Table 4.
Grade 3/4 adverse events according to dose level and nephrectomy
| Dose level 1 | Dose level 2 | All N = 25 |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Nephrec-tomized N = 4 |
Non nephrec-tomized N = 11 |
All N = 15 |
Nephrec-tomized N = 3 |
Non nephrec-tomized N = 7 |
All N = 10 |
|||||
| N | N | N | % | N | N | N | % | N | % | |
| Thrombotic microangiopathy (TMA) | 0 | 2 | 2 | 13.3 | 1 | 1 | 2 | 20.0 | 4 | 16.0 |
| Thrombocytopenia | 0 | 2 | 2 | 13.3 | 0 | 1 | 1 | 10.0 | 3 | 12.0 |
| Elevated ALT and/or AST | 0 | 1 | 1 | 6.7 | 1 | 1 | 2 | 20.0 | 3 | 12.0 |
| Abdominal pain | 0 | 1 | 1 | 6.7 | 0 | 1 | 1 | 10.0 | 2 | 8.0 |
| Thoracic musculoskeletal pain | 0 | 2 | 2 | 13.3 | 0 | 0 | 0 | 0.0 | 2 | 8.0 |
| Hypertension | 0 | 0 | 0 | 0.0 | 1 | 1 | 2 | 20.0 | 2 | 8.0 |
| Proteinuria | 1 | 0 | 1 | 6.7 | 0 | 1 | 1 | 10.0 | 2 | 8.0 |
| Perianal abscess | 1 | 0 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
| Seizure | 0 | 1 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
| Diarrhea | 0 | 0 | 0 | 0.0 | 0 | 1 | 1 | 10.0 | 1 | 4.0 |
| Confusiona | 0 | 1 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
| Fatigue | 0 | 1 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
| Hypernatremia | 0 | 0 | 0 | 0.0 | 1 | 0 | 1 | 10.0 | 1 | 4.0 |
| Post-surgery bleeding | 0 | 0 | 0 | 0.0 | 1 | 0 | 1 | 10.0 | 1 | 4.0 |
| Lipase increase | 0 | 0 | 0 | 0.0 | 1 | 0 | 1 | 10.0 | 1 | 4.0 |
| Pyelonephritis | 0 | 1 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
| Hand & foot syndrome | 1 | 0 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
| Venous thrombosis | 0 | 0 | 0 | 0.0 | 1 | 0 | 1 | 10.0 | 1 | 4.0 |
| Vomiting | 0 | 1 | 1 | 6.7 | 0 | 0 | 0 | 0.0 | 1 | 4.0 |
aGrade 4 adverse event