Table 3.
Characteristics of the assessed populations including seriousness of reported ADRs and occurrence of ADRs
| Studies by publication year | Study population (n) | Population age (years) | ADRs (n) | Prevalence of ADRs (%) | Incidence of ADRs (%) | ADRs by age groups (years) (%) | ADRs by male (%) | Serious ADRs (%) |
|---|---|---|---|---|---|---|---|---|
| McKenzie et al. (1973) [14] | 658 | ≤18 NS | 184 | 28 | 56 | <1: 22, 1–10: 52, >10: 26 | 58 | 23 |
| Whyte& Greenan (1977) [15] | 844 | ≤18 NS | 119 | 14 | 14 | NR | NR | 22 |
| Mitchell et al. (1979) [16] | 1 669 | ≤18 NS | 284 | 17 | 4 | <1: 23, 1–9: 52, >10: 66 | NR | NR |
| Choonara & Harris (1984) [17] | 268 | ≤12 | 17 | 6 | 13 | <1: 29, 1–10: 41, >10: 30 | NR | NR |
| Gill et al. (1995) [18] | 899 | ≤16 | 76 | 8 | 4 | NR | NR | 11 |
| Gonzalez-Martin et al. (1998) [19] | 219 | ≤16 | 46 | 21 | 21 | <1: 30, 1–9: 56, >10: 14 | NR | 28 |
| Martinez-Mir et al. (1999) [20] | 490 | ≤2 | 282 | 58 | 96 | NR | 37 | 7 |
| Turner et al. (1999) [21] | 936 | ≤18 | 157 | 17 | 67 | NR | NR | 11 |
| Buajordet et al. (2002) [22] | 579 | ≤16 | 414 | 72 | 179 | NR | NR | 19 |
| Temple et al. (2004) [23] | 65 864 | ≤18 NS | 565 | 1 | 1 | <2: 15, 2–9: 54, >10: 32 | NR | 43 |
| Haffner et al. (2005) [24] | 703 | ≤18 | 101 | 14 | 57 | <1: 18, 2–10: NR, >10: 6 | 58 | 31 |
| Le et al. (2006) [25] | NR | ≤18 NS | 1087 | NA | 2 | <1: 26, 1–10: 39, >10: 35 | 50 | 11 |
| Planchamp et al. (2009) [26] | 1 676 | <18 | 43 | 3 | 5 | NR | 56 | 33 |
| McKenzie et al. (1976) [27] | 3 556 | ≤18 NS | 72 | 2 | 1 | NR | NR | 44 |
| Yosselson-Superstine et al. (1982) [28] | 906 | ≤16 | 29 | 3 | 5 | <1: 10, 1–10: 69.5, >10: 6 | 57 | 45 |
| Mitchell et al. (1988) [29] | 10 297 | ≤18 NS | 131 | 1 | <1 | <1: 23, 1–9: 40, >10: 35 | NR | NR |
| Martinez-Mir et al. (1996) [30] | 490 | ≤2 | 42 | 9 | 14 | <1: 67, >1: 33 | 33 | 38 |
| Easton et al. (1998) [31] | 1 682 | ≤18 | 58 | 3 | 23 | NR | NR | 37 |
| Haffner et al. (2005) [24] | 636 | ≤18 | 45 | 7 | 28 | NR | 61 | 18 |
| Kramer et al. (1985) [32] | 3 181 | <19 | 200 | 6 | 6 | NR | NR | NR |
| Sanz & Boada (1987) [33] | 1 327 | ≤7 | 17 | 1 | 3 | <1: 29, >1: 71 | 20 | NR |
| Woods et al. (1987) [34] | 1 590 | 3–11 | 270 | 17 | 68 | NR | NR | 18 |
| Cirko-Begovic et al. (1989) [35] | 2 359 | ≤7 | 63 | 3 | 11 | NR | NR | NR |
| Menniti-Ippolito et al. (2000) [36] | 7 890 | ≤14 | 119 | 2 | 2 | <1: 13, 1–7: 65, 7–14: 22 | NR | 0 |
| Lewis et al. (2001) [37] | 12 628 | ≤16 | 152 | 1 | 5 | NR | NR | 17 |
| Horen et al. (2002) [38] | 1 419 | ≤15 | 20 | 1 | 6 | <1: 50, >1: 50 | 45 | 0 |
| Meyboom (1991) [39] | NR | ≤14 | 695 | NA | NA | NR | NR | NR |
| Morales-Olivas et al. (2000) [40] | NR | ≤14 | 2454 | NA | NA | <1: 13, 1–9: 63, >10: 24 | 55 | 5 |
| Moore et al. (2002) [41] | NR | ≤2 | 5976 | NA | NA | <1: 82, >1: 18 | 57 | 63 |
| Schirm et al. (2004) [42] | 57 034 | ≤16 | 773 | NA | 0.2 | <1: 20, 2–11: 52, >12: 28 | 47 | 7 |
| Ufer et al. (2004) [43] | 1 736 656 | ≤15 | 158 | 0.01 | 0.01 | <2: 14, 2–9: 52, >10: 34 | 56 | 31 |
| Kimland et al. (2005) [44] | 1 700 000 | ≤15 | 7887 | 0.5 | 0.03 | <4: 61, 5–9: 16, >10: 23 | 55 | 13 |
| Carleton et al. (2007) [45] | 7 670 000 | ≤19 | 1193 | 0.02 | <0.01 | <1: 12, 1–13: 28, >13: 59 | NR | 61 |
| Aagaard et al. (2010) [46] | 1 100 000 | ≤17 | 4500 | 0.4 | 0.04 | <2: 52, 2–10: 25, 11–17: 23 | 49 | 42 |
NA, not available; NR, not reported; NS, not specified.