Table 2. Treatment-Related Adverse Events by Treatment Arma.
Adverse events | Armc | No. (%)b | ||
---|---|---|---|---|
Grade 2 | Grade 3 | Grade 4 | ||
Neutrophil count decreased | 1 | 7 (15) | 11 (24) | 8 (17) |
2 | 6 (13) | 9 (20) | 10 (22) | |
White blood cell decreased | 1 | 13 (28) | 6 (13) | 2 (4) |
2 | 8 (18) | 10 (22) | 4 (9) | |
Alopecia | 1 | 19 (41) | 0 | 0 |
2 | 18 (40) | 0 | 0 | |
Anemia | 1 | 10 (22) | 7 (15) | 1 (2) |
2 | 10 (22) | 4 (9) | 0 | |
Fatigue | 1 | 11 (24) | 0 | 0 |
2 | 13 (29) | 4 (9) | 0 | |
Lymphocyte count decreased | 1 | 5 (11) | 2 (4) | 0 |
2 | 5 (11) | 6 (13) | 0 | |
Anorexia | 1 | 7 (15) | 0 | 0 |
2 | 3 (7) | 1 (2) | 0 | |
Platelet count decreased | 1 | 2 (4) | 2 (4) | 1 (2) |
2 | 2 (4) | 1 (2) | 1 (2) | |
Mucositis oral | 1 | 4 (9) | 1 (2) | 0 |
2 | 1 (2) | 1 (2) | 0 | |
Nausea | 1 | 1 (2) | 0 | 0 |
2 | 3 (7) | 1 (2) | 0 | |
Febrile neutropenia | 1 | 0 | 1 (2) | 0 |
2 | 0 | 1 (2) | 1 (2) | |
Thromboembolic event | 1 | 0 | 0 | 0 |
2 | 0 | 3 (7) | 0 | |
Acute coronary syndrome | 1 | 0 | 0 | 1 (2) |
2 | 0 | 0 | 0 | |
Investigations: thrombotic microangiopathic hemolysis | 1 | 0 | 0 | 1 (2) |
2 | 0 | 0 | 0 |
One grade 5 respiratory failure that was at least possibly related to treatment occurred in arm 2.
All grade 3 to 4 adverse events at least possibly related to treatment and the most common grade 2 adverse events (>10% in at least 1 treatment arm) at least possibly related to treatment were included.
Arm 1 alisertib monotherapy and arm 2 alisertib + fulvestrant.