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.