Table 5.
Summary of deaths, serious adverse events and adverse events leading to discontinuations (safety set).
| Buparlisib daily dose (+ imatinib 400 mg) | All patients | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 40 mg | 50 mg | 70 mg | 80 mg | 100 mg | ||||||||
| n = 4, n (%) | n = 4, n (%) | n = 3, n (%) | n = 43, n (%) | 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 |
|
| All deathsa | 2 (50.0) | – | 1 (25.0) | – | 0 | – | 7 (16.3) | – | 2 (33.3) | – | 12 (20.0) | – |
| On-treatment deathsb | 0 | – | 0 | – | 0 | – | 3 (7.0) | – | 0 | – | 3 (5.0) | – |
| AEs | 4 (100) | 2 (50.0) | 4 (100) | 2 (50.0) | 3 (100) | 1 (33.3) | 43 (100) | 29 (67.4) | 6 (100) | 5 (83.3) | 60 (100) | 39 (65.0) |
| Suspected to be drug related | 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) |
| SAEs | 1 (25.0) | 1 (25.0) | 2 (50.0) | 2 (50.0) | 1 (33.3) | 0 | 16 (37.2) | 15 (34.9) | 3 (50.0) | 3 (50.0) | 23 (38.3) | 21 (35.0) |
| Suspected to be drug related | 0 | 0 | 1 (25.0) | 1 (25.0) | 0 | 0 | 5 (11.6) | 5 (11.6) | 2 (33.3) | 2 (33.3) | 8 (13.3) | 8 (13.3) |
| AEs leading to discontinuation | 0 | 0 | 1 (25.0) | 1 (25.0) | 1 (33.3) | 0 | 9 (20.9) | 6 (14.0) | 2 (33.3) | 2 (33.3) | 13 (21.7) | 9 (15.0) |
| Suspected to be drug related | 0 | 0 | 1 (25.0) | 1 (25.0) | 0 | 0 | 6 (14.0) | 4 (9.3) | 2 (33.3) | 2 (33.3) | 9 (15.0) | 7 (11.7) |
| AEs requiring dose interruption and/or change | 1 (25.0) | 1 (25.0) | 1 (25.0) | 1 (25.0) | 1 (33.3) | 1 (33.3) | 32 (74.4) | 17 (39.5) | 3 (50.0) | 1 (16.7) | 38 (63.3) | 21 (35.0) |
| Suspected to be drug related | 0 | 0 | 0 | 0 | 1 (33.3) | 1 (33.3) | 28 (65.1) | 14 (32.6) | 3 (50.0) | 1 (16.7) | 32 (53.3) | 16 (26.7) |
| AEs requiring additional therapy | 4 (100) | 1 (25.0) | 4 (100) | 2 (50.0) | 3 (100) | 1 (33.3) | 41 (95.3) | 22 (51.2) | 6 (100) | 3 (50.0) | 58 (96.7) | 29 (48.3) |
| Suspected to be drug related | 3 (75.0) | 1 (25.0) | 3 (75.0) | 1 (25.0) | 1 (33.3) | 1 (33.3) | 37 (86.0) | 13 (30.2) | 5 (83.3) | 2 (33.3) | 49 (81.7) | 18 (30.0) |
AE adverse event, SAE serious adverse event.
aAll deaths, including those >30 days after the end of treatment.
bDeaths occurring >30 days after the end of treatment are not included.