Table 2:
Treatment-emergent adverse events in the safety population at the second overall survival interim analysis regardless of attribution
| Abemaciclib plus endocrine therapy (n=2791) |
Endocrine therapy alone (n=2800) |
|||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Any | 1353 (48·5%) | 1289 (46·2%) | 88 (3·2%) | 16 (0·6%) | 2016 (72·0%) | 439 (15·7%) | 22 (0·8%) | 11 (0·4%) |
| Diarrhoea | 2114 (75·7%) | 218 (7·8%) | 0 | 1 (<0·1%) | 238 (8·5%) | 6 (0·2%) | 0 | 0 |
| Fatigue | 1060 (38·0%) | 80 (2·9%) | 0 | 0 | 501 (17·9%) | 4 (0·1%) | 0 | 0 |
| Abdominal pain | 957 (34·3%) | 39 (1·4%) | 0 | 0 | 269 (9·6%) | 9 (0·3%) | 0 | 0 |
| Nausea | 811 (29·1%) | 14 (0·5%) | 0 | 0 | 251 (9·0%) | 2 (0·1%) | 0 | 0 |
| Leukopenia | 734 (26·3%) | 314 (11·3%) | 4 (0·1%) | 0 | 175 (6·3%) | 11 (0·4%) | 0 | 0 |
| Neutropenia | 733 (26·3%) | 529 (19·0%) | 19 (0·7%) | 0 | 134 (4·8%) | 20 (0·7%) | 4 (0·1%) | 0 |
| Arthralgia | 731 (26·2%) | 9 (0·3%) | 0 | 0 | 1031 (36·8%) | 29 (1·0%) | 0 | 0 |
| Anaemia | 626 (22·4%) | 57 (2·0%) | 1 (<0·1%) | 0 | 96 (3·4%) | 11 (0·4%) | 1 (<0·1%) | 0 |
| Headache | 545 (19·5%) | 8 (0·3%) | 0 | 0 | 420 (15·0%) | 5 (0·2%) | 0 | 0 |
| Vomiting | 476 (17·1%) | 15 (0·5%) | 0 | 0 | 127 (4·5%) | 4 (0·1%) | 0 | 0 |
| Hot flush | 427 (15·3%) | 4 (0·1%) | 0 | 0 | 634 (22·6%) | 10 (0·4%) | 0 | 0 |
| Cough | 390 (14·0%) | 1 (<0·1%) | 0 | 0 | 223 (8·0%) | 0 | 0 | 0 |
| Lymphoedema | 346 (12·4%) | 5 (0·2%) | 0 | 0 | 254 (9·1%) | 1 (<0·1%) | 0 | 0 |
| Thrombocytopenia | 337 (12·1%) | 28 (1·0%) | 8 (0·3%) | 0 | 48 (1·7%) | 2 (0·1%) | 2 (0·1%) | 0 |
| Constipation | 334 (12·0%) | 2 (0·1%) | 0 | 0 | 170 (6·1%) | 1 (<0·1%) | 0 | 0 |
| Urinary tract infection | 321 (11·5%) | 16 (0·6%) | 0 | 0 | 204 (7·3%) | 6 (0·2%) | 0 | 0 |
| Alopecia | 318 (11·4%) | 0 | 0 | 0 | 77 (2·8%) | 0 | 0 | 0 |
| Decreased appetite | 315 (11·3%) | 16 (0·6%) | 0 | 0 | 68 (2·4%) | 2 (0·1%) | 0 | 0 |
| Blood creatinine increased | 308 (11·0%) | 3 (0·1%) | 0 | 0 | 28 (1·0%) | 0 | 0 | 0 |
| Rash | 305 (10·9%) | 11 (0·4%) | 0 | 0 | 128 (4·6%) | 0 | 0 | 0 |
| Dizziness | 301 (10·8%) | 4 (0·1%) | 0 | 0 | 190 (6·8%) | 1 (<0·1%) | 0 | 0 |
| Upper respiratory tract infection | 296 (10·6%) | 6 (0·2%) | 0 | 0 | 238 (8·5%) | 0 | 0 | 0 |
| Pain in extremity | 284 (10·2%) | 3 (0·1%) | 0 | 0 | 323 (11·5%) | 4 (0·1%) | 0 | 0 |
| Aspartate aminotransferase increased | 283 (10·1%) | 50 (1·8%) | 3 (0·1%) | 0 | 125 (4·5%) | 15 (0·5%) | 0 | 0 |
| Pyrexia | 279 (10·0%) | 2 (0·1%) | 0 | 0 | 130 (4·6%) | 0 | 0 | 0 |
| Alanine aminotransferase increased | 274 (9·8%) | 72 (2·6%) | 5 (0·2%) | 0 | 138 (4·9%) | 19 (0·7) | 0 | 0 |
| Lymphopenia | 246 (8·8%) | 148 (5·3%) | 3 (0·1%) | 0 | 82 (2·9%) | 14 (0·5) | 0 | 0 |
| Hypertension | 106 (3·8%) | 30 (1·1%) | 0 | 0 | 122 (4·4%) | 49 (1·8%) | 0 | 0 |
| Hypokalaemia | 90 (3·2%) | 28 (1·0%) | 4 (0·1%) | 0 | 25 (0·9%) | 5 (0·2%) | 2 (0·1%) | 0 |
| Gamma-glutamyltransferase increased | 61 (2·2%) | 34 (1·2%) | 5 (0·2%) | 0 | 26 (0·9%) | 5 (0·2%) | 1 (<0·1%) | 0 |
| Other adverse events of interest, composite terms | ||||||||
| Venous thromboembolic event* | 33 (1·2%) | 32 (1·1%) | 6 (0·2%) | 0 | 10 (0.4%) | 8 (0·3%) | 0 | 1 (<0·1%) |
| Pulmonary embolism | 0 | 24 (0·9%) | 4 (0·1%) | 0 | 0 | 3 (0·1%) | 0 | 1 (<0·1%) |
Data are n (%). Data shown are grade 1–2 adverse events that occurred in ≥10% of patients and grade 3 or worse adverse events that occurred in ≥1% of patients.
*
Identified by selected terms in embolic and thrombotic events (Standardised Medical Dictionary for Regulatory Activities queries).