Table 2.
Summary of treatment-emergent adverse events during the trial.
| Outcome | Placebo (n = 15 events) | Ursodeoxycholic acid (n = 22 events) | Total (n = 37 events) |
|---|---|---|---|
| Overall safety | |||
| Total adverse events | 15 | 22 | 37 |
| Nonserious adverse events | 15 (100.0%) | 18 (81.8%) | 33 (89.2%) |
| Serious adverse events | 0 (0.0%) | 4 (18.2%) | 4 (10.8%) |
| Adverse events leading to treatment discontinuation | 0 | 0 | 0 |
| Organ system | |||
| Respiratory | 3 (20.0%) | 4 (18.2%) | 7 (18.9%) |
| Gastrointestinal | 1 (6.7%) | 5 (22.7%) | 6 (16.2%) |
| Genitourinary/renal | 0 (0.0%) | 5 (22.7%) | 5 (13.5%) |
| Musculoskeletal/connective tissue | 6 (40.0%) | 4 (18.2%) | 10 (27.0%) |
| Eye/ear/nose/throat | 1 (6.7%) | 0 (0.0%) | 1 (2.7%) |
| Psychological | 0 (0.0%) | 1 (4.5%) | 1 (2.7%) |
| Skin/subcutaneous tissue | 0 (0.0%) | 1 (4.5%) | 1 (2.7%) |
| Endocrine | 0 (0.0%) | 1 (4.5%) | 1 (2.7%) |
| Other | 4 (26.7%) | 1 (4.5%) | 5 (13.5%) |
| Severity | |||
| Mild | 3 (20.0%) | 5 (22.7%) | 8 (21.6%) |
| Moderate | 9 (60.0%) | 13 (59.1%) | 22 (59.5%) |
| Severe | 2 (13.3%) | 3 (13.6%) | 5 (13.5%) |
| Not recorded/unknown | 1 (6.7%) | 1 (4.5%) | 2 (5.4%) |
| Relationship to study drug | |||
| Definite | 5 (33.3%) | 5 (22.7%) | 10 (27.0%) |
| Probable | 2 (13.3%) | 0 (0.0%) | 2 (5.4%) |
| Remote | 0 (0.0%) | 3 (13.6%) | 3 (8.1%) |
| None/not related | 8 (53.3%) | 11 (50.0%) | 19 (51.4%) |
| Not recorded/unknown | 0 (0.0%) | 3 (13.6%) | 3 (8.1%) |
| Outcome | |||
| Recovered | 12 (80.0%) | 19 (86.4%) | 31 (83.8%) |
| Recovered with sequelae | 0 (0.0%) | 2 (9.1%) | 2 (5.4%) |
| Continuing at end of study | 3 (20.0%) | 1 (4.5%) | 4 (10.8%) |
For severity, intensity was recorded for 35 of 37 events, with two events (one during placebo and one during ursodeoxycholic acid treatment) having no recorded intensity. For the relationship with study treatment, 19 events were recorded as having no relationship (“none”), whilst three events during UDCA treatment had no relationship assessment recorded.