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Table 3 Frequent and Severe Adverse Events (CTCAE version 3.0)

From: A phase ΙI study of five peptides combination with oxaliplatin-based chemotherapy as a first-line therapy for advanced colorectal cancer (FXV study)

FOLFOX (n = 89), FOLFOX + Bev (n = 4), XELOX + Bev (n = 1)

 

HLA-A*2402-matched (n = 50)

HLA-A*2402-unmatched (n = 46)

FOLFOX (n = 48), XELOX (n = 2)

FOLFOX (n = 41) + Bev (n = 4), XELOX + Bev (n = 1)

Adverse Event

1

2

3

4

5

1

2

3

4

5

No

%

No

%

No

%

No

%

No

%

No

%

No

%

No

%

No

%

No

%

Hand-foot syndrome

0

0

0

0

1

2

0

0

0

0

1

2

0

0

1

2

0

0

0

0

Allergy

4

8

3

6

2

4

0

0

0

0

3

7

4

9

0

0

0

0

0

0

Mucositis

2

4

1

2

1

2

0

0

0

0

2

4

0

0

0

0

0

0

0

0

Nausea/vomiting

5

10

1

2

2

4

0

0

0

0

6

13

2

4

1

2

0

0

0

0

Neurologic toxicity

15

30

10

20

4

8

0

 

0

0

17

37

10

22

5

11

1

2

0

0

Anorexia

10

20

3

6

4

8

0

0

0

0

10

22

4

9

2

4

0

0

0

0

Diarrhea

3

6

6

12

2

4

0

0

0

0

3

7

0

0

1

2

0

0

0

0

Fatigue/Asthenia

5

10

1

2

2

4

0

0

0

0

5

11

1

2

1

2

0

0

0

0

Fever

2

4

0

0

0

0

0

0

0

0

3

7

2

4

0

0

0

0

0

0

Injection site reaction

18

36

18

36

9

18

0

0

0

0

20

43

17

37

3

13

0

0

0

0

Interstitial pneumonia

0

0

0

0

4

8

0

0

2

4

0

0

0

0

4

9

0

0

1

2

Neutropenia

5

10

10

20

10

20

1

2

0

0

8

17

14

30

2

4

1

2

0

0

Leukopenia

10

20

12

24

1

2

0

0

0

0

12

26

9

20

2

4

0

0

0

0

Thrombocytopenia

17

34

3

6

0

0

0

0

0

0

20

43

2

4

0

0

0

0

0

0

Bilirubin

2

4

2

4

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

AL-P

11

22

1

2

1

2

0

0

0

0

10

22

1

2

0

0

0

0

0

0

Creatinine

3

6

1

2

0

0

0

0

0

0

1

2

0

0

0

0

0

0

0

0

Hemoglobin

11

22

5

10

0

0

0

0

0

0

13

28

7

15

0

0

0

0

0

0

Embolism

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

2

0

0

AST/ALT

12

24

0

0

1

2

0

0

0

0

6

13

1

2

0

0

0

0

0

0

  1. No gastrointestinal perforation nor bleeding wound healing complication was observed. FOLFOX, infusional fluorouracil, leucovorin, and oxaliplatin; XELOX, capecitabine and oxaliplatin; Bev, bevacizumab; AL-P, alkaline phosphatese; AST, aspartete aminotransfarase; ALT, alanine aminotransferase; CTCAE, the Common Terminology Criteria for Adverse Event version 3.0; HLA, Human leukocyte antigen.