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Table 2 Summary of adverse events

From: Phase I clinical study of multiple epitope peptide vaccine combined with chemoradiation therapy in esophageal cancer patients

Toxicity

Peptide

Total patients (n = 11)

0.5 mg (n = 3)

1.0 mg (n = 3)

3.0 mg (n = 5)

Grade*

Grade

Grade

Grade (%)

1

2

3

1

2

3

1

2

3

1

2

3

Dermatology/skin

            

  Reaction at the injection site

2

0

0

3

0

0

4

0

0

9 (81.8)

0 (0.0)

0 (0.0)

Hematological

            

  Leukocyte

0

0

2

0

0

2

0

1

2

0 (0.0)

1 (9.1)

6 (54.5)

  Neutrocyte

0

1

1

0

1

1

0

2

1

0 (0.0)

4 (36.4)

3 (27.3)

  Hemoglobin

1

1

1

1

1

1

1

1

1

3 (27.3)

3 (27.3)

3 (27.3)

  Platelet

1

0

0

0

0

1

3

0

0

4 (36.4)

0 (0.0)

1 (9.1)

Non-hematological

            

  Esophagitis

0

1

0

2

0

0

2

1

0

4 (36.4)

2 (18.2)

0 (0.0)

  AST

1

0

0

1

0

0

0

0

0

2 (18.2)

0 (0.0)

0 (0.0)

  ALT

0

0

0

0

0

0

1

0

0

1 (9.1)

0 (0.0)

0 (0.0)

  Creatinine

0

0

0

0

0

0

0

0

0

0 (0.0)

0 (0.0)

0 (0.0)

  Nausea/vomiting

1

0

0

0

1

0

0

0

0

1 (9.1)

2 (18.2)

0 (0.0)

  Diarrhea

0

1

0

0

0

0

0

0

0

0 (0.0)

1 (9.1)

0 (0.0)

Stomatitis/pharyngitis

0

1

0

0

1

0

0

1

0

0 (0.0)

3 (27.3)

0 (0.0)

  Hyponatremia

0

2

0

1

0

0

1

1

0

2 (18.2)

3 (27.3)

0 (0.0)

  1. *Adverse events were graded according to the CTCAE v3.0.