Table 2.
Adverse events among subjects with a catheter placed
| Number of subjects with event (column %) | ||||
|---|---|---|---|---|
| Event | Subset | Test System (n = 49) | Control System (n = 46) | Total (n = 95) |
| Dysuria | Total | 1 (2.0) | 0 (0) | 1 (1.0) |
| Possibly relateda | 0 (0.0) | 0 (0) | 0 | |
| Oliguria | Total | 2 (4.0) | 0 (0.0) | 2 (2.1 |
| Possibly relateda | 0 (0.0) | 0 (0.0) | 0 | |
| Urinary retention | Total | 4 (8.2) | 2 (4.3) | 6 (6) |
| Possibly relateda | 2 (4.0) | 2 (4.3) | 4 (4.2) | |
| Decreased urine output | Total | 1 (2.0) | 1 (2.2) | 2 (2.1) |
| Possibly relateda | 1 (2.0) | 1 (2.2) | 2 (2.1) | |
| Total | Total | 8 (16.3) | 3 (6.5) | 11 (11.6) |
| Possibly relateda | 3 (6.1) | 3 (6.5) | 6 (6.3) | |
Whether adverse events were possibly related to the study catheter was determined by members of the study team based on the clinical context, without regard for study group.