Side effects and complications occurring in weeks 2–4 after gastrointestinal bleeding
| Side effects and complications (evolution) | SMS + Is-5-Mn | SMS + placebo | Statistical analysis |
| Hepatic encephalopathy | 0 | 4/30 (13) | NS |
| Ascites | 4/30 (13) | 2/30 (7) | NS |
| Pneumonia | 1/30 (3) | 1/30 (3) | NS |
| Functional renal failure | 1/30 (3) | 4/30 (13) | NS |
| Unrinary tract infection | 0 | 1/30 (3) | NS |
| Urinary acute retention | 0 | 1/30 (3) | NS |
| Skin ulcer | 0 | 1/30 (3) | NS |
| Mallory Weiss | 0 | 1/30 (3) | NS |
| Bacteraemia | 0 | 1/30 (3) | NS |
| Hypotension related to β blockers | 0 | 1/30 (3) | NS |
| Bronchospasm related to β blockers | 0 | 1/30 (3) | NS |
| Heart failure related to β blockers | 1/30 (3) | 0 | NS |
| Stroke | 1/30 (3) | 0 | NS |
| Rectal bleeding | 1/30 (3) | 1/30 (3) | NS |
Values are number (%).
SMS, somatostatin; Is-5-Mn, isosorbide 5-mononitrate.