Table 4.
Hematologic and nonhematologic adverse events occurring at toxicity grade 3 or 4 in ≥5% of patients by preferred term (ITT population)
| Preferred term* | Patients (N = 25), n (%) | |
|---|---|---|
| Grade 3 | Grade 4 | |
| Hematologic toxicities | ||
| Febrile neutropenia | 15 (60) | 2 (8) |
| Anemia | 14 (56) | 0 (0) |
| Neutropenia | 4 (16) | 7 (28) |
| Leukopenia | 1 (4) | 13 (52) |
| Lymphopenia | 0 (0) | 2 (8) |
| Thrombocytopenia | 0 (0) | 18 (72) |
| Nonhematologic toxicities | ||
| Diarrhea | 10 (40) | 0 (0) |
| Hypophosphatemia | 6 (24) | 0 (0) |
| Hypocalcemia | 4 (16) | 1 (4) |
| Graft-versus-host disease | 3 (12) | 0 (0) |
| Hypokalemia | 3 (12) | 0 (0) |
| Rash | 3 (12) | 0 (0) |
| Stomatitis | 3 (12) | 0 (0) |
| Abdominal pain | 2 (8) | 0 (0) |
| Fatigue | 2 (8) | 0 (0) |
| Hyponatremia | 2 (8) | 0 (0) |
| Hypoxia | 2 (8) | 0 (0) |
| Mucosal inflammation | 2 (8) | 0 (0) |
| Neutropenic colitis | 2 (8) | 0 (0) |
| Nausea | 2 (8) | 0 (0) |
| Esophagitis | 2 (8) | 0 (0) |
| Pain in extremity | 2 (8) | 0 (0) |
| Atrial fibrillation | 1 (4) | 1 (4) |
| Hypotension | 1 (4) | 1 (4) |
| Pneumonitis | 1 (4) | 1 (4) |
Patients were counted once for each preferred term.
Observation period: administration of high-dose melphalan at day –2 to end of intervention phase. AEs were coded using MedDRA Version 20.0. Definition of hematologic/nonhematologic AE terms are provided in Table 3.
*
AE data are listed in descending order of frequency of grade 3 events.