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Dose withdrawn permanently | 21 (8.0%) | 37 (14.1%) | 1 (0.4%) | 59 (22.5%) |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)
The authors thank the participants in this study and the medical professionals and clinic staff for collection of data. The authors also thank Youri Drozd and Charlotte Bastin for technical support.
LR, MFA, and EP: Conceptualization. LR: Data curation, Formal analysis, Writing—original draft. MFA: Resources. EP: Supervision. MFA, EP, CS, AW, and DD: Writing—review and editing.
All authors have a relationship with Santé Cannabis, a medical cannabis clinic and research centre based in Montreal, Québec, Canada. Santé Cannabis operates within the public healthcare system, patients do not pay fees to receive care at the clinic. Santé Cannabis does not sell, or receive financial benefit from the sale of medical cannabis.
The registry, from which the submitted data is extracted, was approved by the McGill University Faculty of Medicine and Health Sciences Ethics Committee (ID A07-E47-20B/20-07-004). The study was conducted in accordance with the Declaration of Helsinki.
Informed consent to participate in the study was obtained from all participants.
Not applicable.
The datasets for this manuscript are not publicly available because they are not part of a public repository. Requests for accessing the datasets should be directed to Lucile Rapin, lrapin@santecannabis.ca.
Not applicable.
© The Author(s) 2023.