Table 2.
Patient characteristic | Patients with ADRs | ADRs | MDADsa | ADRs/MDADsa | ||
---|---|---|---|---|---|---|
N | % | N | % | N | ||
Gender | ||||||
Female | 2236 | 80.9 | 4567 | 82.9 | 2130 | 2.14 |
Male | 500 | 18.1 | 886 | 16.1 | 1542 | 0.57 |
Unknown | 29 | 1.0 | 53 | 1.0 | n.a.b | n.a.b |
Total | 2765 | 100 | 5506 | 100.0 | 3672 | 1.50 |
Age group | ||||||
Neonate (0–27 days) | 17 | 0.6 | 32 | 0.6 | 455c | 0.51c |
Infant (28 days–23 months) | 100 | 3.6 | 200 | 3.6 | ||
Child (2–11 years) | 141 | 5.1 | 234 | 4.2 | 1642 | 0.14 |
Adolescent (12–18 years) | 24 | 0.9 | 57 | 1.0 | 202 | 0.28 |
Adult (19–64 years) | 1477 | 53.4 | 3062 | 55.6 | 981 | 3.12 |
Elderly (≥ 65 years) | 550 | 19.9 | 1086 | 19.7 | 393 | 2.76 |
Unknown | 456 | 16.5 | 835 | 15.2 | n.a.b | n.a.b |
Total | 2765 | 100 | 5506 | 100.0 | 3672 | 1.50 |
MDADs maximum daily administration doses sold
a× 1 million
bn.a. not applicable, MDADs and Relative Frequency could not be calculated for unknown gender and age group
cMDADs and Relative Frequency for age group < 24 months