Table 3 Treatment-emergent adverse events (≥10%)a,b
Bireociclib plus fulvestrant (n = 204) | Placebo plus fulvestrant (n = 101) | |||||
---|---|---|---|---|---|---|
All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
Any TEAE | 204 (100) | 111 (54.4) | 16 (7.8) | 94 (93.1) | 15 (14.9) | 1 (1.0) |
Diarrhea | 189 (92.6) | 11 (5.4) | 0 | 11 (10.9) | 0 | 0 |
Neutropenia | 178 (87.3) | 55 (27.0) | 9 (4.4) | 14 (13.9) | 1 (1.0) | 1 (1.0) |
Leukopenia | 170 (83.3) | 37 (18.1) | 1 (0.5) | 17 (16.8) | 1 (1.0) | 1 (1.0) |
Anemia | 136 (66.7) | 22 (10.8) | 0 | 13 (12.9) | 0 | 0 |
Nausea | 100 (49.0) | 1 (0.5) | 0 | 13 (12.9) | 0 | 0 |
ALT increased | 97 (47.5) | 8 (3.9) | 1 (0.5) | 24 (23.8) | 1 (1.0) | 0 |
Vomiting | 95 (46.6) | 0 | 0 | 5 (5.0) | 0 | 0 |
AST increased | 87 (42.6) | 7 (3.4) | 0 | 30 (29.7) | 0 | 1 (1.0) |
Blood creatinine increased | 85 (41.7) | 2 (1.0) | 0 | 5 (5.0) | 0 | 0 |
Thrombocytopenia | 73 (35.8) | 7 (3.4) | 1 (0.5) | 6 (5.9) | 0 | 0 |
Weight decreased | 73 (35.8) | 0 | 0 | 10 (9.9) | 1 (1.0) | 0 |
Decreased appetite | 70 (34.3) | 3 (1.5) | 0 | 5 (5.0) | 0 | 0 |
Hypertriglyceridemia | 67 (32.8) | 11 (5.4) | 0 | 16 (15.8) | 3 (3.0) | 0 |
COVID-19 | 66 (32.4) | 1 (0.5) | 0 | 16 (15.8) | 0 | 0 |
Hypercholesterolemia | 63 (30.9) | 0 | 0 | 11 (10.9) | 0 | 0 |
Fatigue | 61 (29.9) | 4 (2.0) | 0 | 12 (11.9) | 0 | 0 |
Hypokalemia | 59 (28.9) | 14 (6.9) | 3 (1.5) | 6 (5.9) | 1 (1.0) | 0 |
Rash | 49 (24.0) | 2 (1.0) | 0 | 1 (1.0) | 0 | 0 |
Abdominal pain | 46 (22.5) | 2 (1.0) | 0 | 3 (3.0) | 0 | 0 |
Hyperuricemia | 46 (22.5) | 0 | 0 | 14 (13.9) | 0 | 0 |
Urinary tract infection | 42 (20.6) | 1 (0.5) | 0 | 13 (12.9) | 0 | 0 |
Blood lactate dehydrogenase increased | 39 (19.1) | 0 | 0 | 8 (7.9) | 0 | 0 |
Hypoproteinemia | 38 (18.6) | 0 | 0 | 7 (6.9) | 0 | 0 |
Suspected COVID-19 | 30 (14.7) | 0 | 0 | 15 (14.9) | 0 | 0 |
γ-glutamyltransferase increased | 28 (13.7) | 2 (1.0) | 0 | 12 (11.9) | 3 (3.0) | 0 |
Hyperglycemia | 23 (11.3) | 0 | 0 | 8 (7.9) | 0 | 0 |
Lymphopenia | 22 (10.8) | 3 (1.5) | 0 | 6 (5.9) | 2 (2.0) | 0 |
Blood creatine phosphokinase increased | 21 (10.3) | 1 (0.5) | 0 | 1 (1.0) | 0 | 0 |