Table 4.
Comparison of the number of patients (incidence) who experienced major adverse reactions in the NPC-08 study and in the combined double-blind comparative studies
| System organ class/Event name | The NPC-08 study | Double-blind studies2,10,13) | |||||||
|---|---|---|---|---|---|---|---|---|---|
| All grades | All grades | Placebo | |||||||
| All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
| Total patients | 24 | 246 | 248 | ||||||
| Brain edema | 6 (25.0) | 2 (8.3) | – | 12 (4.9) | 2 (0.8) | 3 (1.2) | 12 (4.8) | 4 (1.6) | 2 (0.8) |
| Seizure | – | – | – | 31 (12.6) | 7 (2.8) | 2 (0.8) | 39 (15.7) | 11 (4.4) | 2 (0.8) |
| Major seizure | – | – | – | 1 (0.4) | – | – | 2 (0.8) | – | 1 (0.4) |
| Poor healing | – | – | – | 18 (7.3) | 4 (1.6) | – | 8 (3.2) | 1 (0.4) | – |
| Infection | – | – | – | 13 (5.3) | 2 (0.8) | 3 (1.2) | 16 (6.5) | 2 (0.8) | – |
| Headache | 2 (8.3) | – | – | 28 (11.4) | 8 (3.3) | – | 22 (8.9) | 8 (3.2) | 1 (0.4) |
| Hemiplegia | 1 (4.2) | – | – | 24 (9.8) | 5 (2.0) | – | 34 (13.7) | 15 (6.0) | – |
| Monoparesis | 1 (4.2) | – | – | – | – | – | – | – | – |
| Hemiparesis | 2 (8.3) | 2 (8.3) | – | – | – | – | – | – | – |
| Meningitis | – | – | – | 5 (2.0) | 2 (0.8) | – | 1 (0.4) | – | – |
| Hydrocephalus | – | – | – | 2 (0.8) | 1 (0.4) | 1 (0.4) | 1 (0.4) | – | – |
MedDRA/J Version 14.0. Event name: The same event name seen in the same patient was counted as one case. If severity differed between multiple episodes of the same event, then the most severe episode was selected. Incidence (%) = No. of patients who experienced adverse reaction/all patients studied × 100.