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Table 2 Total number of medicine courses in each authorized, off-label or unlicensed category and number implicated in at least one PD ADR (n = 10,145)

From: Adverse drug reactions and off-label and unlicensed medicines in children: a nested case?control study of inpatients in a pediatric hospital

 

Categorya

Number of medicine courses

% of courses implicated in at least one PD ADR

Odds ratio of ADR versus authorized

95% CI

Off-label medicines

Medicines licensed for use in children

1

6,980

6.2

1.00

-

2

1

0

-

-

3

698

2.7

0.42

0.26 to 0.67

5

588

19.0

3.54

2.82 to 4.44

6

1

0

-

-

7

61

9.8

1.64

0.70 to 3.83

11

764

14.3

2.50

2.00 to 3.13

13

8

0

-

-

15

35

25.7

5.21

2.43 to 11.18

17

21

0

-

-

19

2

0

-

-

Medicines not licensed for use in children

21

215

18.6

3.44

2.41 to 4.91

22

1

100.0

-

-

23

1

0

-

-

25

11

18.2

3.34

0.72 to 15.52

Unlicensed medicines

31

143

14.7

2.59

1.61 to 4.16

32

577

14.9

2.64

2.05 to 3.38

33

1

0

-

-

34

37

16.2

2.91

1.21 to 7.02

  1. asee Table?1 for category definitions. PD ADR, probable or definite ADR; adverse drug reaction; CI, confidence interval.