Table 3 Summary of treatment-emergent adverse events (TEAEs) in the safety population
Culmerciclib plus fulvestrant N = 194 | Placebo plus fulvestrant N = 99 | |||
|---|---|---|---|---|
Any grade | Grade 3 or higher | Any grade | Grade 3 or higher | |
Any TEAEs | 191 (98.5) | 119 (61.3) | 95 (96.0) | 20 (20.2) |
Serious AEs | 36 (18.6) | 32 (16.5) | 10 (10.1) | 7 (7.1) |
TEAEs leading to dose reductions in culmerciclib/placebo | 66 (34.0) | 51 (26.3) | 1 (1.0) | 1 (1.0) |
TEAEs leading to treatment interruptions | 116 (59.8) | 81 (41.8) | 18 (18.2) | 12 (12.1) |
TEAEs leading to treatment discontinuation | 1 (0.5) | — | 0 (0.0) | — |
TEAEs causing death | 2 (1.0) | 2 (2.0) | ||
Diarrhea | 169 (87.1) | 14 (7.2) | 7 (7.1) | 0 (0.0) |
Neutropenia | 156 (80.4) | 48 (24.7) | 17 (17.2) | 4 (4.0) |
Leukopenia | 155 (79.9) | 29 (15.0) | 22 (22.2) | 3 (3.0) |
Anemia | 124 (63.9) | 21 (10.8) | 12 (12.1) | 0 (0.0) |
Vomiting | 117 (60.3) | 4 (2.1) | 7 (7.1) | 0 (0.0) |
Nausea | 82 (42.3) | 2 (1.0) | 9 (9.1) | 0 (0.0) |
Alanine aminotransferase increase | 74 (38.1) | 5 (2.6) | 29 (29.3) | 0 (0.0) |
Aspartate aminotransferase increase | 74 (38.1) | 9 (4.6) | 31 (31.3) | 0 (0.0) |
Hypertriglyceridemia | 74 (38.1) | 14 (7.2) | 30 (30.3) | 2 (2.0) |
Platelet count decrease | 69 (35.6) | 6 (3.1) | 6 (6.1) | 0 (0.0) |
Hypokalemia | 65 (33.5) | 28 (14.4) | 5 (5.1) | 1 (1.0) |
Hypercholesterolemia | 57 (29.4) | 0(0.0) | 22 (22.2) | 1 (1.0) |
Lymphocyte count decrease | 55 (28.4) | 14 (7.2) | 8 (8.1) | 0 (0.0) |
γ-glutamyl transferase increase | 50 (25.8) | 11 (5.7) | 7 (7.1) | 0 (0.0) |
Body weight decrease | 43 (22.2) | 1 (0.5) | 1 (1.0) | 0 (0.0) |
Hyperuricemia | 43 (22.2) | 1 (0.5) | 12 (12.1) | 0 (0.0) |
Urinary tract infection | 39 (20.1) | 2 (1.0) | 14 (14.1) | 0 (0.0) |
Lactate dehydrogenase increase | 37 (19.1) | 1 (0.5) | 4 (4.0) | 0 (0.0) |
Blood creatinine increase | 34 (17.5) | 2 (1.0) | 3 (3.0) | 0 (0.0) |
Asthenia | 33 (17.0) | 6 (3.1) | 4 (4.0) | 0 (0.0) |
Blood alkaline phosphatase increase | 32 (16.5) | 4 (2.1) | 8 (8.1) | 0 (0.0) |
Occult blood positive | 31 (16.0) | 0 (0.0) | 13 (13.1) | 0 (0.0) |
Abdominal pain | 27 (13.9) | 1 (0.5) | 0 (0.0) | 0 (0.0) |
Hypocalcemia | 27 (13.9) | 2 (1.0) | 0 (0.0) | 0 (0.0) |
Decreased appetite | 27 (13.9) | 5 (2.6) | 0 (0.0) | 0 (0.0) |
Hypoalbuminemia | 25 (12.9) | 0 (0.0) | 6 (6.1) | 0 (0.0) |
Pyrexia | 22 (11.3) | 1 (0.5) | 5 (5.1) | 0 (0.0) |
Sinus tachycardia | 22 (11.3) | 0 (0.0) | 2 (2.0) | 0 (0.0) |
Hypophosphatasemia | 21 (10.8) | 1 (0.5) | 1 (1.0) | 0 (0.0) |
Upper abdominal pain | 20 (10.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hyperglycemia | 16 (8.3) | 0 (0.0) | 10 (10.1) | 0 (0.0) |
