|
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)
