Table 2:
Treatment related grade 3 and greater toxicities
| Adverse Event N(%)* | Stratum 1** (15 patients) | Stratum 2*** (36 patients) |
|---|---|---|
| No adverse events | 4 (26.7) | 3 (8.3) |
| Anemia | 4 (26.7) | 3 (8.3) |
| Febrile neutropenia | 0 | 1 (2.8) |
| Nausea | 0 | 2 (5.6) |
| Vomiting | 0 | 1 (2.8) |
| Fever | 2 (13.3) | 11 (30.6) |
| Pain | 3 (20.0) | 14 (38.9) |
| Allergic reaction | 0 | 2 (5.6) |
| Catheter related infection | 0 | 2 (5.6) |
| Enterocolitis infectious | 1 (6.7) | 0 |
| Infections and infestations – Other, specify | 1 (6.7) | 1 (2.8) |
| Lung infection | 0 | 1 (2.8) |
| Upper respiratory infection | 0 | 1 (2.8) |
| Alanine aminotransferase increased | 0 | 12 (33.3) |
| Aspartate aminotransferase increased | 0 | 9 (25.0) |
| Blood bilirubin increased | 5 (33.3) | 9 (25.0) |
| GGT increased | 0 | 3 (8.3) |
| Lymphocyte count decreased | 1 (6.7) | 7 (19.4) |
| Neutrophil count decreased | 0 | 4 (11.1) |
| White blood cell decreased | 1 (6.7) | 2 (5.6) |
| Platelet count decreased | 3 (20.0) | 8 (22.2) |
| Weight gain | 0 | 1 (2.8) |
| Anorexia | 0 | 2 (5.6) |
| Dehydration | 0 | 1 (2.8) |
| Hypercalcemia | 1 (6.7) | 0 |
| Hyperglycemia | 3 (20.0) | 2 (5.6) |
| Hypertriglyceridemia | 0 | 1 (2.8) |
| Hypoalbuminemia | 1 (6.7) | 1 (2.8) |
| Hypocalcemia | 1 (6.7) | 3 (8.3) |
| Hypokalemia | 3 (20.0) | 5 (13.9) |
| Hyponatremia | 1 (6.7) | 0 |
| Hypophosphatemia | 2 (13.3) | 3 (8.3) |
| Depressed level of consciousness | 0 | 1 (2.8) |
| Hypoxia | 2 (13.3) | 4 (11.1) |
| Pleural effusion | 2 (13.3) | 0 |
| Pneumonitis | 0 | 1 (2.8) |
| Respiratory failure | 0 | 1 (2.8) |
| Erythroderma | 0 | 1 (2.8) |
| Pruritus | 0 | 1 (2.8) |
| Rash maculo-papular | 1 (6.7) | 2 (5.6) |
| Hypotension | 2 (13.3) | 4 (11.1) |
| Capillary leak syndrome | 4 (26.7) | 4 (11.1) |
*
N = number of unique subjects experiencing a specific toxicity (% of stratum)
**
Disease measurable by standard radiographic criteria
***
Disease evaluable only by MIBG and/or bone marrow histology