TABLE 4.
Number and proportion of reports on severity and effect of ADRs.
| Result | Total N (%) | mAbs No. (%) | Non-mAb No. (%) | p value a |
|---|---|---|---|---|
| Total | 15,910 (100) | 575 (3.61) | 15,335 (96.39) | |
| Severity | ||||
| Serious | 5,459 (34.31) | 174 (30.26) | 5,285 (34.46) | 0.037 |
| Non-serious | 10,451 (65.69) | 401 (69.74) | 10,050 (65.54) | |
| Impact on the primary disease | ||||
| No effect | 13,260 (83.34) | 506 (88.00) | 12,754 (83.17) | <0.01 b |
| Prolong | 133 (0.84) | 10 (1.74) | 123 (0.80) | |
| Worse | 2,499 (15.71) | 58 (10.09) | 2,441 (15.92) | |
| Left with sequelae | 14 (0.09) | 1 (0.17) | 13 (0.08) | |
| Death | 4 (0.03) | 0 (0) | 4 (0.03) |
a
Chi-squared test.
b
Fisher exact test.