Table 2.
Breakdown of test set report statistics
| Data type | PM | SD | ML |
|---|---|---|---|
| Total number of reports | 1324 | 1045 | 347 |
| AE seriousness pairs, serious/non-seriousa | 763/1565 | 2615/660 | 811/668 |
| By seriousness classification | |||
| Hospitalization | 207 | 1837 | 184 |
| Important medical event | 485 | 330 | 507 |
| Death | 71 | 448 | 120 |
| Disability | 0 | 0 | 0 |
| Congenital anomaly | 0 | 0 | 0 |
| Required intervention (devices) | 0 | 0 | 0 |
| Life threatening | 0 | 0 | 0 |
AE adverse event, ML medical literature, PM spontaneous reports, SD solicited reports
aCalculated using the Medical Dictionary for Regulatory Activities code