Table 4.
Dose Adjustments and Omissions for Abemaciclib.
| n (%) | Letrozole Part A (N=20) | Anastrozole Part B (N=16) | Tamoxifen Part C (N=16) | Exemestane Part D (N=15) | Parts A–D(N=67) |
|---|---|---|---|---|---|
| Patients with ≥1 dose adjustment or omission | 16 (80.0) | 16 (100.0) | 14 (87.5) | 11 (73.3) | 57 (85.1) |
| Patients with dose reduction | 12 (60.0) | 14 (87.5) | 12 (75.0) | 8 (53.3) | 46 (68.7) |
| 1 dose reduction | 4 (20.0) | 5 (31.3) | 8 (50.0) | 4 (26.7) | 21 (31.3) |
| 2 dose reductions | 7 (35.0) | 7 (43.8) | 3 (18.8) | 3 (20.0) | 20 (29.9) |
| ≥3 dose reductions | 1 (5.0) | 2 (12.5) | 1 (6.3) | 1 (6.7) | 5 (7.5) |
| Total dose reductions | 21 | 25 | 17 | 13 | 76 |
| Reason for dose reduction | |||||
| Adverse event a | 21 (100.0) | 25 (100.0) | 17 (100.0) | 13 (100.0) | 76 (100.0) |
| Diarrhea | 15 (71.4) | 11 (44.0) | 8 (47.1) | 8 (61.5) | 42 (55.3) |
| Fatigue | 5 (23.8) | 3 (12.0) | 4 (23.5) | 1 (7.7) | 13 (17.1) |
| Neutropenia | NR | 3 (12.0) | NR | 1 (7.7) | 4 (5.3) |
| Patients with dose omission | 16 (80.0) | 16 (100.0) | 14 (87.5) | 11 (73.3) | 57 (85.1) |
| Total dose omissions | 130 | 127 | 95 | 96 | 448 |
| Dose omission duration (days); median (range) | 1.0 (1–14) | 1.0 (1–29) | 1.0 (1–20) | 1.0 (1–21) | 1.0 (1–29) |
| Reason for dose omission | |||||
| Adverse event a | 50 (38.5) | 50 (39.4) | 44 (46.3) | 42 (43.8) | 186 (41.5) |
| Diarrhea | 24 (18.5) | 12 (9.4) | 19 (20.0) | 28 (29.2) | 83 (18.5) |
| Other b | 77 (59.2) | 77 (60.6) | 50 (52.6) | 52 (54.2) | 256 (57.1) |
| Missing | 3 (2.3) | 0 | 1 (1.1) | 2 (2.1) | 6 (1.3) |
a
Adverse events of ≥10% incidence in at least one part of the study are listed.
b
Other includes scheduling conflict or treatment availability.
NR, not reported.