| Adverse events classified as Serious | Intensity | N | % |
| Serious, life-threatening, or incapacitating | 3 | 20.0 | |
| Death | 3 | 20.0 | |
| Severe | 7 | 46.7 | |
| Moderate | 2 | 13.3 | |
| Total | 15 | 100 |