Table 3.
Secondary outcomes and adverse events
| Methylnaltrexone (N = 39) |
Placebo (N = 43) |
p value | |
|---|---|---|---|
| Number of patients requiring rescue laxatives (at least once) [N (%)] | 17 (43.6) | 17 (39.5) | 0.74a |
| Number of bowel movements per day [median (IQR)] | |||
| Days 1–3 | 0.67 (0, 1) | 0.67 (0, 1.67) | 0.58b |
| Days 4–28 | 1.38 (1, 2) | 2 (1.54, 2.5) | 0.01b |
| Diarrhoea reported as adverse event [N (%)] | 8 (20.0) | 11 (25.6) | 0.61c |
| Number (proportion) of patients with diarrhoea at least once | 23 (59%) | 36 (83.7%) | 0.02a |
| Number (proportion) of bowel movements with diarrhoea | 208 (23.3%) | 336 (23.6%) | 0.69a |
| Number of bowel movements with diarrhoea per day [median, IQR] | |||
| Days 1–3 | 0.2 (0; 0–0.3) | 0.4 (0; 0–0.3) | 0.27b |
| Days 4–28 | 0.3 (0; 0–0.4) | 0.4 (0.4; 0.1–0.6) | 0.03b |
| Number of patients (%) with clostridium difficile infection (PCR or toxin-positive) | 3 (7.7) | 7 (16.3) | 0.32c |
| Number of patients (%) with positive microbiology blood cultures | 19 (48.7) | 27 (62.8) | 0.27c |
| Number of patients (%) experiencing adverse eventsd | 9 (23.1) | 13 (31.7) | 0.62c |
| Number of patients (%) experiencing serious adverse eventsd | 2 (5.1) | 2 (4.7) | 0.65c |
aPearson’s Chi-squared test
bWilcoxon test (two-sided)
cFisher’s exact test
dAll were expected and not related to the study treatment