Table 6 Frequency of adverse events during the study
Adverse event | Formulation A N = 16 | Formulation B N = 16 | Both formulations N = 16 | p (McNemar's test) |
|---|---|---|---|---|
Any adverse event | 16 (100%) | 16 (100%) | 16 (100%) | --- |
Leukopenia* | 14 (87.5%) | 15 (93.8%) | 14 (87.5%) | 1.00 |
Fever | 13 (81.3%) | 11 (68.8%) | 9 (56.3%) | 0.69 |
Thrombocytopenia** | 9 (56.3%) | 12 (75%) | 9 (56.3%) | 0.25 |
Increase of transaminases! | 10 (62.5%) | 11 (68.8%) | 8 (50%) | 1.00 |
Asthenia | 8 (50%) | 6 (37.5%) | 4 (25%) | 0.69 |
Headache | 6 (37.5%) | 7 (43.8%) | 2 (12.5%) | 1.00 |
Increase of creatinine!! | 7 (43.8%) | 5 (31.3%) | 0 | 0.77 |
Ardor at injection site | 0 | 12 (75%) | 0 | 0.0005 |
Erythema at injection site | 5 (31.3%) | 3 (18.8%) | 2 (12.5%) | 0.625 |
Hypertension | 4 (25%) | 2 (12.5%) | 1 (6.3%) | 0.625 |
Chills | 1 (6.3%) | 4 (25%) | 0 | 0.375 |
Myalgias | 2 (12.5%) | 3 (18.8%) | 1 (6.3%) | 1.00 |
Lumbar pain | 2 (12.5%) | 2 (12.5%) | 1 (6.3%) | 1.00 |
Pruritus | 3 (18.8%) | 1 (6.3%) | 1 (6.3%) | 0.50 |
Tachycardia | 2 (12.5%) | 1 (6.3%) | 1 (6.3%) | 1.00 |
Somnolence | 1 (6.3%) | 1 (6.3%) | 0 | 1.00 |
Warmth at injection site | 2 (12.5%) | 0 | 0 | 0.50 |
Hyperesthesia | 2 (12.5%) | 0 | 0 | 0.50 |
Anorexia | 1 (6.3%) | 0 | 0 | 1.00 |
Vomiting | 0 | 1 (6.3%) | 0 | 1.00 |
Arthralgias | 0 | 1 (6.3%) | 0 | 1.00 |