Supplementary Table S1 Most frequent treatment-emergent AEs (any grade) in ≥15 % of patients by alisertib dose and East Asian race (safety population)
/ Alisertib dose / East Asian race /AE, n (%) / 30 mg BID
(n=30) / 40 mg BID
(n=6) / Chinese
(n=22) / Korean
(n=13) / All patients
(N=36) /
Any AE / 30 (100) / 6 (100) / 22 (100) / 13 (100) / 36 (100)
Neutropenia / 19 (63) / 5 (83) / 13 (59) / 10 (77) / 24 (67)
Diarrhea / 17 (57) / 3 (50) / 10 (45) / 10 (77) / 20 (56)
Stomatitis / 17 (57) / 2 (33) / 11 (50) / 8 (62) / 19 (53)
Alopecia / 14 (47) / 3 (50) / 10 (45) / 7 (54) / 17 (47)
Fatigue / 12 (40) / 2 (33) / 9 (41) / 5 (38) / 14 (39)
Anemia / 9 (30) / 4 (67) / 6 (27) / 6 (46) / 13 (36)
Pyrexia / 8 (27) / 1 (17) / 3 (14) / 6 (46) / 9 (25)
Decreased appetite / 8 (27) / 0 / 3 (14) / 5 (38) / 8 (22)
Abdominal pain / 6 (20) / 1 (17) / 2 (9) / 5 (38) / 7 (19)
Abdominal pain upper / 7 (23) / 0 / 2 (9) / 5 (38) / 7 (19)
Hypokalemia / 4 (13) / 3 (50) / 6 (27) / 1 (8) / 7 (19)
Nausea / 6 (20) / 1 (17) / 2 (9) / 5 (38) / 7 (19)
Pruritus / 7 (23) / 0 / 4 (18) / 3 (23) / 7 (19)
Thrombocytopenia / 6 (20) / 1 (17) / 2 (9) / 4 (31) / 7 (19)
WBC count decreased / 7 (23) / 0 / 6 (27) / 1 (8) / 7 (19)
AST increased / 6 (20) / 0 / 2 (9) / 4 (31) / 6 (17)
PPES / 3 (10) / 3 (50) / 4 (18) / 2 (15) / 6 (17)
Rash maculo-papular / 3 (10) / 3 (50) / 6 (27) / 0 / 6 (17)
Vomiting / 5 (17) / 1 (17) / 2 (9) / 4 (31) / 6 (17)
Abbreviations: AE adverse event, BID twice daily, AST aspartate aminotransferase, PPES palmar-plantar erythrodysesthesia syndrome, WBC white blood cell.