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 3Grade 4
Hematologic toxicities
 Febrile neutropenia15 (60)2 (8)
 Anemia14 (56)0 (0)
 Neutropenia4 (16)7 (28)
 Leukopenia1 (4)13 (52)
 Lymphopenia0 (0)2 (8)
 Thrombocytopenia0 (0)18 (72)
Nonhematologic toxicities
 Diarrhea10 (40)0 (0)
 Hypophosphatemia6 (24)0 (0)
 Hypocalcemia4 (16)1 (4)
 Graft-versus-host disease3 (12)0 (0)
 Hypokalemia3 (12)0 (0)
 Rash3 (12)0 (0)
 Stomatitis3 (12)0 (0)
 Abdominal pain2 (8)0 (0)
 Fatigue2 (8)0 (0)
 Hyponatremia2 (8)0 (0)
 Hypoxia2 (8)0 (0)
 Mucosal inflammation2 (8)0 (0)
 Neutropenic colitis2 (8)0 (0)
 Nausea2 (8)0 (0)
 Esophagitis2 (8)0 (0)
 Pain in extremity2 (8)0 (0)
 Atrial fibrillation1 (4)1 (4)
 Hypotension1 (4)1 (4)
 Pneumonitis1 (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.