Adverse events related to MRZ that occurred in 10% or more of patients on either treatment schedule, by preferred term and frequency, and all grade 3 or 4–related AEs
| AE MedDRA preferred term . | Related AEs . | Grade 3 or 4–related AEs . | |||
|---|---|---|---|---|---|
| Schedule A* (n = 32) . | Schedule B* (n = 36) . | All patients N = 68 . | Schedule A* (N = 32) . | Schedule B† (N = 36) . | |
| Patients with ≥1 related AE, n (%) | 28 (88%) | 36 (100%) | 64 (94%) | 0 | 0 |
| Fatigue | 13 (41%) | 19 (53%) | 32 (47%) | 2 (6%) | 2 (6%) |
| Headache | 11 (34%) | 18 (50%) | 29 (43%) | 0 | 0 |
| Nausea | 13 (41%) | 13 (36%) | 26 (38%) | 1 (3%) | 1 (3%) |
| Diarrhea | 8 (25%) | 11 (31%) | 19 (28%) | 1 (3%) | 0 |
| Dizziness | 9 (28%) | 9 (25%) | 18 (27%) | 1 (3%) | 0 |
| Vomiting | 10 (31%) | 7 (19%) | 17 (25%) | 1 (3%) | 1 (3%) |
| Hallucination | 4 (13%) | 4 (11%) | 8 (12%) | 0 | 0 |
| Decreased appetite | 2 (6%) | 6 (17%) | 8 (12%) | 0 | 0 |
| Anorexia | 5 (16%) | 2 (6%) | 7 (10%) | 0 | 0 |
| Confusional state | 2 (6%) | 5 (14%) | 7 (10%) | 1 (3%) | 1 (3%)‡ |
| Constipation | 4 (13%) | 3 (8%) | 7 (10%) | 0 | 0 |
| Insomnia | 4 (13%) | 3 (8%) | 7 (10%) | 0 | 1 (3%) |
| Anemia | 2 (6%) | 4 (11%) | 6 (9%) | 1 (3%) | 1 (3%) |
| Blood creatinine increased | 2 (6%) | 4 (11%) | 6 (9%) | 1 (3%)‡ | 1 (3%) |
| Dyspnea | 2 (6%) | 4 (11%) | 6 (9%) | 0 | 0 |
| Neuropathy peripheral | 1 (3%) | 5 (14%) | 6 (9%) | 0 | 1 (3%) |
| Asthenia | 1 (3%) | 4 (11%) | 5 (7%) | 0 | 0 |
| Gait disturbance | 1 (3%) | 4 (11%) | 5 (7%) | 0 | 0 |
| Pain in extremity | 1 (3%) | 4 (11%) | 4 (6%) | 0 | 0 |
| Mental status changes | 3 (9%) | 2 (6%) | 5 (7%) | 1 (3%) | 0 |
| Thrombocytopenia | 2 (6%) | 3 (8%) | 5 (7%) | 1 (3%) | 3 (8%) |
| Balance disorder | 1 (3%) | 3 (8%) | 4 (6%) | 1 (3%) | 0 |
| Alanine aminotransferase increased | 2 (6%) | 0 | 2 (3%) | 1 (3%) | 0 |
| Lymphopenia | 2 (6%) | 0 | 2 (3%) | 1 (3%) | 0 |
| Neutropenia | 1 (3%) | 1 (3%) | 2 (3%) | 0 | 1 (3%) |
| Vertigo | 2 (6%) | 0 | 2 (3%) | 1 (3%) | 0 |
| Febrile neutropenia | 0 | 1 (3%) | 1 (1%) | 0 | 1 (3%) |
| Hyponatremia | 0 | 1 (3%) | 1 (1%) | 0 | 1 (3%) |
| Neutrophil count decreased | 0 | 1 (3%) | 1 (1%) | 0 | 1 (3%) |
| Renal failure, acute | 1 (3%) | 0 | 1 (1%) | 1 (3%) | 0 |
| AE MedDRA preferred term . | Related AEs . | Grade 3 or 4–related AEs . | |||
|---|---|---|---|---|---|
| Schedule A* (n = 32) . | Schedule B* (n = 36) . | All patients N = 68 . | Schedule A* (N = 32) . | Schedule B† (N = 36) . | |
| Patients with ≥1 related AE, n (%) | 28 (88%) | 36 (100%) | 64 (94%) | 0 | 0 |
| Fatigue | 13 (41%) | 19 (53%) | 32 (47%) | 2 (6%) | 2 (6%) |
| Headache | 11 (34%) | 18 (50%) | 29 (43%) | 0 | 0 |
| Nausea | 13 (41%) | 13 (36%) | 26 (38%) | 1 (3%) | 1 (3%) |
| Diarrhea | 8 (25%) | 11 (31%) | 19 (28%) | 1 (3%) | 0 |
| Dizziness | 9 (28%) | 9 (25%) | 18 (27%) | 1 (3%) | 0 |
| Vomiting | 10 (31%) | 7 (19%) | 17 (25%) | 1 (3%) | 1 (3%) |
| Hallucination | 4 (13%) | 4 (11%) | 8 (12%) | 0 | 0 |
| Decreased appetite | 2 (6%) | 6 (17%) | 8 (12%) | 0 | 0 |
| Anorexia | 5 (16%) | 2 (6%) | 7 (10%) | 0 | 0 |
| Confusional state | 2 (6%) | 5 (14%) | 7 (10%) | 1 (3%) | 1 (3%)‡ |
| Constipation | 4 (13%) | 3 (8%) | 7 (10%) | 0 | 0 |
| Insomnia | 4 (13%) | 3 (8%) | 7 (10%) | 0 | 1 (3%) |
| Anemia | 2 (6%) | 4 (11%) | 6 (9%) | 1 (3%) | 1 (3%) |
| Blood creatinine increased | 2 (6%) | 4 (11%) | 6 (9%) | 1 (3%)‡ | 1 (3%) |
| Dyspnea | 2 (6%) | 4 (11%) | 6 (9%) | 0 | 0 |
| Neuropathy peripheral | 1 (3%) | 5 (14%) | 6 (9%) | 0 | 1 (3%) |
| Asthenia | 1 (3%) | 4 (11%) | 5 (7%) | 0 | 0 |
| Gait disturbance | 1 (3%) | 4 (11%) | 5 (7%) | 0 | 0 |
| Pain in extremity | 1 (3%) | 4 (11%) | 4 (6%) | 0 | 0 |
| Mental status changes | 3 (9%) | 2 (6%) | 5 (7%) | 1 (3%) | 0 |
| Thrombocytopenia | 2 (6%) | 3 (8%) | 5 (7%) | 1 (3%) | 3 (8%) |
| Balance disorder | 1 (3%) | 3 (8%) | 4 (6%) | 1 (3%) | 0 |
| Alanine aminotransferase increased | 2 (6%) | 0 | 2 (3%) | 1 (3%) | 0 |
| Lymphopenia | 2 (6%) | 0 | 2 (3%) | 1 (3%) | 0 |
| Neutropenia | 1 (3%) | 1 (3%) | 2 (3%) | 0 | 1 (3%) |
| Vertigo | 2 (6%) | 0 | 2 (3%) | 1 (3%) | 0 |
| Febrile neutropenia | 0 | 1 (3%) | 1 (1%) | 0 | 1 (3%) |
| Hyponatremia | 0 | 1 (3%) | 1 (1%) | 0 | 1 (3%) |
| Neutrophil count decreased | 0 | 1 (3%) | 1 (1%) | 0 | 1 (3%) |
| Renal failure, acute | 1 (3%) | 0 | 1 (1%) | 1 (3%) | 0 |
Patients reporting more than one AE were counted once.
MedDRA, Medical Dictionary for Regulatory Activities v8.1.
Schedule A dosing was once weekly (days 1, 8, and 15 of 4-week cycles).
Schedule B dosing was twice weekly (days 1, 4, 8, and 11 of 3-week cycles); schedule B patients could receive low-dose Dex.
Grade 4 event.