|
Event
|
Severity
|
Intervention relationshipa
|
Expected
|
# Participants
|
|---|
|
Blood analyses
|
|
Leukocytopenia
|
Mild
|
2-3
|
Yes
|
1
|
|
Hypokalemia
|
Mild
|
1-2
|
Yes
|
7
|
|
Hyponatremia
|
Mild
|
2
|
Yes
|
1
|
|
Hypovolemia
|
Mild
|
1
|
Yes
|
1
|
|
Gastrointestinal symptoms
|
|
Nausea/vomiting
|
Mild
|
3
|
Yes
|
1
|
|
Obstipation
|
Mild
|
2
|
Yes
|
2
|
|
Decreased appetite
|
Mild
|
2
|
No
|
1
|
|
Weight loss
|
Mild
|
2
|
Yes
|
1
|
|
Genitourinary
|
|
Diuresis
|
Mild
|
1
|
Yes
|
1
|
|
Infections
|
|
Viral infection
|
Mild
|
3
|
No
|
1
|
|
Urinary tract infection
|
Mild
|
2
|
No
|
1
|
|
Behavioral symptoms
|
|
Aggression
|
Moderate
|
2
|
No
|
2
|
|
Irritability
|
Mild
|
2
|
No
|
2
|
|
Anxiety
|
Mild
|
2
|
No
|
1
|
|
Musculoskeletal
| | | |
1
|
|
Medial malleolus fracture
|
Moderate
|
3
|
No
|
1
|
|
Humerus fracture
|
Moderate
|
3
|
No
|
1
|
|
Other
|
|
Hypotension
|
Mild
|
1
|
Yes
|
1
|
|
Hypothermia
|
Mild
|
3
|
No
|
1
|
|
Dehydration
|
Mild
|
1
|
Yes
|
1
|
|
Palpitations
|
Mild
|
2
|
No
|
1
|
- Note: a1: Definitely related; 2: Possibly related; 3: Not related
