Event | Control ASCT (n=5) | IVTRD ASCT (n=4) | EVTRD ASCT (n=5) | |||
All grade | Grade 3 or 4 | All grade | Grade 3 or 4 | All grade | Grade 3 or 4 | |
Constitutional symptoms | ||||||
Fatigue | 4 (80%) | 1 (20%) | 0 | 0 | 0 | 0 |
Fever | 3 (60%) | 2 (40%) | 1 (25%) | 1 (25%) | 4 (80%) | 4 (80%) |
Pain | 2 (40%) | 0 | 1 (25%) | 0 | 1 (20%) | 0 |
Weight loss | 0 | 0 | 0 | 0 | 1 (20%) | 0 |
Malaise | 0 | 0 | 0 | 0 | 1 (20%) | 0 |
Gastrointestinal disorders | ||||||
Nausea | 2 (40%) | 0 | 1 (25%) | 0 | 1 (20%) | 0 |
Diarrhea | 1 (20%) | 0 | 1 (25%) | 0 | 1 (20%) | 0 |
Hepatobiliary disorders | ||||||
Increased aminotransferase level | 1 (20%) | 0 | 0 | 0 | 1 (20%) | 1 (20%) |
Hyperbilirubinemia | 1 (20%) | 1 (20%) | 0 | 0 | 1 (20%) | 0 |
Electrolyte disorders | ||||||
Hypocalcemia | 2 (40%) | 0 | 0 | 0 | 1 (20%) | 0 |
Hypokalemia | 1 (20%) | 0 | 1 (25%) | 0 | 2 (40%) | 1 (20%) |
Hypophosphatemia | 1 (20%) | 0 | 1 (25%) | 0 | 1 (20%) | 1 (20%) |
Miscellaneous | ||||||
Hyperglycemia | 2 (40%) | 1 (20%) | 1 (25%) | 0 | 2 (40%) | 1 (20%) |
Peripheral neuropathy | 1 (20%) | 0 | 1 (25%) | 0 | 0 | 0 |
Chronic kidney disease | 1 (20%) | 0 | 1 (25%) | 0 | 0 | 0 |
Bone fracture | 0 | 0 | 1 (25%) | 1 (25%) | 0 | 0 |
Rash | 0 | 0 | 0 | 0 | 1 (20%) | 1 (20%) |
Cough | 0 | 0 | 0 | 0 | 1 (20%) | 0 |
Lymphadenitis | 0 | 0 | 0 | 0 | 1 (20%) | 0 |
Hemorrhoids | 1 (20%) | 0 | 0 | 0 | 0 | 0 |
Shown are adverse events (irrespective of the relationship to the study drugs) that were reported in at least one patient.
ASCT, autologous stem cell transplant; EVTRD, ex vivo regulatory T-cell depletion; IVTRD, in vivo regulatory T-cell depletion.