Table 2.
TEAEs elicited by bireociclib combination therapy (part 2), with TEAEs occurring in ≥ 20% of all treated patients – safety set
|
Bireociclib plus NSAI (N = 35) |
Bireociclib plus FULV (N = 95) |
|||||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade 2 | Grade 3 | Grade 4 | All grades | Grade 2 | Grade 3 | Grade 4 | |
| All | 35 (100.0) | 34 (97.1) | 26 (74.3) | 4 (11.4) | 95 (100) | 94 (98.9) | 65 (68.4) | 12 (12.6) |
| Leukopenia | 34 (97.1) | 17 (48.6) | 8 (22.9) | 0 | 90 (94.7) | 57 (60.0) | 23 (24.2) | 0 |
| Diarrhea | 33 (94.3) | 17 (48.6) | 4 (11.4) | 0 | 91 (95.8) | 45 (47.4) | 18 (18.9) | 0 |
| Neutropenia | 30 (85.7) | 12 (34.3) | 13 (37.1) | 0 | 88 (92.6) | 49 (51.6) | 27 (28.4) | 5 (5.3) |
| Anemia | 21 (60.0) | 8 (22.9) | 5 (14.3) | 0 | 72 (75.8) | 28 (29.5) | 13 (13.7) | 0 |
| Hypertriglyceridemia | 25 (71.4) | 10 (28.6) | 1 (2.9) | 1 (2.9) | 60 (63.2) | 13 (13.7) | 9 (9.5) | 0 |
| Elevated AST | 25 (71.4) | 1 (2.9) | 0 | 0 | 58 (61.1) | 12 (12.6) | 5 (5.3) | 1 (1.1) |
| Blood creatinine increased | 23 (65.7) | 8 (22.9) | 0 | 0 | 56 (58.9) | 9 (9.5) | 0 | 0 |
| Thrombocytopenia | 20 (57.1) | 7 (20.0) | 2 (5.7) | 0 | 58 (61.1) | 9 (9.5) | 8 (8.4) | 4 (4.2) |
| Elevated ALT | 25 (71.4) | 4 (11.4) | 0 | 0 | 53 (55.8) | 5 (5.3) | 4 (4.2) | 1 (1.1) |
| Hypercholesterolemia | 19 (54.3) | 2 (5.7) | 1 (2.9) | 0 | 52 (54.7) | 3 (3.2) | 0 | 1 (1.1) |
| Hyperuricemia | 20 (57.1) | 0 | 0 | 0 | 48 (50.5) | 1 (1.1) | 0 | 0 |
| Nausea | 15 (42.9) | 2 (5.7) | 0 | 0 | 45 (47.4) | 10 (10.5) | 0 | 0 |
| Hypokalaemia | 19 (54.3) | 0 | 4 (11.4) | 1 (2.9) | 36 (37.9) | 8 (8.4) | 7 (7.4) | 1 (1.1) |
| Vomiting | 15 (42.9) | 4 (11.4) | 0 | 0 | 38 (40.0) | 16 (16.8) | 1 (1.1) | 0 |
| Weight decrease | 15 (42.9) | 1 (2.9) | 1 (2.9) | 0 | 35 (36.8) | 9 (9.5) | 0 | 0 |
| Urinary tract infection | 10 (28.6) | 7 (20.0) | 0 | 0 | 34 (35.8) | 21 (22.1) | 2 (2.1) | 0 |
| Blood lactate dehydrogenase increased | 15 (42.9) | 0 | 0 | 0 | 29 (30.5) | 0 (0) | 0 | 0 |
| Hypoalbuminemia | 12 (34.3) | 0 | 0 | 0 | 30 (31.6) | 3 (3.2) | 0 | 0 |
| Fatigue | 10 (28.6) | 0 | 0 | 0 | 26 (27.4) | 2 (2.1) | 2 (2.1) | 0 |
| Hyperglycaemia | 11 (31.4) | 0 | 0 | 0 | 23 (24.2) | 2 (2.1) | 0 | 0 |
| Gamma-glutamyltransferase increase | 11 (31.4) | 2 (5.7) | 0 | 1 (2.9) | 21 (22.1) | 4 (4.2) | 3 (3.2) | 1 (1.1) |
| Hypophosphatemia | 5 (14.3) | 0 | 0 | 0 | 26 (27.4) | 1 (1.1) | 0 | 0 |
| Hyponatremia | 8 (22.9) | 0 | 0 | 0 | 18 (18.9) | 1 (1.1) | 0 | 0 |
Data are presented as number of patients (incidence)ALT alanine aminotransferase; AST aspartate aminotransferase; FULV fulvestrant; NSAI non-steroidal aromatase inhibitor; TEAEs treatment-emergent adverse events