Table 1. Reported characteristics of the dataset.
| Complete dataset (n = 20,854) | |
|---|---|
| patients demographics | |
| mean age (median) | 8.5 years (9.0 years) |
| Female | 44.9% (n = 9,354) |
| Male | 51.2% (n = 10,670) |
| Unknown | 4.0% (n = 830) |
| seriousness criteria a | |
| Serious | 74.4% (n = 15,522) |
| Death | 2.9% (n = 604) |
| life-threatening | 6.6% (n = 1,374) |
| hospitalisation | 31.9% (n = 6,655) |
| Disabling | 1.7% (n = 358) |
| congenital anomaly | 5.5% (n = 1,140) |
| Unknown | 4.2% (n = 876) |
| primary source b | |
| HCP | 86.5% (n = 18,036) |
| Physician | 58.4% (n = 12,171) |
| Pharmacist | 9.4% (n = 1,959) |
| non-HCP | 12.2% (n = 2,546) |
| Consumer | 12.2% (n = 2,537) |
| Unspecified | 1.3% (n = 272) |
Table 1 shows an overview of the demographic parameters of the cases identified in EudraVigilance. In addition, seriousness and primary reporting sources for the reported cases were analysed.
a one ADR report may contain information about more than one seriousness criterion, therefore, the number of reported seriousness criteria exceeds the number of ADR reports.
b the term HCP summarizes all ADR reports in which a HCP (e.g. pharmacist, physician, other HCP) was involved in reporting the ADR. The term non-HCP summarizes all ADR reports in which only a non-HCP (e.g. consumer, lawyer, other non-HCP) was involved in reporting the ADR. Beyond that, Table 1 lists the number of reports which were only reported by physicians, pharmacists or consumers, respectively. The percentage determined refers to the share of the reporting source in the total number of all reports (20,854 reports).