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 |
