Clinical Study
A Prospective, Multinational Pharmacoepidemiological Study of Clinical Conversion to Sirolimus Immunosuppression after Renal Transplantation
Table 4
Principal adverse events by category and by time after transplant.
| | Time of conversion after transplant | Total | <1 year | >1 year |
| | Number of subjects | 458 | 187 | 297 | | Any event* | 458 (95%) | 182 (97%) | 276 (93%) | | Vascular system | 241 (50%) | 103 (55%) | 138 (47%) | | Hypertension | 226 (47%) | 95 (51%) | 131 (44%) | | Cardiac system* | 46 (10%) | 25 (13%) | 21 (7%) | | Coronary artery disease | 8 (2%) | 4 (2%) | 4 (1%) | | Myocardial infarction | 6 (1%) | 1 (0.5%) | 5 (2%) | | Metabolism and nutrition | 249 (51%) | 102 (55%) | 147 (50%) | | Hyperlipidemia* | 128 (26%) | 66 (35%) | 62 (21%) | | Diabetes | 67 (14%) | 21 (11%) | 46 (16%) | | Hypercholesterolemia | 31 (6%) | 7 (4%) | 24 (8%) | | Blood and lymphatic system | 146 (30%) | 60 (32%) | 86 (29%) | | Anaemia | 116 (24%) | 44 (24%) | 72 (24%) | | Leukopenia | 29 (6%) | 13 (7%) | 16 (5%) | | Thrombocytopenia | 7 (1%) | 3 (2%) | 4 (1%) | | Gastrointestinal system | 127 (26%) | 41 (22%) | 86 (29%) | | Mouth ulceration | 2 (0.5%) | 0 (0%) | 2 (1%) | | Diarrhoea | 67 (14%) | 21 (11%) | 46 (16%) | | Infections | 288 (60%) | 120 (64%) | 168 (57%) | | Cytomegalovirus infection* | 57 (12%) | 35 (19%) | 22 (7%) | | Urinary tract infection | 120 (25%) | 54 (29%) | 66 (22%) | | Musculoskeletal system | 73 (15%) | 25 (13%) | 48 (16%) | | Bone pain | 3 (0.5%) | 1 (0.5%) | 2 (0.5%) | | Renal and urinary system | 108 (22%) | 33 (18%) | 75 (25%) | | Proteinuria* | 49 (10%) | 10 (5%) | 39 (13%) | | Lymphocele | 9 (2%) | 6 (3%) | 3 (1%) | | Edema | 28 (6%) | 16 (9%) | 12 (4%) | | Peripheral edema | 40 (8%) | 14 (7%) | 26 (9%) | | Respiratory system | 45 (9%) | 17 (9%) | 28 (9%) | | Pneumonitis | 3 (0.5%) | 0 (0%) | 3 (1%) | | Neoplasms (malignant) | 43 (9%) | 12 (6%) | 31 (10%) | | Skin rash | 1 (0.2%) | 1 (0.5%) | 0 (0%) |
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