Table 4.
Results from the initial manual assessment: Number of assessed and categorised drug‐event pairs by paediatric age group
| Assessed Drug‐Event Report Series | Neonates (n = 13) | Infants (n = 37) | Children (n = 217) | Adolescents (n = 205) | All Paediatric Ages (n = 472) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. | % | No. | % | No. | % | No. | % | No. | % | |
| Knowna | 2 | 15 | 11 | 30 | 131 | 60 | 147 | 72 | 291 | 62 |
| Nonsignalb | 11 | 85 | 26 | 70 | 68 | 31 | 47 | 23 | 152 | 32 |
| Keep under reviewc | 0 | ‐ | 0 | ‐ | 1 | 0.5 | 1 | 0.5 | 2 | 0.4 |
| Potential signald | 0 | ‐ | 0 | ‐ | 17 | 7.8 | 10 | 4.9 | 27 | 5.7 |
a
Considered well‐described for the specific age group in the product information.
b
Reports suggested alternative for more likely explanations for the event, such as coreported drugs, or lacked sufficient/relevant data for assessment.
c
Indicated potential signal but required time to gather more/better documented reports.
d
Required further in‐depth manual assessment.