| 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 |