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Table 2 Treatment-related NCI CTCAE Version 3.0 Grade 3 or 4 treatment-emergent adverse events

From: A phase 1b study of humanized KS-interleukin-2 (huKS-IL2) immunocytokine with cyclophosphamide in patients with EpCAM-positive advanced solid tumors

System organ class, n (%)

huKS-IL2 dosing cohort, mg/m2

Total (n = 27)

0.5

1.0

2.0

3.0

4.0

(n = 3)

(n = 4)

(n = 7)

(n = 6)

(n = 7)

Any treatment-related TEAE of NCI CTCAE Grade 3 or 4

2 (67)

0

2 (29)

2 (33)

5 (71)

11 (41)

Blood/lymphatic system disorders

      

 Lymphopenia

1 (33)

0

1 (14)

2 (33)

1 (14)

5 (19)

 Anemia

0

0

0

0

1 (14)

1 (4)

 Neutropenia

0

0

0

0

1 (14)

1 (4)

 Thrombocytopenia

0

0

0

0

1 (14)

1 (4)

 WBC count decreased

0

0

0

0

1 (14)

1 (4)

Investigations

      

 Blood phosphorus equivalents increased

0

0

0

0

1(14)

1 (4)

 GGT increased

0

0

0

1 (17)

0

1 (4)

Gastrointestinal disorders

      

 Ascites

1 (33)

0

0

0

0

1 (4)

 Nausea

0

0

0

0

1 (14)

1 (4)

 Vomiting

0

0

0

0

1 (14)

1 (4)

Metabolism/nutrition disorders

      

 Hypophosphatemia

0

0

1 (14)

0

1 (14)

2 (7)

Respiratory/thoracic/mediastinal disorders

      

 Dyspnea

0

0

0

1 (17)

0

1 (4)

 Bronchospasm

0

0

0

1 (17)

0

1 (4)

 Hypoxia

0

0

1 (14)

0

0

1 (4)

  1. CTCAE, Common Terminology Criteria for Adverse Events; GGT, gamma-glutamyltransferase; huKS-IL2, humanized KS-interleukin-2; NCI, National Cancer Institute; TEAE, treatment-emergent adverse event; WBC, white blood cell.