TABLE 1.
Demographics and summary of all reported adverse events in bosutinib and placebo groups
| Demographics | |||
|---|---|---|---|
| Bosutinib (100 mg) | Placebo | P‐value | |
| Total enrolled | N = 13 | N = 13 | NA |
| Total finished end of treatment | 13 (100%) | 13 (100%) | 1 |
| Total dropped out | 0 (0%) | 0 (0%) | 1 |
| Average age (years) ±SD | 71.43 ± 7.94 | 74.45 ± 8.22 | 0.35 |
| Weight (kg) ±SD | 78.22 ± 7.63 | 82.61 ± 19.12 | 0.45 |
| Height (cm) ±SD | 174.28 ± 8.29 | 174.15 ± 4.34 | 0.96 |
| Body mass index (BMI) ± SD | 25.82 ± 2.75 | 27.06 ± 5.39 | 0.47 |
| Male | 12 (92.3%) | 13 (100%) | 1 |
| Female | 1 (7.7%) | 0 (0%) | |
| Race | 12 White (92.3%) | 12 White (92.3%) | 1 |
| 1 Black (7.7%) | 1 Asian (7.7%) | ||
| Montreal Cognitive Assessment (MoCA) at screening mean ± SD | 24.85 ± 3.5 | 23.92 ± 3.7 | 0.52 |
| Levodopa equivalent daily dose (LEDD) at baseline | 248.15 mg ± 296.33 | 417.35 mg ± 344.66 | 0.19 |
| LEDD at 12 weeks | 248.15 mg ± 296.33 | 417.35 mg ± 344.66 | 0.19 |
| Acetylcholinesterase inhibitors | No change | No change | |
| Adverse events (AEs) | |||
|---|---|---|---|
| System organ class | |||
| Preferred term | Number of events (%) | Number of events (%) | |
| Gastrointestinal disorders | |||
| Impaction | 0 (0%) | 1 (7.7%) | |
| General disorders | |||
| Falls | 3 (23.1%) | 3 (23.1%) | |
| Pain | 3 (23.1%) | 1 (7.7%) | |
| Flu | 0 (0%) | 1 (7.7%) | |
| Hepatic disorders | |||
| Liver transaminases | 1 (7.7%) | 0 (0%) | |
| Nervous system disorders | |||
| Post‐lumbar puncture headache | 1 (7.7%) | 0 (0%) | |
| Dizziness | 1 (7.7%) | 1 (7.7%) | |
| Renal and urinary disorders | |||
| Urinary incontinence | 1 (7.7%) | 0 (0%) | |
| Urinary tract infection | 1 (7.7%) | 0 (0%) | |
| Respiratory, thoracic, and mediastinal disorders | |||
| Upper respiratory infection | 0 (0%) | 1 (7.7%) | |
| Skin and subcutaneous disorder | |||
| Lesion | 0 0%) | 1 (7.7%) | |
Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase; SD, standard deviation