Table 2.
Adverse events attributed to study treatment
| Grade 1-2, n (%) | Grade 3-4, n (%) | All grades, n (%) | |
|---|---|---|---|
| Hematologic adverse events | |||
| Lymphocyte count decreased* | 8 (66.7) | 2 (16.7) | 10 (83.3) |
| Neutrophil count decreased | 6 (50) | 4 (33.3) | 10 (83.3) |
| Platelet count decreased | 7 (58.3) | 2 (16.7) | 9 (75) |
| Anemia | 2 (16.7) | — | 2 (16.7) |
| Lymphocyte count increased* | — | 1 (8.3) | 1 (8.3) |
| Nonhematologic adverse events | |||
| Infusion related reaction | 9 (75) | 1 (8.3) | 10 (83.3) |
| Bruising | 9 (75) | — | 9 (75) |
| Diarrhea | 8 (66.7) | — | 8 (66.7) |
| Hypertension | 5 (41.7) | 3 (25) | 8 (66.7) |
| Myalgia | 7 (58.3) | — | 7 (58.3) |
| Arthralgia | 6 (50) | — | 6 (50) |
| Fatigue | 3 (25) | 2 (16.7) | 5 (41.7) |
| Hyperuricemia | 5 (41.7) | — | 5 (41.7) |
| Alanine aminotransferase increased | 4 (33.3) | — | 4 (33.3) |
| Aspartate aminotransferase increased | 4 (33.3) | — | 4 (33.3) |
| Dizziness | 4 (33.3) | — | 4 (33.3) |
| Epistaxis | 4 (33.3) | — | 4 (33.3) |
| Hypocalcemia | 4 (33.3) | — | 4 (33.3) |
| Nausea | 4 (33.3) | — | 4 (33.3) |
| Headache | 3 (25) | — | 3 (25) |
| Allergic rhinitis | 2 (16.7) | — | 2 (16.7) |
| Bullous dermatitis | 2 (16.7) | — | 2 (16.7) |
| Constipation | 2 (16.7) | — | 2 (16.7) |
| Dysgeusia | 2 (16.7) | — | 2 (16.7) |
| Dyspepsia | 2 (16.7) | — | 2 (16.7) |
| Dyspnea | 2 (16.7) | — | 2 (16.7) |
| Hyperhidrosis | 2 (16.7) | — | 2 (16.7) |
| Mucositis oral | 2 (16.7) | — | 2 (16.7) |
| Petechia | 2 (16.7) | — | 2 (16.7) |
| Rash maculo-papular | 2 (16.7) | — | 2 (16.7) |
Treatment-related adverse events occurring in more than 1 subject or grade 3 or greater.
*
Known therapeutic drug effect expected with treatment.