Table 2.
Most common grade 3/4 AEs that occurred in ≥25% of all patients in any of the treatment groups treated with the triple combination.
| Preferred term | Dose-escalation group 1 (fasting) n = 41 |
Dose-escalation group 2 (fed) n = 42 |
Dose-expansion group 1 (CDK4/6i-naïve) n = 16 |
Dose-expansion group 2 (CDK4/6i-refractory) n = 17 |
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|---|---|---|---|---|---|---|---|---|
| Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
| Total, n (%) | 27 (65.9) | 6 (14.6) | 30 (71.4) | 8 (19.0) | 15 (93.8) | 1 (6.3) | 11 (64.7) | 2 (11.8) |
| Anemia | 5 (12.2) | 0 | 6 (14.3) | 0 | 2 (12.5) | 0 | 1 (5.9) | 0 |
| Stomatitis | 2 (4.9) | 0 | 1 (2.4) | 0 | 3 (18.8) | 0 | 0 | 0 |
| Neutropenia | 11 (26.8) | 0 | 11 (26.2) | 4 (9.5) | 6 (37.5) | 1 (6.3) | 5 (29.4) | 1 (5.9) |
| Neutrophil count decreased | 9 (22.0) | 4 (9.8) | 9 (21.4) | 1 (2.4) | 10 (62.5) | 0 | 6 (35.3) | 1 (5.9) |
| White blood cell count decreased | 8 (19.5) | 0 | 11 (26.2) | 0 | 4 (25.0) | 0 | 5 (29.4) | 0 |
Note: A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple AEs is counted only once in the total row. AEs occurring up to 30 days after the final study treatment administration were included.