Table 2.
(A) Severe adverse events (SAEs) that were deemed to be at least possibly TNFerade treatment related (Grades 3–5). (B) Severe toxicities deemed unrelated to TNFerade (related to chemoradiation or unrelated complications)
| (A) | |||
| Dose level 1: N = 6 (4 × 109) | Grade 3 | Grade 4 | Grade 5 |
| Thrombosis | 1 | 0 | 0 |
| Dose level 2: N = 3 (4 × 1010) | |||
| none | |||
| Dose level 3: N = 5 (4 × 1011) | |||
| Thrombosis | 2 | 0 | 0 |
| Pulmonary Embolism | 0 | 1 | 0 |
| Thrombocytopenia | 0 | 1 | 0 |
| (B) | |||
| Dose level 1: N = 6 (4 × 109) | |||
| Hyponatremia | 0 | 1 | 0 |
| Pneumothorax (spontaneous) | 0 | 1 | 0 |
| Constipation | 2 | 0 | 0 |
| Altered mental status | 1 | 0 | 0 |
| Hypoxic encephalopathy | 0 | 0 | 1 |
| Fever | 1 | 0 | 0 |
| Cellulitis | 1 | 0 | 0 |
| Respiratory alkalosis | 0 | 1 | 0 |
| Pneumonia | 5 | 0 | 0 |
| Mucositis | 5 | 0 | 0 |
| Dermatitis | 3 | 0 | 0 |
| Anemia | 2 | 0 | 0 |
| Hand foot syndrome | 1 | 0 | 0 |
| Neutropenia | 1 | 0 | 0 |
| Neuropathy | 1 | 0 | 0 |
| Low glucose | 1 | 0 | 0 |
| Elevated glucose | 1 | 0 | 0 |
| Sentinal bleed | 0 | 1 | 0 |
| Dose level 2: N = 3 (4 × 1010) | |||
| Bacteremia | 1 | 0 | 0 |
| Abscess | 1 | 0 | 0 |
| Pneumonia | 1 | 0 | 0 |
| Elevated liver enzymes | 3 | 0 | 0 |
| Mucositis | 3 | 0 | 0 |
| Dermatitis | 1 | 0 | 0 |
| Anemia | 0 | 0 | 0 |
| Hand foot syndrome | 1 | 0 | 0 |
| Neutropenia | 0 | 1 | 0 |
| Neuropathy | 1 | 0 | 0 |
| Elevated glucose | 1 | 0 | 0 |
| Dose level 3: N = 5 (4 × 1011) | |||
| Neutropenia | 0 | 1 | 0 |
| Pneumonia | 2 | 0 | 0 |
| Hypoxia | 1 | 0 | 0 |
| Acute renal failure | 1 | 0 | 0 |
| Cellulitis | 1 | 0 | 0 |
| Hyperkalemia | 1 | 0 | 0 |
| Fever | 3 | 0 | 0 |
| Altered mental status | 1 | 0 | 0 |
| Thrombocytopenia | 1 | 0 | 0 |
| Mucositis | 3 | 0 | 0 |
| Dermatitis | 1 | 0 | 0 |
| Hand foot syndrome | 1 | 0 | 0 |
| Cough | 1 | 0 | 0 |