Research Article
Efficacy of the Enteroadsorbent Silicol®gel in Adults with Irritable Bowel Syndrome Subtypes IBS-D or Mixed: Observational Open-Label Study
| | AEs by system organ class | = | Causality assessment | | Not related to treatment (=) | Related to treatment (=) |
| | Gastrointestinal disorders | | Diarrhoea | 4 | 2 | 2 | | Dyspepsia | 5 | 3 | 2 | | Gastroenteritis | 1 | 1 | | | Constipation | 3 | | 3 | | Abdominal pain | 2 | 1 | 1 | | Anorexia | 1 | | 1 | | Stool urgency | 2 | | 2 | | Vomiting | 1 | 1 | | | Infections and infestations | | Upper respiratory tract infection | 7 | 7 | | | Flu-like illness | 1 | 1 | | | COVID-19 | 2 | 2 | | | Lower respiratory tract infection | 2 | 2 | | | Urinary tract infection | 2 | 2 | | | Psychiatric disorders | | Emotional stress | 1 | 1 | | | Reproductive system and breast disorders | | Menorrhagia | 1 | 1 | | | Dysmenorrhoea | 1 | 1 | | | Nervous system disorders | | Headache | 4 | 4 | | | Blood and lymphatic system disorders | | Anaemia | 1 | 1 | | | General disorders and administration site conditions | | Malaise | 2 | 2 | | | Musculoskeletal and connective tissue disorders | | Shoulder tendonitis | 1 | 1 | | | Ear and labyrinth disorders | | Bilateral ear infection | 1 | 1 | | | Serious AEs | | Optic neuritis | 1 | 1 | | | Vomiting | 1 | 1 | |
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AE = adverse event; = number of participants. |
