Table A3.
Incidence of Grade 3 to 4 Treatment-Related Adverse Events Ordered by Frequency of Occurrence Among Patients on the SOC + TNFerade Arm
| Toxicity Type | SOC + TNFerade (n = 186) |
SOC (n = 91) |
||||||
|---|---|---|---|---|---|---|---|---|
| Grade 3 |
Grade 4 |
Grade 3 |
Grade 4 |
|||||
| No. | % | No. | % | No. | % | No. | % | |
| Lymphopenia | 26 | 13.98 | 8 | 4.30 | 9 | 9.89 | 2 | 2.20 |
| Abdominal pain/chest pain/back pain | 23 | 12.37 | 3 | 1.61 | 8 | 8.79 | 0 | 0 |
| Hypokalemia/hyperkalemia | 20 | 10.75 | 0 | 0 | 5 | 5.49 | 0 | 0 |
| Vomiting | 16 | 8.60 | 1 | 0.54 | 6 | 6.59 | 0 | 0 |
| Hyponatremia | 15 | 8.06 | 0 | 0 | 4 | 4.40 | 0 | 0 |
| Nausea | 13 | 6.99 | 0 | 0 | 3 | 3.30 | 0 | 0 |
| Bilirubin | 12 | 6.45 | 1 | 0.54 | 0 | 0 | 2 | 2.20 |
| Infection/bacteremia/sepsis | 12 | 6.45 | 1 | 0.54 | 3 | 3.30 | 0 | 0 |
| Anorexia | 11 | 5.91 | 0 | 0 | 3 | 3.30 | 0 | 0 |
| Biliary obstruction/cholangitis/jaundice | 11 | 5.91 | 6 | 3.23 | 8 | 8.79 | 0 | 0 |
| Dehydration | 11 | 5.91 | 0 | 0 | 0 | 0 | 1 | 1.10 |
| Anemia | 10 | 5.38 | 0 | 0 | 1 | 1.10 | 0 | 0 |
| Platelets/coagulopathy | 10 | 5.38 | 0 | 0 | 2 | 2.20 | 0 | 0 |
| Confusion/dizziness | 9 | 4.84 | 1 | 0.54 | 3 | 3.30 | 0 | 0 |
| Fatigue | 7 | 3.76 | 1 | 0.54 | 1 | 1.10 | 0 | 0 |
| GI obstruction/bleeding/abscess/hernia | 7 | 3.76 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hyperglycemia | 6 | 3.23 | 1 | 0.54 | 6 | 6.59 | 1 | 1.10 |
| Diarrhea/increased bowel movements | 5 | 2.69 | 0 | 0 | 4 | 4.40 | 0 | 0 |
| Hypophosphatemia | 5 | 2.69 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypoproteinemia/hyperproteinemia | 5 | 2.69 | 0 | 0 | 0 | 0 | 1 | 1.10 |
| Thrombosis/embolism | 5 | 2.69 | 3 | 1.61 | 1 | 1.10 | 1 | 1.10 |
| ALT | 4 | 2.15 | 0 | 0 | 0 | 0 | 0 | 0 |
| AST | 4 | 2.15 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fever | 4 | 2.15 | 1 | 0.54 | 1 | 1.10 | 0 | 0 |
| Liver function test/hepatic steatosis/diabetes | 4 | 2.15 | 2 | 1.08 | 1 | 1.10 | 0 | 0 |
| Fracture/injury/joint damage | 3 | 1.61 | 0 | 0 | 0 | 0 | 0 | 0 |
| Muscle weakness | 3 | 1.61 | 1 | 0.54 | 1 | 1.10 | 0 | 0 |
| Neutropenia | 3 | 1.61 | 0 | 0 | 1 | 1.10 | 0 | 0 |
| Renal complications | 3 | 1.61 | 0 | 0 | 1 | 1.10 | 0 | 0 |
| Weight loss | 3 | 1.61 | 0 | 0 | 1 | 1.10 | 0 | 0 |
| Alkaline phosphatase | 2 | 1.08 | 0 | 0 | 3 | 3.30 | 0 | 0 |
| Chills/sweats | 2 | 1.08 | 0 | 0 | 0 | 0 | 0 | 0 |
| Hypotension/hypertension | 2 | 1.08 | 0 | 0 | 0 | 0 | 0 | 0 |
| Leukopenia | 2 | 1.08 | 0 | 0 | 1 | 1.10 | 1 | 1.10 |
| Rash/pruritus | 2 | 1.08 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ascites | 1 | 0.54 | 0 | 0 | 2 | 2.20 | 0 | 0 |
| Infarction/hematoma/hemorrhage | 1 | 0.54 | 0 | 0 | 0 | 0 | 1 | 1.10 |
| Shortness of breath | 1 | 0.54 | 2 | 1.08 | 0 | 0 | 0 | 0 |
NOTE. Statistical comparison between standard of care (SOC) + TNFerade and SOC arms by Fisher's exact test yielded no significant differences in grade 3 or 4 toxicity based on a two-sided α level of .05.