Table 1.
Baseline characteristics.
| Pre-COVID (2000–Dec 2019) |
COVID (Jan–July 2020) |
|
|---|---|---|
| Number of case reports | 1629 | 192 |
| Number of ADRs | 2553 | 322 |
| Gendera,b | ||
| Ratio men/women | 0.71 | 0.64 |
| Age (years)a,c | ||
| Mean (± SD) | 42.4 (± 11.3) | 63.5 (± 24.2) |
| Median | 42 | 65 |
| Min–Max | 0.022–82 | 20–92 |
| ‘Pregnancy’ reports | ||
| n (%) | 56 | 0 |
| ‘Drug interaction’ reports | ||
| n (%) | 62 | 10 |
| Serious cases (%) | 571 (35%) | 114 (59%) |
| Seriousness criteria (WHO criteria) | ||
| Death | 31 (5.4%) | 4 (3.5%) |
| Life-threatening | 51 (8.9%) | 6 (5.3%) |
| Incapacity/disability | 22 (3.9%) | 0 |
| Birth defect | 7 (1.2%) | 0 |
| Hospitalization | 393 (68.8%) | 39 (34.2%) |
| Other | 67 (11.7%) | 65 (57%) |
ADRs: adverse drug reactions; COVID: coronavirus disease; WHO: World Health Organization.
a
Infants of pregnant cases were not included in the gender and age analysis.
b
Patient gender unknown for 10 patients of the pre-COVID period.
c
Patient age unknown for 18 patients of the pre-COVID period.