Table 3 AEs by treatment and prior experience of cannabis (where n >/= 10)
Body system | Preferred term | Sativex® | Placebo | OR (95% CI) | |
|---|---|---|---|---|---|
n | n (%) | n (%) | |||
Nervous system disorders | Dizziness | PC | 32 (26%) | 13 (12%) | 2.7 (1.3 to 5.4) |
n = 150 | No PC | 84 (35%) | 21 (11%) | 4.33 (2.6 to 7.3) | |
Headache | PC | 9 (7%) | 14 (13%) | 0.55 (0.2 to 1.3) | |
n = 57 | No PC | 21 (9%) | 13 (7%) | 1.31 (0.6 to 2.7) | |
Somnolence | PC | 17 (14%) | 3 (3%) | 5.8 (1.7 to 20.5) | |
n = 45 | No PC | 19 (8%) | 6 (3%) | 2.6 (1.0 to 6.7) | |
Muscle spasticity | PC | 2 (2%) | 2 (2%) | 0.9 (0.1 to 6.6) | |
n= 33 | No PC | 17 (7%) | 12 (6.3%) | 1.1 (0.5 to 2.4) | |
Balance disorder | PC | 6 (5%) | 3 (2.7%) | 1.9 (0.5 to 7.6) | |
n = 20 | No PC | 8 (3%) | 3 (2%) | 2.2 (0.6 to 8.2) | |
Disturbance in attention | PC | 7 (6%) | 0 | ||
n = 19 | No PC | 12 (5%) | 0 | ||
Dysgeusia | PC | 3 (3%) | 1 (1%) | 2.8 (0.3 to 27.0) | |
n= 18 | No PC | 13 (5%) | 1 (0.5%) | 10.8 (1.4 to 83.6) | |
MS relapse | PC | 0 | 2 (1.8%) | ||
n = 17 | No PC | 8 (3%) | 7 (4%) | 0.9 (0.3 to 2.5) | |
Dysarthria | PC | 5 (4%) | 0 | ||
n = 13 | No PC | 2 (3%) | 2 (1%) | 2.4 (0.5 to 12.1) | |
Psychiatric disorders | Disorientation | PC | 9 (7%) | 1 (1%) | 8.8 (1.1 to 70.3) |
n = 21 | No PC | 10 (4%) | 1 (0.5%) | 8.2 (1.0 to 64.9) | |
Depression | PC | 5 (4%) | 3 (3%) | 1.5 (0.4 to 6.6) | |
n = 19 | No PC | 8 (3%) | 3 (2%) | 2.2 (0.6 to 8.2) | |
Euphoria | PC | 3 (3%) | 3 (3%) | 0.9 (0.2 to 4.6) | |
n = 13 | No PC | 4 (2%) | 3 (2%) | 1.1 (0.2 to 4.8) | |
Insomnia | PC | 0 | 1 (1%) | ||
n = 10 | No PC | 4 (2%) | 5 (3%) | 0.6 (0.2 to 2.4) | |
General disorders | Fatigue | PC | 17 (14%) | 9 (8%) | 1.8 (0.8 to 4.3) |
n = 107 | No PC | 50 (21%) | 31 (17%) | 1.4 (0.8 to 2.2) | |
Application site pain | PC | 6 (5%) | 6 (6%) | 0.9 (0.3 to 2.9) | |
n = 34 | No PC | 12 (5%) | 10 (5%) | 0.9 (0.4 to 2.2) | |
Asthenia | PC | 9 (7%) | 7 (6%) | 1.2 (0.4 to 3.3) | |
n = 45 | No PC | 22 (9%) | 7 (4%) | 2.6 (1.0 to 6.8) | |
Feeling abnormal | PC | 5 (4%) | 1 (1%) | 4.7 (0.5 to 40.9) | |
n = 12 | No PC | 5 (2%) | 1 (1%) | 4 (0.5 to 34.8) | |
Feeling drunk | PC | 3 (3%) | 0 | ||
N = 11 | No PC | 8 (3%) | 0 | ||
GastroIntestinal Disorders | Oral discomfort | PC | 12 (10%) | 10 (9%) | 1.1 (0.5 to 2.7) |
n = 45 | No PC | 13 (5%) | 10 (5%) | 1.0 (0.4 to 2.4) | |
Nausea | PC | 12 (10%) | 8 (7%) | 1.4 (0.6 to 3.6) | |
n = 67 | No PC | 32 (13%) | 15 (8%) | 1.8 (0.9 to 3.4) | |
Dry mouth | PC | 6 (5%) | 6 (6%) | 0.9 (0.3 to 2.9) | |
n = 37 | No PC | 21 (9%) | 4 (2%) | 4.5 (1.5 to 13.2) | |
Diarrhoea | PC | 8 (7%) | 7 (6%) | 1.0 (0.4 to 3.0) | |
n = 30 | No PC | 12 (5%) | 3 (2%) | 3.3 (0.9 to 11.8) | |
Vomiting | PC | 2 (2%) | 1 (1%) | 1.8 (0.2 to 20.5) | |
n = 16 | No PC | 7 (3%) | 6 (3%) | 0.9 (0.3 to 2.8) | |
Constipation | PC | 5 (4%) | 3 (3%) | 1.5 (0.4 to 6.6) | |
n = 15 | No PC | 7 (3%) | 0 | ||
Dyspepsia | PC | 1 (1%) | 2 (2%) | 0.5 (0.0 to 5.0) | |
n = 14 | No PC | 7 (3%) | 4 (2%) | 1.4 (0.4 to 4.9) |