All Grade 3 or 4 AEs and additional AEs (all grades) occurring in more than 1 patient
| AE . | All grades . | Grade 3 or 4 . | ||||
|---|---|---|---|---|---|---|
| n . | % . | No. of events . | n . | % . | No. of events . | |
| Any AE | 21 | 100 | 132 | 7 | 33 | 18 |
| Infusion-related reactions | 18 | 86 | 48 | 2 | 10 | 3 |
| Cycle 1, day 1 (n = 21) | 17 | 81 | 1 | 5 | ||
| Cycle 1, day 8 (n = 20) | 8 | 40 | 1 | 5 | ||
| Cycle 2 (n = 19) | 5 | 26 | ||||
| Cycle 3 or later (n = 16) | 6 | 38 | ||||
| Infections* | 11 | 52 | 16 | |||
| Asthenia | 8 | 38 | 10 | 2 | 10 | 2 |
| Diarrhea | 5 | 24 | 7 | |||
| Thrombocytopenia | 4 | 19 | 4 | 1 | 5 | 1 |
| Anorexia | 4 | 19 | 4 | 1 | 5 | 1 |
| Weight loss | 4 | 19 | 4 | |||
| Lymphopenia | 3 | 14 | 3 | 3 | 14 | 3 |
| Fatigue | 3 | 14 | 3 | |||
| Nausea | 3 | 14 | 3 | |||
| Insomnia | 3 | 14 | 3 | |||
| Neutropenia | 2 | 10 | 2 | 2 | 10 | 2 |
| Anemia | 2 | 10 | 2 | 1 | 5 | 1 |
| Sciatica | 1 | 5 | 1 | 1 | 5 | 1 |
| Extrinsic vascular compression | 1 | 5 | 1 | 1 | 5 | 1 |
| Tumor lysis syndrome | 1 | 5 | 2 | 1 | 5 | 2 |
| Leukopenia | 1 | 5 | 1 | 1 | 5 | 1 |
| Axillary pain | 1 | 5 | 1 | 1 | 5 | 1 |
| Cerebrovascular accident† | 1 | 5 | 1 | |||
| AE . | All grades . | Grade 3 or 4 . | ||||
|---|---|---|---|---|---|---|
| n . | % . | No. of events . | n . | % . | No. of events . | |
| Any AE | 21 | 100 | 132 | 7 | 33 | 18 |
| Infusion-related reactions | 18 | 86 | 48 | 2 | 10 | 3 |
| Cycle 1, day 1 (n = 21) | 17 | 81 | 1 | 5 | ||
| Cycle 1, day 8 (n = 20) | 8 | 40 | 1 | 5 | ||
| Cycle 2 (n = 19) | 5 | 26 | ||||
| Cycle 3 or later (n = 16) | 6 | 38 | ||||
| Infections* | 11 | 52 | 16 | |||
| Asthenia | 8 | 38 | 10 | 2 | 10 | 2 |
| Diarrhea | 5 | 24 | 7 | |||
| Thrombocytopenia | 4 | 19 | 4 | 1 | 5 | 1 |
| Anorexia | 4 | 19 | 4 | 1 | 5 | 1 |
| Weight loss | 4 | 19 | 4 | |||
| Lymphopenia | 3 | 14 | 3 | 3 | 14 | 3 |
| Fatigue | 3 | 14 | 3 | |||
| Nausea | 3 | 14 | 3 | |||
| Insomnia | 3 | 14 | 3 | |||
| Neutropenia | 2 | 10 | 2 | 2 | 10 | 2 |
| Anemia | 2 | 10 | 2 | 1 | 5 | 1 |
| Sciatica | 1 | 5 | 1 | 1 | 5 | 1 |
| Extrinsic vascular compression | 1 | 5 | 1 | 1 | 5 | 1 |
| Tumor lysis syndrome | 1 | 5 | 2 | 1 | 5 | 2 |
| Leukopenia | 1 | 5 | 1 | 1 | 5 | 1 |
| Axillary pain | 1 | 5 | 1 | 1 | 5 | 1 |
| Cerebrovascular accident† | 1 | 5 | 1 | |||
The most common infection reported was bronchitis (n = 4). Herpesvirus infection occurred in 2 patients. All reported infections were grade 1 or 2.
The incidence of cerebrovascular accident was grade 5 and resulted in death. This 83-year-old patient had a low IgM level before treatment (115 mg/dL). IgM levels increased to 404 mg/dL after cycle 1, but returned to 107 mg/dL after cycle 2, 34 days before the cerebrovascular accident. Although no disease evaluation or IgM measurement was available before death, given this kinetic and the patient's underlying illness, the investigator judged that this event was unrelated to the study drug.