Table 3.
Adverse events recorded during treatment
| Adverse Events | Placebo N = 21 | AP N = 23 |
|---|---|---|
| Serious | ||
| Infection | ||
| Herpes simplex virus-1 encephalitis | 0 | 1 |
| Urinary/pulmonary sepsis, death | 1 | 0 |
| Pneumonia | 1 | 0 |
| Influenza | 1 | 0 |
| Pyelonephritis | 0 | 1 |
| PML | 0 | 0 |
| Cardiovascular | ||
| Acute coronary syndrome | 2 | 1 |
| Syncope | 2 | 0 |
| Pacemaker installation | 2 | 0 |
| Cancer | 0 | 0 |
| Mild – Moderate | ||
| Infections | ||
| Upper respiratory tract infection | 5 | 8 |
| Lower urinary tract infection | 1 | 3 |
| Gastrointestinal infection | 2 | 2 |
| Other | ||
| Pruriginous rash | 0 | 12 |
| Dysgeusia | 0 | 3 |
| Falls | 2 | 4 |
| Mood/sleep disturbances | 1 | 3 |
| Gastroesophageal reflux | 1 | 1 |
| Lumbar pain | 1 | 1 |
| Joint pain | 2 | 1 |
| Bursitis | 0 | 1 |
| Cataract surgery | 0 | 1 |
| Gastric ulcer | 1 | 0 |
| Vertigo | 1 | 0 |
| Constipation | 1 | 0 |
Comorbidities were balanced between groups (data not shown)