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 |