| |
Patients <18 years N (%), E* |
Patients ≥ 18 years N (%), E* |
Total patients N (%), E* |
| All Patients |
797 |
964 |
1,761 |
| Patients with ADRs# |
|
|
|
| After first administration under medical supervision |
165 (20.7), 238 |
168 (17.4), 307 |
333 (18.9), 545 |
| On day 1 of treatment |
194 (24.3), 337 |
186 (19.3), 378 |
380 (21.6), 715 |
| ≥ day 2 of treatment |
147 (20.7), 335 |
112 (14.0), 259 |
259 (17.1), 593 |
| In the entire treatment period |
297 (37.3), 672 |
263 (27.3), 636 |
560 (31.8), 1,308 |
| Intensity |
|
|
|
| Mild |
149 (18.7) 312 |
100 (10.4), 258 |
249 (14.1), 570 |
| Moderate |
94 (11.8), 225 |
94 (9.8), 227 |
188 (10.7), 452 |
| Severe |
51 (6.4), 121 |
67 (7.0), 149 |
118 (6.7), 270 |
| Missing values |
3 (0.4), 14 |
2 (0.2), 2 |
5 (0.3), 16 |
| Serious |
1 (0.1), 3 |
5 (0.5), 12 |
6 (0.3), 15 |
| Treated by medication |
76 (9.5), 181 |
75 (7.8), 172 |
151 (8.6), 353 |
| Treatment terminated |
72 (9.0), 164 |
71 (7.4), 158 |
143 (8.1), 322 |
*E: Number of Events; #ADR: Adverse Drug Reaction |
