Table 4.
Frequent AEs (≥ 20% in all patients), regardless of study drug relationship—qd dosing schedule
| BEZ235 qd | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 400 mg (n = 3) | 800 mg (n = 3) | 1000 mg (n = 8) | 1200 mg (n = 6) | 1400 mg (n = 7) | All patients (N = 27) | |||||||
| PT | All grades n (%) | Grade ¾ n (%) | All grades n (%) | Grade ¾ n (%) | All grades n (%) | Grade ¾ n (%) | All grades n (%) | Grade ¾ n (%) | All grades n (%) | Grade ¾ n (%) | All grades n (%) | Grade ¾ n (%) |
| Total | 3 (100.0) | 2 (66.7) | 3 (100.0) | 1 (33.3) | 8 (100.0) | 4 (50.0) | 6 (100.0) | 6 (100.0) | 7 (100.0) | 5 (71.4) | 27 (100.0) | 18 (66.7) |
| Diarrhea | 2 (66.7) | 0 | 3 (100.0) | 0 | 7 (87.5) | 0 | 6 (100.0) | 0 | 7 (100.0) | 1 (14.3) | 25 (92.6) | 1 (3.7) |
| Decreased appetite | 2 (66.7) | 0 | 3 (100.0) | 0 | 7 (87.5) | 0 | 6 (100.0) | 1 (16.7) | 6 (85.7) | 0 | 24 (88.9) | 1 (3.7) |
| Nausea | 3 (100.0) | 0 | 1 (33.3) | 0 | 7 (87.5) | 0 | 5 (83.3) | 0 | 6 (85.7) | 0 | 22 (81.5) | 0 |
| Stomatitis | 2 (66.7) | 0 | 2 (66.7) | 0 | 3 (37.5) | 0 | 6 (100.0) | 1 (16.7) | 5 (71.4) | 0 | 18 (66.7) | 1 (3.7) |
| Vomiting | 2 (66.7) | 0 | 1 (33.3) | 0 | 4 (50.0) | 0 | 5 (83.3) | 0 | 5 (71.4) | 0 | 17 (63.0) | 0 |
| Fatigue | 1 (33.3) | 0 | 2 (66.7) | 0 | 6 (75.0) | 1 (12.5) | 4 (66.7) | 2 (33.3) | 4 (57.1) | 0 | 17 (63.0) | 3 (11.1) |
| Rash | 1 (33.3) | 0 | 0 | 0 | 5 (62.5) | 1 (12.5) | 1 (16.7) | 1 (16.7) | 4 (57.1) | 0 | 11 (40.7) | 2 (7.4) |
| Lymphopenia | 2 (66.7) | 2 (66.7) | 1 (33.3) | 1 (33.3) | 2 (25.0) | 2 (25.0) | 1 (16.7) | 1 (16.7) | 4 (57.1) | 1 (14.3) | 10 (37.0) | 7 (25.9) |
| Neutropenia | 0 | 0 | 1 (33.3) | 0 | 1 (12.5) | 1 (12.5) | 2 (33.3) | 0 | 4 (57.1) | 3 (42.9) | 8 (29.6) | 4 (14.8) |
| Thrombocytopenia | 0 | 0 | 1 (33.3) | 1 (33.3) | 4 (50.0) | 0 | 0 | 0 | 3 (42.9) | 2 (28.6) | 8 (29.6) | 3 (11.1) |
| Dysgeusia | 0 | 0 | 1 (33.3) | 0 | 2 (25.0) | 0 | 3 (50.0) | 0 | 2 (28.6) | 0 | 8 (29.6) | 0 |
| Cancer pain | 2 (66.7) | 1 (33.3) | 2 (66.7) | 0 | 2 (25.0) | 0 | 1 (16.7) | 0 | 0 | 0 | 7 (25.9) | 1 (3.7) |
| Leukopenia | 0 | 0 | 1 (33.3) | 0 | 2 (25.0) | 1 (12.5) | 1 (16.7) | 0 | 2 (28.6) | 1 (14.3) | 6 (22.2) | 2 (7.4) |
| Pyrexia | 1 (33.3) | 0 | 1 (33.3) | 0 | 2 (25.0) | 0 | 2 (33.3) | 0 | 0 | 0 | 6 (22.2) | 0 |
| Alanine aminotransferase increased | 2 (66.7) | 0 | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 3 (42.9) | 1 (14.3) | 6 (22.2) | 1 (3.7) |
| Blood alkaline phosphatase increased | 1 (33.3) | 0 | 0 | 0 | 2 (25.0) | 0 | 1 (16.7) | 1 (16.7) | 2 (28.6) | 1 (14.3) | 6 (22.2) | 2 (7.4) |
AEs are listed in descending order within PT level in the all patients group
AE adverse event, PT preferred term, qd once daily