Table 2. Adverse events (AEs) (possibly, probably, or definitely related).
| Total | 150 µg (n=10) |
300 µg (n=12) |
600 µg (n=10) |
|||||
|---|---|---|---|---|---|---|---|---|
| No. | %* | No. | %* | No. | %* | No. | %* | |
| Most common related adverse events | ||||||||
| Injection site reaction | 26 | 81 | 8 | 80 | 10 | 83 | 8 | 80 |
| Influenza-like symptoms | 14 | 44 | 5 | 50 | 7 | 58 | 2 | 20 |
| Fatigue | 8 | 25 | 4 | 40 | 3 | 25 | 1 | 10 |
| Nausea | 6 | 19 | 4 | 40 | 1 | 8 | 1 | 10 |
| Chills | 6 | 19 | 3 | 30 | 3 | 25 | 0 | 0 |
| Myalgia | 6 | 19 | 3 | 30 | 3 | 25 | 0 | 0 |
| Headache | 5 | 16 | 1 | 10 | 3 | 25 | 1 | 10 |
| Bone pain | 5 | 16 | 0 | 0 | 3 | 25 | 2 | 20 |
| All related abnormal autoimmune serologies | ||||||||
| ANA | 1 | 3 | 1 | 10 | 0 | 0 | 0 | 0 |
| Anti-DS DNA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| C3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| TSH | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| GAD65 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Glucose | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adverse events during long-term follow-up† | ||||||||
| Psoriatic arthritis | 1 | 3 | 0 | 0 | 0 | 0 | 1 | 10 |
| Subclinical hypothyroidism | 2 | 6 | 1 | 10 | 1 | 8 | 0 | 0 |
| All related AE gradings (n=149)‡ | ||||||||
| 1 | 144 | 97 | 55 | 37 | 58 | 39 | 31 | 21 |
| 2 | 5 | 3 | 2 | 1 | 0 | 0 | 3 | 2 |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
*
Percentage of patients with related AEs.
†
Observed more than 6 months after trial completion.
‡
Of all related AE (n=149), long term toxicity not included. Source of terms CTCAE V.4.0.
CTCAE, Common Terminology Criteria for Adverse Events; TSH, thryoid stimulating hormone.