Table 1.
Summary of the most common treatment-emergent adverse events
| ORd | OCyd | OMP | ||||||
|---|---|---|---|---|---|---|---|---|
| n (%) | 5/14 Schedule, 150–210 mg OPZ N = 13 | 2/7 Schedule, 210 or 240 mg OPZ N = 5 | 2/7 Schedule, 210 mg OPZ N = 3 | 2/7 Schedule, 180 mg OPZ N = 7 | ||||
| Any grade | Grade 3 or greater | Any grade | Grade 3 or greater | Any grade | Grade 3 or greater | Any grade | Grade 3 or greater | |
| Nausea | 11 (84.6) | 0 | 5 (100.0) | 0 | 2 (66.7) | 0 | 5 (71.4) | 1 (14.3) |
| Cough | 2 (15.4) | 0 | 5 (100.0) | 0 | 1 (33.3) | 0 | 0 | 0 |
| Diarrhea | 11 (84.6) | 2 (15.4) | 4 (80.0) | 0 | 2 (66.7) | 0 | 6 (85.7) | 1 (14.3) |
| Fatigue | 7 (53.8) | 1 (7.7) | 4 (80.0) | 1 (20.0) | 1 (33.3) | 1 (33.3) | 2 (28.6) | 0 |
| Vomiting | 7 (53.8) | 0 | 4 (80.0) | 0 | 0 | 0 | 4 (57.1) | 1 (14.3) |
| Dizziness | 7 (53.8) | 1 (7.7) | 3 (60.0) | 0 | 1 (33.3) | 0 | 1 (14.3) | 1 (14.3) |
| Constipation | 6 (46.2) | 0 | 3 (60.0) | 0 | 0 | 0 | 3 (42.9) | 0 |
| Decreased appetite | 3 (23.1) | 0 | 3 (60.0) | 0 | 1 (33.3) | 0 | 1 (14.3) | 0 |
| Dysgeusia | 3 (23.1) | 0 | 3 (60.0) | 0 | 1 (33.3) | 0 | 1 (14.3) | 0 |
| Headache | 2 (15.4) | 0 | 0 | 0 | 2 (66.7) | 0 | 1 (14.3) | 0 |
| Dyspepsia | 1 (7.7) | 0 | 3 (60.0) | 0 | 1 (33.3) | 0 | 0 | 0 |
| Thrombocytopenia | 4 (30.8) | 2 (15.4) | 0 | 0 | 0 | 0 | 2 (28.6) | 0 |
| Hypokalemia | 4 (30.8) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Upper respiratory tract infection | 2 (15.4) | 0 | 0 | 0 | 2 (66.7) | 0 | 0 | 0 |
| Abdominal distension | 2 (15.4) | 1 (7.7) | 2 (40.0) | 0 | 2 (66.7) | 0 | 1 (14.3) | 0 |
| Muscle spasms | 2 (15.4) | 0 | 2 (40.0) | 0 | 2 (66.7) | 0 | 1 (14.3) | 0 |
| Vision blurred | 1 (7.7) | 0 | 2 (40.0) | 0 | 2 (66.7) | 0 | 0 | 0 |
| Hypotension | 4 (30.8) | 2 (15.4) | 1 (20.0) | 0 | 0 | 0 | 0 | 0 |
| Asthenia | 2 (15.4) | 0 | 1 (20.0) | 0 | 1 (33.3) | 0 | 2 (28.6) | 0 |
| Insomnia | 2 (15.4) | 0 | 3 (60.0) | 0 | 0 | 0 | 0 | 0 |
| Hypocalcemia | 1 (7.7) | 0 | 3 (60.0) | 1 (20.0) | 0 | 0 | 0 | 0 |
| Tremor | 1 (7.7) | 0 | 3 (60.0) | 0 | 0 | 0 | 0 | 0 |
| Dysphonia | 0 | 0 | 3 (60.0) | 0 | 0 | 0 | 0 | 0 |
| AST increased | 1 (7.7) | 0 | 1 (20.0) | 0 | 0 | 0 | 2 (28.6) | 1 (14.3) |
| Dyspnea exertional | 1 (7.7) | 0 | 1 (20.0) | 0 | 0 | 0 | 2 (28.6) | 1 (14.3) |
| Tachycardia | 0 | 0 | 1 (20.0) | 0 | 2 (66.7) | 0 | 0 | 0 |
| Edema | 1 (7.7) | 0 | 0 | 0 | 1 (33.3) | 0 | 2 (28.6) | 0 |
| ALT increased | 1 (7.7) | 1 (7.7) | 0 | 0 | 1 (33.3) | 0 | 2 (28.6) | 2 (28.6) |
| Hypertension | 0 | 0 | 2 (40.0) | 0 | 0 | 0 | 2 (28.6) | 1 (14.3) |
| Fluid retention | 0 | 0 | 0 | 0 | 0 | 0 | 2 (28.6) | 0 |
| Abdominal pain upper | 1 (7.7) | 0 | 0 | 0 | 0 | 0 | 3 (42.9) | 0 |
The most common any-grade adverse events listed are those that occurred in ≥4 patients in the ORd, 5/14 cohort; or ≥3 patients in the ORd, 2/7 cohort; or ≥2 patients in the OCyd cohort; or ≥2 patients in the OMP cohort
AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, OCyd oprozomib, cyclophosphamide, and dexamethasone; OMP oprozomib, melphalan, and prednisone; OPZ oprozomib, ORd oprozomib, lenalidomide, and dexamethasone