Rates of grade 3/4 adverse events (AEs), including those reported in more than 1 patient, serious AEs, and dose modifications due to AEs
| . | Once-weekly bortezomib, cohort no.: dose (n) . | Twice-weekly bortezomib, cohort no.: dose (n) . | Total,N = 31 (%) . | |||||
|---|---|---|---|---|---|---|---|---|
| 1: 0.7 mg/m2 (n = 3) . | 2: 1.0 mg/m2 (n = 3) . | 3: 1.3 mg/m2 (n = 3) . | 4: 1.6 mg/m2 (n = 6) . | 5: 0.7 mg/m2 (n = 3) . | 6: 1.0 mg/m2 (n = 6) . | 7: 1.3 mg/m2 (n = 7) . | ||
| Any grade 3/4 AE | 2 | 1 | 1 | 4 | — | 3 | 5 | 16 (52) |
| Fatigue | 1 | 1 | — | 1 | — | 1 | 3 | 7 (23) |
| Cardiac failure congestive | — | — | — | — | — | 1 | 1 | 2 (6) |
| Thrombocytopenia | — | — | — | — | — | — | 2 | 2 (6) |
| Vomiting | — | — | — | — | — | — | 2 | 2 (6) |
| Any serious AE | 1 | — | 1 | 4 | — | — | 2 | 8 (26) |
| Dose modifications due to AEs | ||||||||
| Drug discontinuation | — | 2 | 1 | 2* | 1 | 1 | 5 | 12 (39) |
| Dose reduction | — | — | — | 2 | — | 1* | 1 | 4 (13) |
| Dose withheld | 1 | 1 | 1 | 1 | 1 | 2 | 5 | 12 (39) |
| Cycle delay | 1 | — | 2 | 4 | 1 | 3 | 1 | 12 (39) |
| . | Once-weekly bortezomib, cohort no.: dose (n) . | Twice-weekly bortezomib, cohort no.: dose (n) . | Total,N = 31 (%) . | |||||
|---|---|---|---|---|---|---|---|---|
| 1: 0.7 mg/m2 (n = 3) . | 2: 1.0 mg/m2 (n = 3) . | 3: 1.3 mg/m2 (n = 3) . | 4: 1.6 mg/m2 (n = 6) . | 5: 0.7 mg/m2 (n = 3) . | 6: 1.0 mg/m2 (n = 6) . | 7: 1.3 mg/m2 (n = 7) . | ||
| Any grade 3/4 AE | 2 | 1 | 1 | 4 | — | 3 | 5 | 16 (52) |
| Fatigue | 1 | 1 | — | 1 | — | 1 | 3 | 7 (23) |
| Cardiac failure congestive | — | — | — | — | — | 1 | 1 | 2 (6) |
| Thrombocytopenia | — | — | — | — | — | — | 2 | 2 (6) |
| Vomiting | — | — | — | — | — | — | 2 | 2 (6) |
| Any serious AE | 1 | — | 1 | 4 | — | — | 2 | 8 (26) |
| Dose modifications due to AEs | ||||||||
| Drug discontinuation | — | 2 | 1 | 2* | 1 | 1 | 5 | 12 (39) |
| Dose reduction | — | — | — | 2 | — | 1* | 1 | 4 (13) |
| Dose withheld | 1 | 1 | 1 | 1 | 1 | 2 | 5 | 12 (39) |
| Cycle delay | 1 | — | 2 | 4 | 1 | 3 | 1 | 12 (39) |
One DLT.