ADRs severity, causality, outcome, and action taken criteria
ADR description criteria | CBD-dominant [N (%)] | THC-CBD balanced [N (%)] | THC-dominant [N (%)] | Total [N (%)] |
---|---|---|---|---|
Total ADRs | 112 (42.7%) | 148 (56.5%) | 2 (0.8%) | 262 |
Severity | ||||
Mild | 86 (32.8%) | 99 (37.8%) | 2 (0.8%) | 187 (71.4%) |
Moderate | 24 (9.2%) | 44 (16.8%) | 0 (0%) | 68 (26.0%) |
Severe | 2 (0.8%) | 5 (1.9%) | 0 (0%) | 7 (2.7%) |
Causality | ||||
Definitely related | 6 (2.3%) | 10 (3.8%) | 0 (0%) | 16 (6.1%) |
Possibly related | 65 (24.8%) | 81 (30.9%) | 1 (0.4%) | 147 (56.1%) |
Probably related | 37 (14.1%) | 54 (20.6%) | 1 (0.4%) | 92 (35.1%) |
Unlikely related | 4 (1.5%) | 3 (1.1%) | 0 (0%) | 7 (2.7%) |
Outcome | ||||
Not recovered | 17 (6.5%) | 22 (8.4%) | 0 (0%) | 39 (14.9%) |
Recovered | 45 (17.2%) | 72 (27.5%) | 2 (0.8%) | 119 (45.4%) |
Recovering | 41 (15.6%) | 43 (16.4%) | 0 (0%) | 82 (32.1%) |
Stabilized | 8 (3.1%) | 11 (4.2%) | 0 (0%) | 19 (7.3%) |
Unknown | 1 (0.4%) | 0 (0%) | 0 (0%) | 1 (0.4%) |
Action taken | ||||
Dose decreased | 26 (9.9%) | 32 (12.2%) | 1 (0.4%) | 59 (22.5%) |
Dose delayed | 6 (2.3%) | 3 (1.1%) | 0 (0%) | 9 (3.4%) |
Dose increased | 19 (7.3%) | 9 (3.4%) | 0 (0%) | 28 (10.7%) |
Dose interrupted or discontinued temporarily | 19 (7.3%) | 25 (9.5%) | 0 (0%) | 44 (16.8%) |
Dose not changed | 21 (8.0%) | 39 (14.9%) | 0 (0%) | 60 (22.9%) |
Dose withdrawn permanently | 21 (8.0%) | 37 (14.1%) | 1 (0.4%) | 59 (22.5%) |
Unknown | 0 (0%) | 3 (1.1%) | 0 (0%) | 3 (1.1%) |
N (%): the number of people under current conditions (percentage of people under current conditions)