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Table 3 Systemic and local adverse events in 20 patients who received at least one vaccination

From: HPV16 synthetic long peptide (HPV16-SLP) vaccination therapy of patients with advanced or recurrent HPV16-induced gynecological carcinoma, a phase II trial

 

Patients (N = 20)

Vaccinations (N = 67)

 

CTCAE grade 1

CTCAE grade 2

CTCAE grade 3

CTCAE grade 1

CTCAE grade 2

CTCAE grade 3

 

<24 h

>24 h

total

<24 h

>24 h

total

<24 h

>24 h

total

<24 h

>24 h

total

<24 h

>24 h

total

<24 h

>24 h

total

Systemic adverse events

Fever

6 (30%)

1 (5%)

5 (25%)

2 (10%)

1 (5%)

3 (15%)

-

-

-

7 (10.5%)

1 (1.5%)

7 (10.5%)

3 (4.5%)

1 (1.5%)

4 (6%)

-

-

-

Chills/rigors

6 (30%)

1 (5%)

6 (30%)

-

-

-

-

-

-

10 (15%)

1 (1.5%)

11 (16.5%)

-

-

-

-

-

-

Myalgia (yes/no)

0 (0%)

1 (5%)

1 (5%)

-

-

-

-

-

-

0 (0%)

1 (1.5%)

1 (1.5%)

-

-

-

-

-

-

Fatigue

0 (0%)

1 (5%)

1 (5%)

2 (10%)

3 (15%)

3 (15%)

-

-

-

1 (1.5%)

4 (6%)

3 (4.5%)

4 (6%)

4 (6%)

6 (9%)

-

-

-

Nausea

6 (30%)

2 (10%)

6 (30%)

-

-

-

-

-

-

7 (10.5%)

3 (4.5%)

9 (13.5%)

-

-

-

-

-

-

Vomiting

2 (10%)

1 (5%)

2 (10%)

-

-

-

-

-

-

2 (3%)

2 (3%)

3 (4.5%)

-

-

-

-

-

-

Headache

-

-

-

1 (5%)

2 (10%)

2 (10%)

-

-

-

1 (1.5%)

1 (1.5%)

1 (1.5%)

2 (3%)

3 (4.5%)

3 (4.5%)

-

-

-

Rash/Generalised erythema

3 (15%)

1 (5%)

3 (15%)

1 (5%)

-

1 (4%)

-

-

-

5 (7.5%)

1 (1.5)

5 (7.5%)

1 (1.5%)

-

1 (1.5%)

-

-

-

Inability to concentrate (Y/N)

-

-

-

-

-

-

-

-

-

0 (0%)

0 (0%)

0 (0%)

-

-

-

-

-

-

Tingling extremities

1 (5%)

2 (10%)

2 (10%)

-

-

-

-

-

-

1 (1.5%)

0 (0%)

1 (1.5%)

-

-

-

-

-

-

Swelling extremities

2 (10%)

2 (10%)

4 (20%)

-

-

-

-

-

-

3 (4.5%)

2 (3%)

5 (7.5%)

-

-

-

-

-

-

Flu-like symptoms/Malaise

4 (20%)

3 (15%)

7 (35%)

-

-

-

-

-

-

5 (7.5%)

5 (7.5%)

10 (15%)

-

-

-

-

-

-

Local adverse events

Injection site reaction

  

0 (0%)

  

20 (100%)

  

0 (0%)

  

0 (0%)

  

67 (100%)

  

0(0%)

  1. The number of patients (and percentage) are depicted per catagory (systemically or locally) and grade of toxicity according to CTCAE version 3.
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Journal of Translational Medicine

ISSN: 1479-5876

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