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Table 3 Treatment-emergent adverse events occurring in ≥ 10% of the premenopausal population of the MONARCH 2 trial

From: Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from 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
  1. G, grade
  2. a1 patient (1.4%) experienced grade 3 febrile neutropenia in the abemaciclib arm