Table 2.
Reported adverse events (AEs) that were present in more than 10% (n = 4) of patients who received at least one dose of the vaccine (n = 31).
| Toxicity | Number of patients | (%) | |
|---|---|---|---|
| Hematologic disorders | Anemia | 10 | 32 |
| White blood cell count decrease | 4 | 13 | |
| Lymphocyte decrease | 15 | 48 | |
| Gastrointestinal disorders | Abdominal pain | 11 | 36 |
| Ascites | 6 | 19 | |
| Bloating | 5 | 16 | |
| Diarrhea | 7 | 23 | |
| Dyspepsia | 5 | 16 | |
| Nausea/vomiting | 8/10 | 26/32 | |
| AST/ALT elevation | 5 | 16 | |
| Bilirubin/ALP elevation | 5/6 | 16/19 | |
| General disorders and injection-site reactions | Fatigue | 18 | 58 |
| Pain | 10 | 32 | |
| Injection-site reaction | 29 | 94 | |
| Infections | Urinary tract infection | 7 | 23 |
| Respiratory tract infection | 7 | 23 | |
| Metabolism and nutritional disorders | Anorexia | 8 | 26 |
| Weight loss | 6 | 19 | |
| Dehydration | 5 | 16 | |
| Hypoalbuminemia | 7 | 23 | |
| Hypophosphatemia | 9 | 19 | |
| Musculoskeletal and connective tissue disorders | Back pain/flank pain | 9/4 | 29/13 |
| Chest wall pain | 4 | 13 | |
| Neoplasms | Tumor pain | 4 | 13 |
| Psychiatric disorders | Insomnia | 4 | 13 |
| Renal disorders | Creatinine elevation | 7 | 23 |
| Respiratory, thoracic, and mediastinal disorders | Cough | 10 | 32 |
| Dyspnea | 10 | 32 | |
| Pleural effusion | 4 | 13 | |
| Skin abnormality | Pruritus | 3 | 10 |
Twenty-three patients (74%) had grade ≥3 AEs. Six patients (19%) had grade ≥3 AEs attributable at least possibly to vaccine.