Table 3.
AEs >10% (and SAEs <10%) in either treatment arm in premenopausal patients by treatment arm (all causality)
| AE | Grade | Palbociclib N = 301 n (valid %) |
Placebo N = 314 n (valid %) |
Overall N = 615 n (valid %) |
P value |
|---|---|---|---|---|---|
| Patients with AE | Any | 300 (99.7) | 313 (99.7) | 613 (99.7) | 1.00 |
| Patients with grade 3/4 AE | 3-4 | 244 (81.1) | 58 (18.5) | 302 (49.1) | <0.001 |
| Patients with hematologic AE | Any | 298 (99.0) | 263 (83.8) | 561 (91.2) | <0.001 |
| Patients with hematologic grade 3/4 AE | 3-4 | 229 (76.1) | 6 (1.9) | 235 (38.2) | <0.001 |
| Patients with non-hematologic AE | Any | 299 (99.3) | 312 (99.4) | 611 (99.3) | 1.00 |
| Patients with non-hematologic grade 3/4 AE | 3-4 | 57 (18.9) | 52 (16.6) | 109 (17.7) | 0.461 |
| Patients with SAEs | 24 (8.0) | 29 (9.2) | 53 (8.6) | 0.667 | |
| Anemia | Any | 230 (76.4) | 105 (33.4) | 335 (54.5) | <0.001 |
| 3-4 | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1.000 | |
| Leukopenia | Any | 298 (99.0) | 232 (73.9) | 530 (86.2) | <0.001 |
| 3-4 | 173 (57.5) | 3 (1.0) | 176 (28.6) | <0.001 | |
| Neutropenia | Any | 286 (95.0) | 78 (24v8) | 364 (59.2) | <0.001 |
| 3-4 | 218 (72.4) | 5 (1.6) | 223 (36.3) | <0.001 | |
| Febrile neutropenia | Any | 6 (2.0) | 1 (0.3) | 7 (1.1) | 0.064 |
| Thrombocytopenia | Any | 185 (61.5) | 59 (18.8) | 244 (39.7) | <0.001 |
| 3-4 | 2 (0.7) | 0 (0.0) | 2 (0.3) | 0.239 | |
| Non-hematologic toxicities | |||||
| ALAT increased | Any | 57 (18.9) | 69 (22.0) | 126 (20.5) | 0.370 |
| 3-4 | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1.000 | |
| Blood AP increased | Any | 43 (14.3) | 49 (15.6) | 92 (15.0) | 0.653 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| ASAT increased | Any | 58 (19.3) | 54 (17.2) | 112 (18.2) | 0.532 |
| 3-4 | 2 (0.7) | 1 (0.3) | 3 (0.5) | 0.617 | |
| Hyperkalemia | Any | 26 (8.6) | 37 (11.8) | 63 (10.2) | 0.232 |
| 3-4 | 2 (0.7) | 2 (0.6) | 4 (0.7) | 1.000 | |
| Hypernatremia | Any | 33 (11.0) | 28 (8.9) | 61 (9.9) | 0.420 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Hypocalcemia | Any | 132 (43.9) | 104 (33.1) | 236 (38.4) | 0.008 |
| 3-4 | 3 (1.0) | 0 (0.0) | 3 (0.5) | 0.117 | |
| Hypomagnesemia | Any | 88 (29.2) | 92 (29.3) | 180 (29.3) | 1.000 |
| 3-4 | 2 (0.7) | 0 (0.0) | 2 (0.3) | 0.239 | |
| Alopecia | Any | 31 (10.3) | 22 (7.0) | 53 (8.6) | 0.153 |
| Arthralgia | Any | 114 (37.9) | 112 (35.7) | 226 (36.7) | 0.616 |
| 3-4 | 2 (0.7) | 2 (0.6) | 4 (0.7) | 1.000 | |
| Back pain | Any | 34 (11.3) | 39 (12.4) | 73 (11.9) | 0.709 |
| 3-4 | 3 (1.0) | 0 (0.0) | 3 (0.5) | 0.117 | |
| Bone pain | Any | 47 (15.6) | 52 (16.6) | 99 (16.1) | 0.826 |
| 3-4 | 1 (0.3) | 0 (0.0) | 1 (0.2) | 0.489 | |
| Blood creatinine increased | Any | 32 (10.6) | 25 (8.0) | 57 (9.3) | 0.269 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Constipation | Any | 75 (24.9) | 46 (14.6) | 121 (19.7) | 0.002 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Cough | Any | 51 (16.9) | 53 (16.9) | 104 (16.9) | 1.000 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Dyspnea | Any | 32 (10.6) | 18 (5.7) | 50 (8.1) | 0.028 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Diarrhea | Any | 58 (19.3) | 44 (14.0) | 102 (16.6) | 0.084 |
| 3-4 | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1.000 | |
| Fatigue | Any | 203 (67.4) | 161 (51.3) | 364 (59.2) | <0.001 |
| 3-4 | 8 (2.7) | 3 (1.0) | 11 (1.8) | 0.135 | |
| Headache | Any | 73 (24.3) | 87 (27.7) | 160 (26.0) | 0.358 |
| 3-4 | 2 (0.7) | 2 (0.6) | 4 (0.7) | 1.000 | |
| Hot flushes | Any | 157 (52.2) | 172 (54.8) | 329 (53.5) | 0.519 |
| 3-4 | 3 (1.0) | 4 (1.3) | 7 (1.1) | 1.000 | |
| Vulvovaginal dryness | Any | 33 (11.0) | 36 (11.5) | 69 (11.2) | 0.899 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Infection | Any | 184 (61.1) | 166 (52.9) | 350 (56.9) | 0.042 |
| 3-4 | 7 (2.3) | 15 (4.8) | 22 (3.6) | 0.129 | |
| Pyrexia | Any | 38 (12.6) | 27 (8.6) | 65 (10.6) | 0.116 |
| 3-4 | 2 (0.7) | 1 (0.3) | 3 (0.5) | 0.617 | |
| Insomnia | Any | 47 (15.6) | 57 (18.2) | 104 (16.9) | 0.452 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Myalgia | Any | 63 (20.9) | 50 (15.9) | 113 (18.4) | 0.119 |
| 3-4 | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1.000 | |
| Nausea | Any | 80 (26.6) | 73 (23.2) | 153 (24.9) | 0.352 |
| 3-4 | 0 (0.0) | 1 (0.3) | 1 (0.2) | 1.000 | |
| Vomiting | Any | 28 (9.3) | 34 (10.8) | 62 (10.1) | 0.593 |
| 3-4 | 0 (0.0) | 2 (0.6) | 2 (0.3) | 0.499 | |
| Edema peripheral | Any | 57 (18.9) | 54 (17.2) | 111 (18.0) | 0.601 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Lymphedema | Any | 34 (11.3) | 30 (9.6) | 64 (10.4) | 0.511 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Pain in extremity | Any | 36 (12.0) | 31 (9.9) | 67 (10.9) | 0.439 |
| 3-4 | 1 (0.3) | 1 (0.3) | 2 (0.3) | 1.000 | |
| Muscle spams | Any | 33 (11.0) | 23 (7.3) | 56 (9.1) | 0.125 |
| 3-4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA | |
| Stomatitis | Any | 99 (32.9) | 24 (7.6) | 123 (20.0) | <0.001 |
| 3-4 | 2 (0.7) | 1 (0.3) | 3 (0.5) | 0.617 |
AEs, adverse events; ALAT, alanine aminotransferase; AP, alkaline phosphatase; ASAT, aspartate aminotransferase; NA, not applicable; SAEs, serious adverse events.