Table 2.
All grade 3 and 4 toxicities by dose level
| Toxicity | N | ||||
|---|---|---|---|---|---|
| (patients) | 4 × 109PU | 4 × 1010PU | 4 × 1011PU | 1 × 1012PU | |
| GI bleeding | 6 | 1 | 3 | 0 | 2 |
| Deep vein thrombosis | 6 | 2 | 2 | 2 | 0 |
| Pulmonary embolism | 2 | 0 | 2 | 0 | 0 |
| Abdominal pain | 9 | 1 | 3 | 2 | 3 |
| Pancreatitis | 2* | 0 | 0 | 0 | 2 |
| Cholecystitis | 1 | 0 | 1 | 0 | 0 |
| Nausea,vomiting, anorexia | 4 | 1 | 3 | 0 | 0 |
| Biliary obstruction | 8 | 0 | 3 | 3 | 2 |
| Cholangitis | 6† | 0 | 3 | 2 | 1 |
| Anemia | 2 | 0 | 2 | 0 | 0 |
| Electrolyte abnormalities | 5 | 1 | 1 | 2 | 1 |
| Coagulopathy | 3 | 1 | 0 | 1 | 1 |
| Hypotension | 2‡ | 0 | 1 | 0 | 1 |
| Bradycardia | 1 | 0 | 0 | 0 | 1 |
| Supraventricular tachycardia | 1 | 1 | 0 | 0 | 0 |
| Intestinal ischemia | 1 | 1 | 0 | 0 | 0 |
| Staphylococcal infection | 1 | 1 | 0 | 0 | 0 |
| Mental status change | 1 | 0 | 1 | 0 | 0 |
| Cerebrovascular accident | 1 | 0 | 1 | 0 | 0 |
| Death | 2§ | 0 | 1 | 1 | 0 |
| Cardiopulmonary arrest | 1¶ | 0 | 0 | 1 | 0 |
PU, particle units.
*
Includes two DLTs at 1 × 1012 PU.
†
Includes one DLT at 1 × 1012 PU.
‡
Includes one DLT at 4 ×109 PU.
§
Two deaths unrelated to treatment.
¶
Cardiopulmonary arrest after pancreaticoduodenectomy surgery.