Table 4.
Treatment-related Adverse Events at the Patient Level
| Dose Level Toxicities/Grade | All Cycles | |||
|---|---|---|---|---|
| VOR(R)-EPOCH (300 mg) (n = 6) | VOR(R)-EPOCH (400 mg) (n = 6) | |||
| Grade ≤2 | Grade ≥3 | Grade ≤2 | Grade ≥3 | |
| Hematologic | ||||
| Anemia | 2 | 1 | 1 | 3 |
| Febrile neutropenia | n/a | 2 | n/a | 2 |
| Lymphopenia | 0 | 1 | 1 | 2 |
| Neutropenia | 1 | 3 | 0 | 4 |
| Thrombocytopenia | 2 | 2 | 1 | 3 |
| Non-hematologic | ||||
| Alopecia | 0 | 0 | 0 | 0 |
| Bone pain | 0 | 0 | 0 | 0 |
| Cardiac | 1 | 1 | 0 | 1 |
| Death-NOS | n/a | 1 | n/a | 0 |
| Dermatologic | 3 | 0 | 2 | 0 |
| Dyspnea | 0 | 0 | 0 | 0 |
| Eye disorders | 1 | 0 | 0 | 0 |
| Fatigue | 0 | 0 | 0 | 0 |
| Gastrointestinal | ||||
| Abdominal pain | 1 | 1 | 1 | 0 |
| Anal mucositis | 0 | 0 | 1 | 0 |
| Colitis | 0 | 1 | 0 | 0 |
| Constipation | 3 | 0 | 2 | 0 |
| Diarrhea | 1 | 2 | 1 | 0 |
| Dyspepsia | 1 | 0 | 0 | 0 |
| Esophagitis | 1 | 0 | 1 | 0 |
| Intra-abdominal hemorrhage | 0 | 1 | 0 | 0 |
| Muscositis oral | 1 | 0 | 2 | 0 |
| Nausea | 5 | 0 | 1 | 0 |
| Vomiting | 1 | 1 | 1 | 0 |
| Generalized symptoms | 4 | 0 | 5 | 1 |
| Hepatic | 1 | 1 | 1 | 1 |
| Infection | 2 | 4 | 2 | 0 |
| Infusion reaction | 1 | 0 | 0 | 0 |
| Metabolic | 4 | 1 | 5 | 1 |
| Musculoskeletal | 4 | 0 | 1 | 0 |
| Neurologic | 5 | 0 | 3 | 0 |
| Oligospermia | 0 | 0 | 0 | 0 |
| Paresthesia | 0 | 0 | 0 | 0 |
| Procedural complication | 0 | 1 | 0 | 0 |
| Psychiatric | 1 | 0 | 1 | 0 |
| Respiratory, thoracic, and mediastinal | 4 | 0 | 0 | 0 |
| Vascular | 3 | 0 | 0 | 0 |
Abbreviations: NOS = not otherwise specified; R = rituximab; VOR = vorinostat.