Evidence map›Paper›PMID 37996777›Full record

ArticleDrug safety2024

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry.

Yasmina Hachem, Yola Moride, Anne-Marie Castilloux, Genaro Castillon, Maja Kalaba, Andrée Néron, Rihab Gamaoun, Marc O Martel, Pierre Beaulieu, Mark Ware and 1 more

Abstract read
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In one paragraph

Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Yasmina HachemMedical Cannabis Program in Oncology, McGill University Health Center, Montréal, QC, Canada.
Yola MorideCenter for PharmacoEpidemiology and Treatment Science, Rutgers, The State University of New Jersey, New Brunswick, NJ, USA. morideyo@ifh.rutgers.edu.ORCID 0000-0002-8753-2274
Anne-Marie CastillouxYolaRX Consultants, Montréal, QC, Canada.
Genaro CastillonYolaRX Consultants, Montréal, QC, Canada.
Maja KalabaCanopy Growth Corporation, Smiths Falls, ON, Canada.
Andrée NéronBureau d'évaluation médicale (Consultant on request in medical cannabis-related pharmacological assessments and needs for injured workers), Québec City, QC, Canada.
Rihab GamaounResearch Institute of the McGill University Health Centre, Montréal, QC, Canada.
Marc O MartelDepartment of Anesthesiology, Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montréal, QC, Canada.
Pierre BeaulieuDépartement de pharmacologie et physiologie/Département d'anesthésiologie et de médecine de la douleur, Faculté de médecine de l'Université de Montréal, Montréal, QC, Canada.
Mark WareAlan Edwards Pain Management Unit, McGill University Health Center, Montréal, QC, Canada.
Antonio ViganoMedical Cannabis Program in Oncology, McGill University Health Center, Montréal, QC, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPublished data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are lacking. This study aimed to describe adverse events (AEs) reported across three years following MC initiation.

methodsThe Quebec Cannabis Registry (QCR) was a prospective registry of adults enrolled through participating physicians when they initiated MC between May 2015 and October 2018. Follow-up ended at MC discontinuation, loss to follow-up, three years, or end of data collection (May 2019). Data were collected at baseline and at follow-up visits every three months for the first two years, then once in the third year. Physicians filled adverse event (AE) reports, which were coded using MedDRA

resultsA total of 2991 patients were enrolled (mean age 50.9 years, 50.2% females). During follow-up, 108 patients (3.6%) experienced moderate or severe AEs, yielding 111 AE reports (three patients had two reports) and 214 AEs (average 1.9 AEs per report). Mild AEs were recorded as a reason for MC discontinuation for nine patients, but no AE reports were available. The most common PTs for ingested MC (62 reports) were dizziness (12.9%), nausea (11.3%), somnolence (9.7%), and vomiting (8.1%), and for inhaled MC (23 reports), headache (13.0%) was the most common. The most frequent PTs associated with tetrahydrocannabinol (THC)-dominant MC (25 reports) were dizziness and somnolence (12.0% each); for cannabidiol (CBD)-dominant MC (20 reports), vomiting (20.0%) was most common; and dizziness (17.2%), nausea (13.8%), somnolence (10.3%), and headache (8.6%) were the most frequent for balanced MC (58 reports).

conclusionNo new safety concerns were identified relative to the published literature, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals. Further work identifying and managing risk factors for AEs is warranted to maintain a favorable benefit-risk balance for MC.

Indexed as

CannabisAdultDizzinessFemaleHeadacheHumansMaleMiddle AgedNauseaQuebecRegistriesSleepinessVomiting

Identifiers

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.