Table 3.
Most frequent treatment-emergent adverse events occurring in ≥ 25% of patients (by schedule) or grade ≥ 3 adverse events occurring in ≥ 2 patients (by schedule) (phase 1 and 2).
| Treatment-emergent adverse event |
5/14 schedule 150–210 mg/day OPZ (n = 19) |
2/7 schedule 210–330 mg/day OPZ (n = 46) |
||
|---|---|---|---|---|
| Any grade n (%) |
Grade ≥ 3 n (%) |
Any grade n (%) |
Grade ≥ 3 n (%) |
|
| Nausea | 18 (94.7) | 6 (31.6) | 37 (80.4) | 4 (8.7) |
| Diarrhea | 16 (84.2) | 6 (31.6) | 39 (84.8) | 11 (23.9) |
| Vomiting | 14 (73.7) | 2 (10.5) | 24 (52.2) | 5 (10.9) |
| Fatigue | 12 (63.2) | 3 (15.8) | 28 (60.9) | 0 |
| Decreased appetite | 8 (42.1) | 1 (5.3) | 12 (26.1) | 0 |
| Platelet count decreased or thrombocytopenia | 8 (42.1) | 4 (21.1) | 14 (30.4) | 6 (13.0) |
| Anemia | 6 (31.6) | 3 (15.8) | 18 (39.1) | 8 (17.4) |
| Hypertension | 6 (31.6) | 2 (10.5) | 8 (17.4) | 5 (10.9) |
| Hypokalemia | 6 (31.6) | 0 | 5 (10.9) | 0 |
| Constipation | 5 (26.3) | 0 | 22 (47.8) | 4 (8.7) |
| Headache | 2 (10.5) | 0 | 13 (28.3) | 0 |
| Dysgeusia | 3 (15.8) | 0 | 12 (26.1) | 0 |
| Pneumonia | 4 (21.1) | 4 (21.1) | 4 (8.7) | 4 (8.7) |
| White blood cell count decreased | 2 (10.5) | 2 (10.5) | 3 (6.5) | 0 |
| Hypophosphatemia | 2 (10.5) | 2 (10.5) | 4 (8.7) | 3 (6.5) |
| Asthenia | 2 (10.5) | 1 (5.3) | 10 (21.7) | 3 (6.5) |
| Urinary tract infection | 2 (10.5) | 0 | 3 (6.5) | 2 (4.3) |
| Alanine aminotransferase increased | 2 (10.5) | 1 (5.3) | 5 (10.9) | 2 (4.3) |
| Aspartate aminotransferase increased | 2 (10.5) | 1 (5.3) | 4 (8.7) | 2 (4.3) |
| Neutrophil count decreased | 1 (5.3) | 1 (5.3) | 3 (6.5) | 2 (4.3) |
OPZ, oprozomib.