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 | |
|
|
AE = adverse event; = number of participants. |