Table 2.
Safety– number of patients (frequency) presenting non-serious adverse events during treatment cycles.
| Adverse events | Treatment group |
Total (N = 36) | ||
|---|---|---|---|---|
| 2 MIU (N = 12) | 1 MIU (N = 12) | Placebo (N = 12) | ||
| Injection site reactions | 12 (100%) | 11 (91·7%) | 1 (8·3%) | 24 (66·7%) |
| Flu-like symptoms | 3 (25·0%) | 0 | 0 | 3 (8·3%) |
| Fatigue | 2 (16·7%) | 1 (8·3%) | 2 (16·7%)0 | 5 (13·9%) |
| Gastro-intestinal signs | 2 (16·7%) | 1 (8·3%) | 0 | 3 (8·3%) |
| Rhinitis | 2 (16·7%) | 0 | 0 | 2 (5·6%) |
| Nasopharyngitis | 1 (8·3%) | 1 (8·3%) | 0 | 2 (5·6%) |
| Headache/Migraine | 4 (33·3%) | 0 | 0 | 4 (11·1%) |
| Chest pain | 1 (8·3%) | 0 | 0 | 1 (2·8%) |
| Cold sweat | 0 | 1 (8·3%) | 0 | 1 (2·8%) |
| Arthralgia | 1 (8·3%)0 | 0 | 0 | 1 (2·8%) |
| Myalgia | 0 | 0 | 1 (8·3%) | 1 (2·8%) |
| Total | 12 (100%) | 11 (91·7%) | 3 (25·0%) | 26 (72·2%) |