Table 4.
TEAEs for premenopausal patients.
| TEAEs | Abemaciclib + ET, n = 1222, n (%) | ET alone, n = 1209, n (%) | ||||
|---|---|---|---|---|---|---|
| ⩾20% in either arm | Any grade | Grade 3 | Grade 4 | Any grade | Grade 3 | Grade 4 |
| Diarrhea | 1035 (84.7) | 71 (5.8) | 0 | 90 (7.4) | 4 (0.3) | 0 |
| Neutropenia | 591 (48.4) | 234 (19.1) | 9 (0.7) | 98 (8.1) | 12 (1.0) | 3 (0.2) |
| Leukopenia | 472 (38.6) | 146 (11.9) | 1 (0.1) | 105 (8.7) | 6 (0.5) | 0 |
| Abdominal paina | 469 (38.4) | 18 (1.5) | 0 | 126 (10.4) | 4 (0.3) | 0 |
| Fatiguea | 467 (38.2) | 22 (1.8) | 0 | 213 (17.6) | 1 (0.1) | 0 |
| Nauseaa | 339 (27.7) | 4 (0.3) | 0 | 106 (8.8) | 0 | 0 |
| Arthralgiaa | 301 (24.6) | 2 (0.2) | 0 | 416 (34.4) | 9 (0.7) | 0 |
| Anemia | 281 (23.0) | 11 (0.9) | 1 (0.1) | 47 (3.9) | 5 (0.4) | 0 |
| Headache | 266 (21.8) | 3 (0.2) | 0 | 213 (17.6) | 2 (0.2) | 0 |
| Hot flusha | 226 (18.5) | 2 (0.2) | 0 | 332 (27.5) | 6 (0.5) | 0 |
a
Patient has a maximum common terminology criteria for adverse events grade of 3.
ET, endocrine therapy; TEAEs, treatment-emergent adverse events.