Treatment-emergent adverse events of any grade reported in 10% or more of patients overall
| Adverse event, n . | 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 | 3 | 3 | 3 | 6 | 3 | 6 | 7 | 31 (100) |
| Nausea | 1 | — | 2 | 6 | 1 | 5 | 6 | 21 (68) |
| Diarrhea | 3 | 1 | 2 | 5 | 1 | 3 | 3 | 18 (58) |
| Fatigue | 1 | 1 | 1 | 2 | 1 | 6 | 4 | 16 (52) |
| Vomiting | 1 | — | 1 | 5 | — | 2 | 5 | 14 (45) |
| Constipation | 1 | — | — | 3 | 1 | 4 | 4 | 13 (42) |
| Back pain | 1 | 2 | 1 | — | 1 | 2 | 1 | 8 (26) |
| Dizziness | 2 | — | 1 | 2 | — | 1 | 2 | 8 (26) |
| Asthenia | 1 | — | 1 | 1 | — | 1 | 3 | 7 (23) |
| Pain in extremity | 1 | — | 1 | 1 | 1 | 2 | 1 | 7 (23) |
| Headache | 1 | — | 1 | — | 1 | 1 | 2 | 6 (19) |
| Nasopharyngitis | 2 | — | — | 2 | 1 | — | 1 | 6 (19) |
| Paresthesia | — | — | 1 | 1 | 2 | — | 2 | 6 (19) |
| Peripheral edema | 1 | — | 1 | 1 | 1 | 1 | 1 | 6 (19) |
| Pyrexia | 1 | 1 | 1 | 1 | 1 | 1 | — | 6 (19) |
| Abdominal pain | — | — | 1 | — | 1 | — | 3 | 5 (16) |
| Cough | 2 | — | — | — | — | 2 | 1 | 5 (16) |
| Dyspnea | 1 | — | 1 | — | — | 2 | 1 | 5 (16) |
| Insomnia | 1 | — | — | 1 | 1 | — | 2 | 5 (16) |
| Muscle spasms | 2 | — | 2 | — | — | 1 | — | 5 (16) |
| Palpitations | — | — | 1 | — | — | 2 | 2 | 5 (16) |
| Pharyngolaryngeal pain | 1 | 1 | — | 1 | — | 1 | 1 | 5 (16) |
| Abdominal distension | — | — | — | 1 | — | 1 | 2 | 4 (13) |
| Anorexia | — | — | — | — | — | 2 | 2 | 4 (13) |
| Arthralgia | — | — | 1 | 2 | — | — | 1 | 4 (13) |
| Dyspepsia | 1 | — | 1 | — | — | 2 | — | 4 (13) |
| Edema | 1 | — | 1 | — | — | 2 | — | 4 (13) |
| Orthostatic hypotension | — | — | — | 1 | — | 1 | 2 | 4 (13) |
| Rash | 2 | 1 | — | — | — | — | 1 | 4 (13) |
| Upper respiratory tract infection | — | — | 1 | 2 | — | — | 1 | 4 (13) |
| Anxiety | 1 | — | — | — | — | 1 | 1 | 3 (10) |
| Bronchitis | — | — | 2 | 1 | — | — | — | 3 (10) |
| Dry mouth | — | — | — | — | — | 1 | 2 | 3 (10) |
| Groin pain | — | — | 1 | — | 1 | 1 | — | 3 (10) |
| Hyperhidrosis | — | — | — | 1 | — | 2 | — | 3 (10) |
| Hypoesthesia | — | — | — | — | 2 | 1 | — | 3 (10) |
| Hypotension | — | 1 | — | 1 | — | 1 | — | 3 (10) |
| Influenza | — | — | 1 | — | 1 | 1 | — | 3 (10) |
| Influenza-like illness | 1 | — | 2 | — | — | — | — | 3 (10) |
| Night sweats | 1 | — | — | — | 1 | 1 | — | 3 (10) |
| Oral herpes | 1 | 1 | — | 1 | — | — | — | 3 (10) |
| Peripheral sensory neuropathy | — | — | 1 | 1 | — | — | 1 | 3 (10) |
| Pruritis | — | 1 | — | 1 | 1 | — | — | 3 (10) |
| Thrombocytopenia | — | — | — | — | — | 1 | 2 | 3 (10) |
| Adverse event, n . | 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 | 3 | 3 | 3 | 6 | 3 | 6 | 7 | 31 (100) |
| Nausea | 1 | — | 2 | 6 | 1 | 5 | 6 | 21 (68) |
| Diarrhea | 3 | 1 | 2 | 5 | 1 | 3 | 3 | 18 (58) |
| Fatigue | 1 | 1 | 1 | 2 | 1 | 6 | 4 | 16 (52) |
| Vomiting | 1 | — | 1 | 5 | — | 2 | 5 | 14 (45) |
| Constipation | 1 | — | — | 3 | 1 | 4 | 4 | 13 (42) |
| Back pain | 1 | 2 | 1 | — | 1 | 2 | 1 | 8 (26) |
| Dizziness | 2 | — | 1 | 2 | — | 1 | 2 | 8 (26) |
| Asthenia | 1 | — | 1 | 1 | — | 1 | 3 | 7 (23) |
| Pain in extremity | 1 | — | 1 | 1 | 1 | 2 | 1 | 7 (23) |
| Headache | 1 | — | 1 | — | 1 | 1 | 2 | 6 (19) |
| Nasopharyngitis | 2 | — | — | 2 | 1 | — | 1 | 6 (19) |
| Paresthesia | — | — | 1 | 1 | 2 | — | 2 | 6 (19) |
| Peripheral edema | 1 | — | 1 | 1 | 1 | 1 | 1 | 6 (19) |
| Pyrexia | 1 | 1 | 1 | 1 | 1 | 1 | — | 6 (19) |
| Abdominal pain | — | — | 1 | — | 1 | — | 3 | 5 (16) |
| Cough | 2 | — | — | — | — | 2 | 1 | 5 (16) |
| Dyspnea | 1 | — | 1 | — | — | 2 | 1 | 5 (16) |
| Insomnia | 1 | — | — | 1 | 1 | — | 2 | 5 (16) |
| Muscle spasms | 2 | — | 2 | — | — | 1 | — | 5 (16) |
| Palpitations | — | — | 1 | — | — | 2 | 2 | 5 (16) |
| Pharyngolaryngeal pain | 1 | 1 | — | 1 | — | 1 | 1 | 5 (16) |
| Abdominal distension | — | — | — | 1 | — | 1 | 2 | 4 (13) |
| Anorexia | — | — | — | — | — | 2 | 2 | 4 (13) |
| Arthralgia | — | — | 1 | 2 | — | — | 1 | 4 (13) |
| Dyspepsia | 1 | — | 1 | — | — | 2 | — | 4 (13) |
| Edema | 1 | — | 1 | — | — | 2 | — | 4 (13) |
| Orthostatic hypotension | — | — | — | 1 | — | 1 | 2 | 4 (13) |
| Rash | 2 | 1 | — | — | — | — | 1 | 4 (13) |
| Upper respiratory tract infection | — | — | 1 | 2 | — | — | 1 | 4 (13) |
| Anxiety | 1 | — | — | — | — | 1 | 1 | 3 (10) |
| Bronchitis | — | — | 2 | 1 | — | — | — | 3 (10) |
| Dry mouth | — | — | — | — | — | 1 | 2 | 3 (10) |
| Groin pain | — | — | 1 | — | 1 | 1 | — | 3 (10) |
| Hyperhidrosis | — | — | — | 1 | — | 2 | — | 3 (10) |
| Hypoesthesia | — | — | — | — | 2 | 1 | — | 3 (10) |
| Hypotension | — | 1 | — | 1 | — | 1 | — | 3 (10) |
| Influenza | — | — | 1 | — | 1 | 1 | — | 3 (10) |
| Influenza-like illness | 1 | — | 2 | — | — | — | — | 3 (10) |
| Night sweats | 1 | — | — | — | 1 | 1 | — | 3 (10) |
| Oral herpes | 1 | 1 | — | 1 | — | — | — | 3 (10) |
| Peripheral sensory neuropathy | — | — | 1 | 1 | — | — | 1 | 3 (10) |
| Pruritis | — | 1 | — | 1 | 1 | — | — | 3 (10) |
| Thrombocytopenia | — | — | — | — | — | 1 | 2 | 3 (10) |