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. Author manuscript; available in PMC: 2020 Apr 15.
Published in final edited form as: Clin Cancer Res. 2019 Jul 29;25(20):6044–6051. doi: 10.1158/1078-0432.CCR-19-0798

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