrozole group), MONALEESA-3 (ribociclib plus fulvestrant group) and MONALEESA-7 (ribociclib plus non-steroidal aromatase inhibitor group).

^b“Neutropenia” includes “neutropenia,” “decreased neutrophil count,” “febrile neutropenia,” “granulocytopenia” and “neutropenia sepsis.”

^c“Leukopenia” includes “leukopenia,” “decreased white blood cell count,” “lymphopenia” and “decreased lymphocyte count.”

^d“Anaemia” includes “anaemia,” “decreased haemoglobin,” “macrocytic anaemia” and “decreased red blood cell count.”