Table 2.
Summary of adverse events. AE = adverse event; SAE = serious adverse event.
| Number of Patients (%) | N = 26 | Percent |
|---|---|---|
| Any AEs | 23 | 88.5% |
| Any drug-related AE | 22 | 84.6% |
| Any AEs leading to permanent discontinuation of the study drug or withdrawal | 0 | 0 |
| Any AE of severe intensity | 3 | 11.5% |
| Any drug-related AE of severe intensity | 2 | 6.1% |
| Any drug-related AEs leading to permanent discontinuation of the study drug or withdrawal | 0 | 0 |
| Any serious AEs (SAEs) | 0 | 0 |
| Any drug-related SAEs | 0 | 0 |
| Any fatal SAEs | 0 | 0 |
| Any drug-related fatal SAEs | 0 | 0 |
| AEs reported by ≥5% of participants | ||
| Pain (in the site of injection) | 17 | 65.4% |
| Fever | 7 | 26.9% |
| Headache | 7 | 26.9% |
| Nausea | 4 | 15.4% |
| Fatigue | 3 | 11.5% |
| Malaise | 2 | 7.7% |
| Increased volume site of injection | 2 | 7.7% |
| Stomach pain | 2 | 7.7% |
| Chills | 2 | 7.7% |