NIZ985 0.25 µg/kg n=1 | NIZ985 0.5 µg/kg n=2 | NIZ985 1.0 µg/kg n=6 | NIZ985 2.0 µg/kg n=3 | NIZ985 4.0 µg/kg n=2 | All NIZ98 patients N=14 | |
Treatment-related events | ||||||
Any event | 1 (100) | 2 (100) | 6 (100) | 3 (100) | 2 (100) | 14 (100) |
Grade 3–4 events | 0 | 1 (50.0)* | 2 (33.3)† | 1 (33.3)‡ | 2 (100)§ | 6 (42.9) |
Common treatment-related events (>20% in all patients) | ||||||
ISR | 1 (100) | 2 (100) | 6 (100) | 3 (100) | 2 (100) | 14 (100) |
Chills | 0 | 1 (50.0) | 4 (66.7) | 3 (100) | 2 (100) | 10 (71.4) |
Fatigue | 0 | 1 (50.0) | 4 (66.7) | 3 (100) | 0 | 8 (57.1) |
Fever | 0 | 1 (50.0) | 4 (66.7) | 2 (66.7) | 0 | 7 (50.0) |
Arthralgia | 0 | 2 (100) | 2 (33.3) | 1 (33.3) | 0 | 5 (35.7) |
Nausea | 0 | 1 (50.0) | 2 (33.3) | 1 (33.3) | 1 (50.0) | 5 (35.7) |
Hyperhidrosis | 0 | 0 | 2 (33.3) | 2 (66.7) | 0 | 4 (28.6) |
Decreased appetite | 0 | 0 | 2 (33.3) | 1 (33.3) | 0 | 3 (21.4) |
Constipation | 0 | 0 | 1 (16.7) | 2 (66.7) | 0 | 3 (21.4) |
Cognitive disorder | 0 | 1 (50.0) | 1 (16.7) | 0 | 1 (50.0) | 3 (21.4) |
Serious adverse events | ||||||
Any SAE | 0 | 0 | 0 | 2 (66.7) | 1 (50.0) | 3 (21.4) |
Acute kidney Injury | 0 | 0 | 0 | 0 | 1 (50.0) | 1 (7.1) |
Oliguria | 0 | 0 | 0 | 0 | 1 (50.0) | 1 (7.1) |
Dermatitis bullous | 0 | 0 | 0 | 1 (33.3) | 0 | 1 (7.1) |
Purpura | 0 | 0 | 0 | 1 (33.3) | 0 | 1 (7.1) |
Embolism | 0 | 0 | 0 | 0 | 1 (50.0) | 1 (7.1) |
Vasculitis | 0 | 0 | 0 | 0 | 1 (50.0) | 1 (7.1) |
*Grade 3 anemia.
†Grade 3 ISR (misclassified; subsequently reviewed and reclassified as grade 2) and grade 3 diarrhea.
‡Grade 3 increase in international normalized ratio.
§Grade 3 hyponatremia (one patient); grade 3 lymphocyte count decreases (two events), peripheral edema, purpura, and oliguria, plus grade 3 and 4 events of embolism, acute kidney injury, and vasculitis (one patient).
ISR, injection site reaction; SAE, serious adverse event.