Table 4.
Severity of adverse events.
| Severity (SAVES-V2 grade) | Number (% of all patients) |
||
|---|---|---|---|
| Overall | Cranial | Spinal | |
| I - No treatment, no adverse effect | 30 (0.7) | 11 (0.5) | 19 (1.0) |
| II - Treatment minor invasive/simple, no long-term effect | 504 (12.1) | 218 (9.7) | 286 (14.9) |
| III - Treatment invasive/complex, adverse effect most likely temporary (<6 months) | 309 (7.4) | 172 (7.6) | 137 (7.1) |
| IV - Treatment invasive/complex, adverse effect most likely prolonged (>6 months) | 87 (2.1) | 62 (2.7) | 25 (1.3) |
| V - Significant neural injury or serious life-threatening event | 54 (1.3) | 38 (1.7) | 16 (0.8) |
| VI - AE resulting in death | 59 (1.4) | 39 (1.7) | 20 (1.0) |
Incidence of cases with adverse events, graded by severity according to the Spinal Adverse Events Severity System, version 2 (SAVES-V2). The most severe adverse event defined the grade in cases with multiple adverse events.