Table 5.
Events | Group I n = 53 | Group II n = 48 | Group III n = 48 |
---|---|---|---|
Subjects with any adverse event | 37 (69·8%) | 28 (58·3%) | 31 (64·5%) |
Severe | |||
Infection | 4 | 4 | 2 |
Other | Renal failure Cellulitis | Renal failure (lethal) Myocardial infarct Pneumonia | Acute pulmonary oedema (2; 1 lethal) Cellulitis Knee abscess |
Mild or moderate (occurring in 10 patients or more) | |||
Pain at the administration site | 13 (24·5%) | 13 (27·1%) | 20 (41·7%) |
Burning sensation | 12 (22·6%) | 10 (20·8%) | 14 (29·2%) |
Shivering | 17 (32·1%) | 8 (16·7%) | 2 (4·2%) |
Local infection | 3 (5·7%) | 4 (8·3%) | 7 (18·8%) |
Chills | 11 (20·8%) | 4 (8·3%) | 1 (2·1%) |
Anaemia | 4 (7·5%) | 3 (6·3%) | 5 (10·4%) |
Fever | 2 (3·8%) | 4 (8·3%) | 6 (12·5%) |
Nauseas | 4 (7·5%) | 1 (2·1%) | 2 (4·2%) |
Vomits | 3 (5·7%) | 2 (4·2%) | 1 (2·1%) |