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. 2023 Mar 9;9(6):815–824. doi: 10.1001/jamaoncol.2022.7949

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
a

One grade 5 respiratory failure that was at least possibly related to treatment occurred in arm 2.

b

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.

c

Arm 1 alisertib monotherapy and arm 2 alisertib + fulvestrant.

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