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Table 2 Follow-up data

From: Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

 

Subcutaneous group (n = 115)

Intramuscular group (n = 92)

95% confidence interval of the difference

Mean circumference of the arm (SD), cm, 24 h

32,1 (3,4)

32,2 (4,2)

 

Mean change circumference of the arm (SD), cm, 24 h

+0,20 (1,44)

+0,28 (0,91)

-0,40 to +0,25 *

Patients with increase of the circumference of the arm >= 1 cm, n (%), 24 h

27 (23,5%)

18 (19,6%)

-7,3% to +15,1%

   Patients with skin lesions in the administration area, n (%), 24 h

43 (37,4%)

16 (17,4%)

+8,2% to +31,8%

   Erythema, n

36

8

 

   Papule, n

0

3

 

   Plaque, n

7

5

 

   Nodule, n

0

2

 

   Cyst, n

0

0

 

   Vesicle, n

0

0

 

   Blister, n

0

0

 

   Ulcer, n

0

0

 

   Scab, n

0

2

 

   Haematoma, n

2

1

 

   Pruritus, n

4

2

 

   Insensitivity, n

1

0

 

Mean Visual Analog Pain Scale (SD), 24 h

0,43 (1,08)

0,29 (0,84)

-0,12 to 0,41 *

Patients with Visual Analog Pain Scale > 0, n (%), 24 h

23 (20,0%)

13 (14,1%)

-4,3% to +16,1%

Mean INR (SD), 24 h

2,28 (0,64)

2,30 (0,70)

 

Mean change INR (SD), 24 h

+0,04 (0,50)

-0,06 (0,55)

-0,04 to +0,25 *

Mean INR (SD), 10d

2,31 (0,67)

2,44 (0,95)

 

Mean change INR (SD), 10d

+0,08 (0,79)

+0,07 (0,93)

-0,24 to +0,24 *

  1. *Calculated under the checked assumption of variance homogeneity of both samples.