Table 3.
Adverse events in the balANZ trial
| Event | Biocompatible | Control |
|---|---|---|
| (n=91) | (n=91) | |
| SAEs (n) | 162 | 209 |
| Patients with at least 1 SAE | 67 | 74 |
| Requiring permanent discontinuation of dialysis (i.e., withdrawn due to SAE) | 12 | 13 |
| Dialysate-related SAE | — | — |
| Death | 9 | 8 |
| cardiovascular death | 6 | 5 |
| infectious death | 1 | 1 |
| other | 2 | 2 |
| Infection | ||
| peritonitis | 27 | 45 |
| exit-site infection | 4 | 6 |
| tunnel infection | 1 | 2 |
| non-PD–related infection | 4 | 20 |
| Inadequate dialysis | 1 | 1 |
| Ultrafiltration failure | — | — |
| Hernia | 10 | 11 |
| Peritoneal leak | 1 | 3 |
| Gastrointestinal disorder | 9 | 4 |
| Constipation | 5 | 2 |
| Catheter blockage | 5 | 4 |
| Malposition | 1 | 2 |
| Hepatic disorder | 0 | 1 |
| Fluid overload | 1 | 3 |
| Newly diagnosed cancer | 4 | 3 |
| Hospitalization | ||
| cardiac | 12 | 18 |
| vascular | 13 | 9 |
| other | 24 | 23 |
The serious adverse events (SAEs) row indicates the total number of events, whereas all other rows denote the number of patients experiencing an event.