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. 2020 Mar 9;122(8):1158–1165. doi: 10.1038/s41416-020-0769-y

Table 4.

Adverse events suspected to be treatment related in ≥15% of patients (safety set).

AEs Buparlisib daily dose (+imatinib 400 mg) All patients
40 mg
n = 4, n (%)
50 mg
n = 4, n (%)
70 mg
n = 3, n (%)
80 mg
n = 43, n (%)
100 mg
n = 6, n (%)
n = 60, n (%)
All grades Grade 3 or 4 All grades Grade 3 or 4 All grades Grade 3 or 4 All grades Grade 3 or 4 All grades Grade 3 or 4 All grades Grade 3 or 4
Total 4 (100) 1 (25.0) 4 (100) 1 (25.0) 3 (100) 1 (33.3) 42 (97.7) 20 (46.5) 6 (100) 4 (66.7) 59 (98.3) 27 (45.0)
Nausea 0 0 3 (75.0) 0 1 (33.3) 0 22 (51.2) 1 (2.3) 3 (50.0) 0 29 (48.3) 1 (1.7)
Fatigue 1 (25.0) 0 0 0 2 (66.7) 0 17 (39.5) 0 3 (50.0) 0 23 (38.3) 0
Diarrhoea 2 (50.0) 0 0 0 1 (33.3) 0 16 (37.2) 1 (2.3) 2 (33.3) 1 (16.7) 21 (35.0) 2 (3.3)
Hyperglycaemia 0 0 1 (25.0) 0 1 (33.3) 0 9 (20.9) 0 5 (83.3) 1 (16.7) 16 (26.7) 1 (1.7)
Rash 0 0 0 0 1 (33.3) 0 11 (25.6) 3 (7.0) 1 (16.7) 1 (16.7) 13 (21.7) 4 (6.7)
Decreased appetite 1 (25.0) 1 (25.0) 1 (25.0) 0 0 0 6 (14.0) 1 (2.3) 2 (33.3) 0 10 (16.7) 2 (3.3)

AE adverse event.