Table 4.
Clinical adverse events (safety analysis)a
| 2% taurolidine (n = 53) | 0.9% saline (n = 52) | P value | |
|---|---|---|---|
| No. of patients – (%) | |||
| Adverse events | |||
| Patients with ≥1 adverse events (≥5% of patients) | 32 (60) | 39 (75) | 0.14 |
| Abdominal pain | 4 (8) | 4 (8) | >0.99 |
| Catheter dislocation | 2 (4) | 3 (6) | 0.68 |
| Catheter exit site infection | 5 (9) | 4 (8) | >0.99 |
| CVAD occlusion | 2 (4) | 5 (10) | 0.27 |
| CRBSI | 5 (9) | 18 (35) | 0.002 |
| Pneumonia | 4 (8) | 1 (2) | 0.36 |
| Pyrexia | 1 (2) | 4 (8) | 0.21 |
| Urinary tract infection | 5 (9) | 5 (10) | >0.99 |
| Patients with drug‐related adverse events (Intensity) | 2 (4) | 2 (4) | >0.99 |
| Dysgeusia (moderate) | 1 | 0 | |
| Dizziness (moderate) | 1 | 0 | |
| Erythema to catheter exit site (moderate) | 1 | 0 | |
| Flushing (mild) | 0 | 1 | |
| Reduced catheter patency (mild) | 0 | 1 | |
| Serious adverse events | |||
| Patients with ≥1 serious adverse event (≥2% of patients) | 23 (43) | 34 (65) | 0.03 |
| Abdominal pain | 1 (2) | 2 (4) | 0.62 |
| Catheter dislocation | 2 (4) | 3 (6) | 0.68 |
| Catheter exit site infection | 4 (8) | 3 (6) | >0.99 |
| CVAD occlusion | 0 (0) | 3 (6) | 0.12 |
| CRBSI | 4 (8) | 18 (35) | 0.001 |
| Pneumonia | 4 (8) | 0 (0) | 0.12 |
| Patients with serious drug‐related adverse event | 0 (0) | 0 (0) | >0.99 |
| Discontinuation of treatment due to adverse event | 11 (21) | 23 (44) | 0.02 |
| Death | 2 (4) | 0 (0) | 0.50 |
| Euthanasia after bowel obstruction | 1 | 0 | |
| Ruptured abdominal aneurysm | 1 | 0 | |
CRBSI, catheter‐related bloodstream infection; CVAD, central venous access device.
a
P values were calculated with the use of Fisher's exact test.