Table 2.
Adverse Treatment Reactions
| System Organ Class | Adverse Treatment Reactiona | UDCA (n=20) | Placebo (n=11) |
|---|---|---|---|
| Gastrointestinal disorders | Abdominal distension | 1 (5.0%) | 1 (9.1%) |
| Abdominal pain | 1 (5.0%) | 1 (9.1%) | |
| Constipation | 1 (5.0%) | 1 (9.1%) | |
| Diarrhoea | 5 (25.0%) | 1 (9.1%) | |
| Dry mouth | 0 (0.0%) | 1 (9.1%) | |
| Gastroesophageal reflux disease | 0 (0.0%) | 1 (9.1%) | |
| Nausea | 2 (10.0%) | 0 (0.0%) | |
| Salivary hypersecretion | 1 (5.0%) | 0 (0.0%) | |
| Metabolism and nutrition disorders | Abnormal loss of weight | 1 (5.0%) | 0 (0.0%) |
| Musculoskeletal disorders | Arthralgia | 1 (5.0%) | 0 (0.0%) |
| Nervous system disorders | Parkinson’s Disease progression | 0 (0.0%) | 1 (9.1%) |
| Restless legs syndrome | 1 (5.0%) | 0 (0.0%) | |
| Skin and subcutaneous tissue disorders | Pruritus | 1 (5.0%) | 0 (0.0%) |
| Rash | 1 (5.0%) | 0 (0.0%) |
a
All participants with at least 28 days exposure to study treatment are listed. Only adverse reactions recorded as having a definite, probable or possible relationship to trial medication which started on or after first dose are included. Participants are counted once per row but may appear in more than one row. Adverse treatment reactions observed in more than one trial participant are highlighted in italics and bold.