Event, n (%) | NPI (n=74) | NIV (n=76) | p-value |
---|---|---|---|
Anaemia | 9 (12.2) | 8 (10.5) | 0.752 |
Aspartate aminotransferase increased | 5 (6.8) | 0 (0.0) | 0.021a |
Colonic perforation | 0 (0.0) | 1 (1.3) | 1.000 |
Creatinine increased | 2 (2.7) | 2 (2.6) | 0.978 |
Dehydration | 3 (4.1) | 1 (1.3) | 0.298 |
Dyspnoea | 6 (8.1) | 0 (0.0) | 0.011a |
Hyponatraemia | 9 (12.2) | 1 (1.3) | 0.008a |
Hypotension | 8 (10.8) | 0 (0.0) | 0.003a |
Vaginal fistula | 3 (4.1) | 0 (0.0) | 0.076 |
Lipases increased | 4 (5.4) | 4 (5.3) | 0.969 |
Lung infection | 3 (4.1) | 3 (3.9) | 0.973 |
Nausea | 4 (5.4) | 2 (2.6) | 0.386 |
Nervous system disorders | 8 (10.8) | 1 (1.3) | 0.014a |
Skin infection | 3 (4.1) | 0 (0.0) | 0.076 |
Urinary tract infection | 4 (5.4) | 0 (0.0) | 0.040a |
≥ 2 AEs in one patient | 23 (31.1) | 12 (15.8) | 0.027a |