Table 5.
Adverse events
| Baseline | Placebo | MLE4901 | ||
|---|---|---|---|---|
| Respiratory, thoracic, and mediastinal disorders | ||||
| Upper respiratory infection (grade 1) | 0 | 3 | 6 | |
| Nervous system disorders | ||||
| Headache (grade 1) | 0 | 2 | 3 | |
| Nervous system disorder, other, migraine (grade 2) | 0 | 2 | 3 | |
| Nervous system disorder, other, S1 shingles (grade 1) | 0 | 1 | 0 | |
| Sinus pain (grade 1) | 0 | 0 | 1 | |
| Dysesthesia (grade 1) | ||||
| Lip and nose | 0 | 0 | 1 | |
| Jaw and mouth | 0 | 0 | 1 | |
| Gastrointestinal disorders | ||||
| Dry mouth (grade 1) | 0 | 0 | 2 | |
| Nausea (grade 1) | 0 | 1 | 2 | |
| Vomiting (grade 1) | 0 | 0 | 1 | |
| Diarrhoea (grade 1) | 0 | 0 | 2 | |
| Constipation (grade 1) | 0 | 1 | 0 | |
| Gastro-esophageal reflux disease (grade 1) | 0 | 0 | 1 | |
| Investigations | ||||
| ALT increased (grade 1) with normal AST | 1 | 1 | 0 | |
| AST increased (grade 1) with normal ALT | 1 | 0 | 1 | |
| ALT increased (grade 1) with AST increased (grade 1) | 0 | 1 | 3 | |
| ALT increased (grade 2) with AST increased (grade 1) | 1 | 0 | 1 | |
| ALT increased (grade 3) with AST increased (grade 1) | 0 | 0 | 2 | |
| Blood bilirubin increased (grade 1) | 3 | 0 | 0 | |
| Alkaline phosphatase increased (grade 1) | 1 | 0 | 1 | |
| Creatinine increased (grade 1) | 1 | 1 | 0 | |
| Musculoskeletal and connective tissue disorders | ||||
| Chest wall pain (grade 1) | 0 | 1 | 0 | |
| Bruising, great toe after trauma (grade 1) | 0 | 1 | 0 | |
| Neck pain, after road traffic collision (grade 2) | 0 | 1 | 0 | |
| Buttock pain, traumatic (grade 1) | 0 | 0 | 1 | |
| Localised oedema, fingers (grade 1) | 0 | 0 | 1 | |
| Myalgia | ||||
| Traumatic (grade 1) | 0 | 0 | 1 | |
| Atraumatic (grade 1) | 0 | 1 | 1 | |
| Skin and subcutaneous tissue disorders | ||||
| Hypertrichosis, chin (grade 1) | 0 | 0 | 1 | |
| Skin and subcutaneous tissue disorders, other, weak nails (grade 1) | 0 | 0 | 1 | |
| Pruritus | ||||
| Breast (grade 1) | 0 | 0 | 1 | |
| Hands and feet, known eczema (grade 1) | 0 | 0 | 1 | |
| Ear and labyrinth disorders | ||||
| Ear and labyrinth disorders, other, blocked ears (grade 1) | 0 | 0 | 1 | |
Number of events recorded during the study period in all participants who received at least one dose of study medication (placebo or MLE4901; n=37). All participants were asked about adverse events at each weekly visit by the study doctor. Any reported symptom was recorded and then coded according to the Common Terminology Criteria for Adverse Events version 4.0. Counting rules were used to determine group assignment for events within the crossover trial. Group assignment: baseline, from screening through to just before the first dose of the study medication (placebo or MLE4901); placebo, from first dose of placebo to either just before the first dose of MLE4901 (if placebo received first) or through to the end of follow-up (if placebo received second); MLE4901, from first dose of MLE4901 to either just before the first dose of placebo (if MLE4901 received first) or through to the end of follow-up (if MLE4901 received second). ALT=alanine aminotransferase. AST=aspartate aminotransferase.