Maximum frequency*, intensity and outcome of adverse events—safety set
| Category | Cannabis extract (N=143) | Placebo (N=134) |
| n (%) | n (%) | |
| Frequency† | ||
| Dizziness | 89 (46.2) | 10 (6.7) |
| Urinary tract infection | 34 (15.4) | 19 (11.9) |
| Dry mouth | 34 (23.1) | 10 (7.5) |
| Headache | 22 (11.2) | 20 (11.9) |
| Asthenia | 25 (13.3) | 11 (8.2) |
| Fatigue | 25 (14.0) | 9 (6.0) |
| Intensity‡ | ||
| Mild | 347 (55.3) | 177 (61.2) |
| Moderate | 252 (40.1) | 102 (35.3) |
| Severe | 28 (4.5) | 10 (3.5) |
| Missing | 1 (0.2) | 0 (0.0) |
| Outcome‡ | ||
| Recovered | 450 (71.7) | 181 (62.6) |
| Recovered with sequelae | 4 (0.6) | 5 (1.7) |
| Ongoing | 165 (26.3) | 97 (33.6) |
| Unknown | 9 (1.4) | 6 (2.1) |
| Total number of events | 628 (100.0) | 289 (100.0) |
↵* Adverse events occurring in at least 10% of all patients.
↵† Percentages of adverse event frequencies are calculated as proportions of all patients in specified treatment group (=N).
↵‡ Percentages of adverse event intensities and outcomes are based on total number of events in specified treatment group.
%, percentages; n, number of events in specified category; N, number of patients in specified treatment group.