|
Adverse events
|
Dronabinol (n=24)
|
Placebo (n=24)
|
Central nervous system
|
19 (79), 61
|
8 (33), 20
|
Dizziness or lightheadedness
|
14 (58)*, 26
|
4 (17), 5
|
Tiredness or drowsiness
|
10 (42), 12
|
6 (25), 10
|
Fatigue
|
1 (4), 2
|
0 (0), 0
|
Balance difficulty
|
2 (8), 2
|
0 (0), 0
|
Headache
|
6 (25), 10
|
1 (4), 1
|
Migraine
|
1 (4), 1
|
0 (0), 0
|
Speech disorders
|
1 (4), 1
|
0 (0), 0
|
Feeling of drunkenness
|
2 (8), 5
|
0 (0), 0
|
Sleep difficulty
|
1 (4), 1
|
2 (8), 2
|
Multiple sclerosis aggravated
|
1 (4), 1
|
2 (8), 2
|
Musculoskeletal system
|
9 (38), 13
|
2 (8), 2
|
Myalgia
|
6 (25), 7
|
1 (4), 1
|
Muscle weakness
|
3 (13), 3
|
1 (4), 1
|
Limb heaviness
|
1 (4), 2
|
0 (0), 0
|
Distortion of wrist
|
1 (4), 1
|
0 (0), 0
|
Gastrointestinal disorders
|
5 (21), 7
|
4 (17), 8
|
Mouth dryness
|
3 (13), 3
|
0 (0), 0
|
Nausea
|
3 (13), 4
|
4 (17), 5
|
Abdominal pain
|
0 (0), 0
|
1 (4), 3
|
Cardiovascular disorders
|
4 (17), 8
|
2 (8), 4
|
Palpitations
|
4 (17), 8
|
2 (8), 4
|
Psychiatric disorders
|
3 (13), 4
|
1 (4), 1
|
Euphoria
|
3 (13), 3
|
0 (0), 0
|
Hyperactivity
|
1 (4), 1
|
0 (0), 0
|
Nervousness
|
0 (0), 0
|
1 (4), 1
|
Endocrine disorders
|
1 (4), 2
|
0 (0), 0
|
Hot flushes
|
1 (4), 2
|
0 (0), 0
|
Vision disorders
|
0 (0), 0
|
1 (4), 1
|
Diplopia
|
0 (0), 0
|
1 (4), 1
|
Whole body
|
4 (17), 5
|
2 (8), 2
|
Anorexia
|
1 (4), 1
|
0 (0), 0
|
Weight decrease
|
1 (4), 1
|
0 (0), 0
|
Fever
|
0 (0), 0
|
1 (4), 1
|
Chills
|
1 (4), 1
|
0 (0), 0
|
Upper airway infection
|
1 (4), 1
|
1 (4), 1
|
Tenderness in nose
|
1 (4), 1
|
0 (0), 0
|
Total
|
23 (96)**, 100
|
11 (46), 38
|
Adverse event in first treatment week
|
21 (88)** , 50
|
8 (33), 23
|
Adverse event in last treatment week
|
10 (42), 15
|
5 (21), 7
|
Severe adverse event
|
3 (13), 3
|
1 (4), 1
|
|
