Table 5.
Dose reductions and interruptions of study drug
| Buparlisib* | Carboplatin† | Buparlisib* | Lomustine‡ | |||
| Buparlisib (80 mg) + carboplatin (n=3) |
Buparlisib (100 mg) + carboplatin (n=14) |
Buparlisib (80 mg) + carboplatin (n=3) |
Buparlisib (100 mg) + carboplatin (n=14) |
Buparlisib (60 mg) + lomustine (n=18) |
Buparlisib (60 mg) + lomustine (n=18) |
|
| Reductions, n (%) | ||||||
| Number of patients requiring dose reduction§ | ||||||
| 0 | 2 (66.7) | 11 (78.6) | 2 (66.7) | 13 (92.9) | 17 (94.4) | 18 (100) |
| 1 | 1 (33.3) | 3 (21.4) | 1 (33.3) | 1 (7.1) | 1 (5.6) | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| ≥3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Number of patients with at least one dose reduction by reason¶ | 1 (33.3) | 3 (21.4) | 1 (33.3) | 1 (7.1) | 1 (5.6) | 0 |
| Adverse event | 1 (33.3) | 3 (21.4) | 1 (33.3) | 1 (7.1) | 1 (5.6) | 0 |
| Interruptions, n (%) | ||||||
| Number of patients with dose interruption§ | ||||||
| 0 | 2 (66.7) | 8 (57.1) | 2 (66.7) | 13 (92.9) | 11 (61.1) | 17 (94.4) |
| 1 | 0 | 4 (28.6) | 1 (33.3) | 1 (7.1) | 5 (27.8) | 1 (5.6) |
| 2 | 0 | 0 | 0 | 0 | 1 (5.6) | 0 |
| ≥3 | 1 (33.3) | 2 (14.3) | 0 | 0 | 1 (5.6) | 0 |
| Number of patients with at least one dose interruption by reason¶ | 1 (33.3) | 6 (42.9) | 1 (33.3) | 1 (7.1) | 7 (38.9) | 1 (5.6) |
| Adverse event | 1 (33.3) | 6 (42.9) | 1 (33.3) | 1 (7.1) | 7 (38.9) | 1 (5.6) |
| Dosing error/technical problems | 1 (33.3) | 0 | 0 | 0 | 1 (5.6) | 0 |
| Number of patients with permanent discontinuation by reason, n (%) | 3 (100) | 14 (100) | 3 (100) | 14 (100) | 18 (100) | 18 (100) |
| Adverse event | 0 | 3 (21.4) | 0 | 2 (14.3) | 3 (16.7) | 3 (16.7) |
| Physician decision | 0 | 0 | 1 (33.3) | 0 | – | – |
| Death | – | – | – | – | 1 (5.6) | 1 (5.6) |
| Progressive disease | 3 (100) | 11 (78.6) | 2 (66.7) | 12 (85.7) | 14 (77.8) | 14 (77.8) |
Percentage is based on ‘n’.
*Denotes the study drug buparlisib
†Denotes the study drug carboplatin
‡Denotes the study drug lomustine.
§A patient with multiple occurrences of the reason for dose reduction or interruption is counted only once in that category
¶A patient with multiple reasons for dose reduction or interruption is counted only once in the total row (ie, ‘number of patients with at least one dose reduction/interruption by reason’)