TABLE 5.
Adverse events related to the hemodialysis procedure (causality assessment)
| Diagnostic group | AEs causality assessment | |||||
|---|---|---|---|---|---|---|
| Probably associated | Possibly associated | Unable to determine | Unlikely associated | Not associated | Total | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n | |
| Drug hypersensitivity | 0 | 0 | 0 | 0 | 1 (100) | 1 |
| Pregnancy | 0 | 0 | 0 | 0 | 1 (100) | 1 |
| Malnutrition | 0 | 0 | 0 | 0 | 2 (100) | 2 |
| Pruritus | 0 | 0 | 0 | 0 | 5 (100) | 5 |
| Falls | 2 (20.0) | 0 | 0 | 0 | 8 (80.0) | 10 |
| Anemia | 0 | 0 | 0 | 0 | 12 (100) | 12 |
| Hypotension | 3 (20.0) | 4 (26.7) | 0 | 0 | 8 (53.3) | 15 |
| Fractures | 0 | 0 | 0 | 0 | 23 (100) | 23 |
| Clotted dialysis circuit | 30 (100) | 0 | 0 | 0 | 0 | 30 |
| Metabolic | 1 (3.3) | 0 | 4 (13.3) | 0 | 25 (83.4) | 30 |
| High blood pressure | 4 (12.1) | 1 (3.0) | 2 (6.1) | 0 | 26 (78.8) | 33 |
| Urinary tract infection | 0 | 0 | 0 | 0 | 37 (100) | 37 |
| Cerebrovascular disorders | 0 | 0 | 1 (2.4) | 1 (2.4) | 39 (95.2) | 41 |
| Respiratory disorders | 1 (2.0) | 0 | 0 | 0 | 49 (98.0) | 50 |
| Skin infections | 0 | 1 (1.8) | 0 | 0 | 54 (98.2) | 55 |
| Ischemic cardiovascular | 0 | 3 (5.0) | 0 | 0 | 57 (95.0) | 60 |
| Other infections | 0 | 0 | 1 (1.5) | 0 | 65 (98.5) | 66 |
| Infection of vascular access | 28 (42.4) | 7 (10.6) | 0 | 0 | 31 (47.0) | 66 |
| Cardiovascular nonischemic | 2 (2.7) | 7 (9.3) | 0 | 0 | 66 (88.0) | 75 |
| Gastrointestinal disorders | 0 | 0 | 1 (0.9) | 0 | 109 (99.1) | 110 |
| HD vascular access noninfectious | 27 (24.3) | 14 (12.6) | 1 (0.9) | 0 | 69 (62.2) | 111 |
| Other | 5 (2.7) | 6 (3.2) | 1 (0.5) | 0 | 174 (93.6) | 186 |
| Total n (%) | 103 (10.1) | 43 (4.2) | 11 (1.1) | 1 (0.1) | 861 (84.5) | 1019 |