Table 4.
TEAEs occurring in 20% or more patients (safety analysis cohort)
| Preferred term, n (%) | Part 1 |
Patients treated at RP2D from part 1 and part 2 |
|
|---|---|---|---|
| Defibrotide 2.5 mg/kg (n = 4) |
Defibrotide 6.25 mg/kg (n = 6) |
Defibrotide 6.25 mg/kg (n = 21) |
|
| Patients with ≥1 TEAE∗ | 4 (100) | 6 (100) | 21 (100) |
| Pyrexia | 3 (75) | 5 (83) | 17 (81) |
| CRS | 3 (75) | 6 (100) | 16 (76) |
| Hypotension | 2 (50) | 6 (100) | 14 (67) |
| Nausea | 3 (75) | 3 (50) | 14 (67) |
| Diarrhea | 3 (75) | 4 (67) | 12 (57) |
| Fatigue | 1 (25) | 2 (33) | 12 (57) |
| Constipation | 2 (50) | 3 (50) | 11 (52) |
| Tremor | 1 (25) | 4 (67) | 11 (52) |
| Chills | 2 (50) | 5 (83) | 10 (48) |
| Headache | 2 (50) | 1 (17) | 10 (48) |
| Neutropenia | 1 (25) | 5 (83) | 10 (48) |
| Neurotoxicity | 0 | 4 (67) | 9 (43) |
| Decreased appetite | 1 (25) | 2 (33) | 8 (38) |
| Confusional state | 2 (50) | 3 (50) | 7 (33) |
| Febrile neutropenia | 1 (25) | 5 (83) | 7 (33) |
| Hypoxia | 2 (50) | 3 (50) | 7 (33) |
| Anemia | 1 (25) | 4 (67) | 6 (29) |
| Dizziness | 1 (25) | 2 (33) | 6 (29) |
| Hypocalcemia | 1 (25) | 2 (33) | 6 (29) |
| Hypomagnesemia | 0 | 3 (50) | 6 (29) |
| Sinus tachycardia | 0 | 2 (33) | 6 (29) |
| Back pain | 0 | 2 (33) | 5 (24) |
| Hypophosphatemia | 2 (50) | 1 (17) | 5 (24) |
| Edema peripheral | 1 (25) | 1 (17) | 5 (24) |
| Oropharyngeal pain | 0 | 1 (17) | 5 (24) |
| Urinary incontinence | 1 (25) | 3 (50) | 5 (24) |
| Vomiting | 1 (25) | 3 (50) | 5 (24) |
∗
Preferred terms are sorted in descending order of incident based on phase 2.