Table 1.
Adverse events (AEs) reported throughout the study period
| Group A(Premedication) (n =10) | Group B(increasing dose) (n =12) | |||
|---|---|---|---|---|
| AEs, n (%) | Any grade | Grade≥2 | Any grade | Grade≥2 |
| Constitutional symptoms | ||||
| Pyrexia | 5 (50) | 1 (10) | 3 (25) | 2 (17) |
| Myalgia | 4 (40) | 0 | 7 (58) | 0 |
| Chills | 2 (20) | 0 | 4 (33) | 0 |
| Dizziness | 2 (20) | 0 | 1 (8) | 0 |
| Headache | 2 (20) | 0 | 4 (33) | 1 (8) |
| Flushing | 2 (20) | 0 | 1 (8) | 0 |
| Fatigue | 1 (10) | 0 | 1 (8) | 0 |
| Other AEs | ||||
| Activated partial thromboplastin time prolonged | 9 (90) | 6 (60) | 11 (92) | 1 (8) |
| Alanine aminotransferase increased | 2 (20) | 0 | 3 (25) | 1 (8) |
| Nausea | 3 (30) | 0 | 0 | 0 |
| Folliculitis | 3 (30) | 0 | 0 | 0 |
| Blurred vision | 0 | 0 | 2 (17) | 0 |
| Eye pain | 0 | 0 | 1 (8) | 0 |
| Vomiting | 1 (10) | 0 | 0 | 0 |
| Injection site extravasation | 1 (10) | 0 | 0 | 0 |
| Injection site reaction | 1 (10) | 0 | 1 (8) | 0 |
| Contusion | 1 (10) | 0 | 0 | 0 |
| Excoriation | 1 (10) | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 1 (10) | 0 | 1 (8) | 0 |
| Blood creatine phosphokinase increased | 1 (10) | 1 (10) | 0 | 0 |
| Gamma-glutamyl transferase increased | 1 (10) | 0 | 1 (8) | 0 |
| Lymphocyte count decreased | 1 (10) | 1 (10) | 0 | 0 |
| Decreased appetite | 1 (10) | 0 | 0 | 0 |
| Muscle spasms | 0 | 0 | 1 (8) | 0 |
| Paresthesia | 1 (10) | 0 | 0 | 0 |
| Presyncope | 1 (10) | 1 (10) | 0 | 0 |
| Haematuria | 1 (10) | 0 | 0 | 0 |
| Dermatitis contact | 1 (10) | 0 | 0 | 0 |
| Hyperhidrosis | 1 (10) | 0 | 0 | 0 |
| Hot flush | 1 (10) | 0 | 0 | 0 |