Table 3 Treatment-emergent adverse events occurring in ≥ 10% of the premenopausal population of the MONARCH 2 trial
Adverse events (≥ 10% patients in either arm) | Abemaciclib + fulvestrant N = 71 | Placebo + fulvestrant N = 42 | ||||||
|---|---|---|---|---|---|---|---|---|
All | G2 | G3 | G4 | All | G2 | G3 | G4 | |
Any, n (%) | 70 (98.6) | 20 (28.2) | 40 (56.3) | 4 (5.6) | 40 (95.2) | 17 (40.5) | 7 (16.7) | 0 |
Diarrhea | 62 (87.3) | 22 (31.0) | 8 (11.3) | 0 | 10 (23.8) | 1 (2.4) | 0 | 0 |
Neutropeniaa | 42 (59.2) | 9 (12.7) | 28 (39.4) | 2 (2.8) | 3 (7.1) | 1 (2.4) | 1 (2.4) | 0 |
Leukopenia | 31 (43.7) | 15 (21.1) | 12 (16.9) | 0 | 2 (4.8) | 1 (2.4) | 0 | 0 |
Infections and infestations | 31 (43.7) | 26 (36.6) | 1 (1.4) | 0 | 11 (26.2) | 7 (16.7) | 2 (4.8) | 0 |
Abdominal pain | 25 (35.2) | 2 (2.8) | 0 | 0 | 5 (11.9) | 2 (4.8) | 0 | 0 |
Anemia | 24 (33.8) | 15 (21.1) | 7 (9.9) | 0 | 1 (2.4) | 0 | 0 | 0 |
Headache | 24 (33.8) | 7 (9.9) | – | 0 | 13 (31.0) | 2 (4.8) | 0 | 0 |
Vomiting | 23 (32.4) | 5 (7.0) | 1 (1.4) | 0 | 3 (7.1) | 0 | 1 (2.4) | 0 |
Nausea | 20 (28.2) | 6 (8.5) | 1 (1.4) | 0 | 10 (23.8) | 3 (7.1) | 1 (2.4) | 0 |
Respiratory disorders | 16 (22.5) | 4 (5.6) | 1 (1.4) | 0 | 9 (21.4) | 1 (2.4) | 0 | 0 |
Pyrexia | 13 (18.3) | 0 | 0 | 0 | 6 (14.3) | 1 (2.4) | 0 | 0 |
Stomatitis | 13 (18.3) | 3 (4.2) | 0 | 0 | 9 (21.4) | 2 (4.8) | 0 | 0 |
Pruritus | 13 (18.3) | 1 (1.4) | 0 | 0 | 2 (4.8) | 0 | 0 | 0 |
Thrombocytopenia | 12 (16.9) | 4 (5.6) | 0 | 2 (2.8) | – | – | – | – |
Alanine aminotransferase increased | 11 (15.5) | 4 (5.6) | 3 (4.2) | 0 | 2 (4.8) | 0 | 0 | 0 |
Rash | 11 (15.5) | 2 (2.8) | 1 (1.4) | 0 | – | – | – | – |
Constipation | 10 (14.1) | 1 (1.4) | 1 (1.4) | 0 | 7 (16.7) | 0 | 0 | 0 |
Arthralgia | 10 (14.1) | 2 (2.8) | 1 (1.4) | 0 | 7 (16.7) | 2 (4.8) | 0 | 0 |
Injection site reaction | 10 (14.1) | 1 (1.4) | 0 | 0 | 5 (11.9) | 0 | 0 | 0 |
Dry skin | 10 (14.1) | 1 (1.4) | 0 | 0 | – | – | – | – |
Fatigue | 9 (12.7) | 3 (4.2) | 0 | 0 | 10 (23.8) | 4 (9.5) | 0 | 0 |
Edema peripheral | 9 (12.7) | 1 (1.4) | 0 | 0 | 2 (4.8) | 0 | 0 | 0 |
Hot flush | 8 (11.3) | 2 (2.8) | 0 | 0 | 3 (7.1) | 2 (4.8) | 0 | 0 |
Alopecia | 8 (11.3) | 1 (1.4) | 0 | 0 | – | – | – | – |
Aspartate aminotransferase increased | 8 (11.3) | 4 (5.6) | 1 (1.4) | 0 | 4 (9.5) | 1 (2.4) | 0 | 0 |