Table 2.
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%) |