Table 2 Treatment-emergent adverse events

From: MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer

≥15% occurrence in abemaciclib arm, n (%) Abemaciclib plus nonsteroidal AI (n = 327) Placebo plus nonsteroidal AI (n = 161)
All grades Grade 2 Grade 3 Grade 4 All Grades Grade 2 Grade 3 Grade 4
Any adverse event 323 (98.8) 102 (31.2) 169 (51.7) 22 (6.7) 152 (94.4) 70 (43.5) 36 (22.4) 4 (2.5)
Diarrhea 269 (82.3) 99 (30.3) 31 (9.5) 0 52 (32.3) 14 (8.7) 2 (1.2) 0
Neutropenia 143 (43.7) 53 (16.2) 72 (22.0) 6 (1.8) 3 (1.9) 1 (0.6) 1 (0.6) 1 (0.6)
Fatigue 135 (41.3) 59 (18.0) 6 (1.8) 54 (33.5) 21 (13.0) 0
Nausea 135 (41.3) 40 (12.2) 4 (1.2) 33 (20.5) 1 (0.6) 2 (1.2)
Anemia 103 (31.5) 49 (15.0) 23 (7.0) 0 13 (8.1) 3 (1.9) 2 (1.2) 0
Abdominal pain 102 (31.2) 24 (7.3) 6 (1.8) 21 (13.0) 6 (3.7) 2 (1.2)
Vomiting 99 (30.3) 28 (8.6) 5 (1.5) 0 21 (13.0) 2 (1.2) 4 (2.5) 0
Alopecia 90 (27.5) 7 (2.1) 18 (11.2) 0
Decreased appetite 86 (26.3) 30 (9.2) 5 (1.5) 0 17 (10.6) 3 (1.9) 1 (0.6) 0
Leukopenia 72 (22.0) 31 (9.5) 27 (8.3) 1 (0.3) 4 (2.5) 1 (0.6) 0 1 (0.6)
Blood creatinine increased 67 (20.5) 25 (7.6) 6 (1.8) 1 (0.3) 7 (4.3) 1 (0.6) 0 0
Headache 65 (19.9) 11 (3.4) 3 (0.9) 26 (16.1) 6 (3.7) 0
ALT increased 57 (17.4) 16 (4.9) 20 (6.1) 1 (0.3) 12 (7.5) 3 (1.9) 3 (1.9) 0
Arthralgia 57 (17.4) 14 (4.3) 0 33 (20.5) 7 (4.3) 0
Constipation 57 (17.4) 12 (3.7) 2 (0.6) 0 23 (14.3) 5 (3.1) 0 0
AST increased 55 (16.8) 15 (4.6) 12 (3.7) 0 12 (7.5) 2 (1.2) 2 (1.2) 0
Back pain 52 (15.9) 18 (5.5) 3 (0.9) 26 (16.1) 10 (6.2) 1 (0.6)
Rash 50 (15.3) 11 (3.4) 3 (0.9) 0 8 (5.0) 2 (1.2) 0 0
  1. Deaths due to AEs: abemaciclib arm: lung infection (n = 4), embolism (n = 2), respiratory failure (n = 2), cerebral ischemia (n = 1), cerebrovascular accident (n = 1), pneumonitis (n = 1); placebo arm: general physical health deterioration (n = 1), sudden death (n = 1)
  2. ALT alanine aminotransferase, AST aspartate aminotransferase