Table 1.
Distribution of SADR reports (n=1977) by patient age in Brazil between 2008-2013.
| Seriousness | Baby (aged 0 – 1 y) | Toddler(aged 1 - 3 y) | Preschool(aged 3 - 5 y) | Primary school (aged 5 - 8 y) | Secondary school (aged 8 - 12 y) | Total (%) |
|---|---|---|---|---|---|---|
| 1 – Death | 24 | 14 | 10 | 13 | 14 | 75 (4,0) |
| 2 - Life threatening | 102 | 36 | 26 | 19 | 33 | 216 (11,0) |
| 3 - Prolonged hospitalization | 65 | 61 | 44 | 28 | 65 | 263 (13,0) |
| 4 - Congenital abnormalities | 2 | 1 | 0 | 0 | 0 | 3 (0,2) |
| 5 - Persistent or significant disability | 4 | 3 | 9 | 4 | 7 | 27 (1,3) |
| 6 - Medically important events | 345 | 230 | 192 | 203 | 423 | 1393 (70,5) |
| Total | 542 | 345 | 281 | 267 | 542 | 1977 |
SADR, Serious Adverse Drug Reaction; y = year(s). Congenital abnormalities: SADR in children related to medicine use during the mother’s pregnancy. Source: Notivisa/Anvisa. P value < 0,001 (Chi Square test).