Cargando…

Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review

OBJECTIVE: To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine reporting of serious adverse events in drug trials published o...

Descripción completa

Detalles Bibliográficos
Autores principales:	Madi, Karima, Flumian, Clara, Olivier, Pascale, Sommet, Agnès, Montastruc, François
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2023
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10537984/ https://www.ncbi.nlm.nih.gov/pubmed/37779893 http://dx.doi.org/10.1136/bmjmed-2022-000352

Ejemplares similares

Increased reporting of venous and arterial thromboembolic events reported with tixagevimab–cilgavimab for coronavirus disease 2019
por: Montastruc, François, et al.
Publicado: (2023)

Cancer Risk of Anti-TNF-α at Recommended Doses in Adult Rheumatoid Arthritis: A Meta-Analysis with Intention to Treat and per Protocol Analyses
por: Moulis, Guillaume, et al.
Publicado: (2012)

COVID-19 vaccines: A perspective from social pharmacology
por: Montastruc, Jean-Louis, et al.
Publicado: (2021)

Laboratory Monitoring of Patients Treated with Antihypertensive Drugs and Newly Exposed to Non Steroidal Anti-Inflammatory Drugs: A Cohort Study
por: Fournier, Jean-Pascal, et al.
Publicado: (2012)

Serious Neurological Adverse Events of Ceftriaxone
por: Lacroix, Clémence, et al.
Publicado: (2021)

Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns
por: Touafchia, Anthony, et al.
Publicado: (2021)

Adverse drug reactions and ivermectin in COVID-19
por: Montastruc, Jean-Louis
Publicado: (2022)

Systematic Analysis of Adverse Event Reports for Sex Differences in Adverse Drug Events
por: Yu, Yue, et al.
Publicado: (2016)

Which Adverse Events Are Related to Health Care during Hospitalization in Elderly Inpatients?
por: Dupouy, Julie, et al.
Publicado: (2013)

Quality of reporting in systematic reviews of adverse events: systematic review
por: Zorzela, Liliane, et al.
Publicado: (2014)

A High Postoperative Atropinic Burden is Associated with Postoperative Delirium in Elderly Patients with Hip Fracture: Results of the Prospective, Observational, ATROPAGE Trial
por: Ferré, Fabrice, et al.
Publicado: (2022)

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial
por: Defer, Gilles, et al.
Publicado: (2018)

Quality of adverse event reporting in clinical trials of remdesivir in patients with COVID-19
por: Kow, Chia Siang, et al.
Publicado: (2020)

Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov
por: Su, Eric Wen, et al.
Publicado: (2017)

Serious adverse drug reactions with hydroxychloroquine: a pharmacovigilance study in Vigibase®
por: Montastruc, Jean-Louis, et al.
Publicado: (2020)

Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database
por: Berthet, Stephanie, et al.
Publicado: (2011)

The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors
por: Karimian, Zahra, et al.
Publicado: (2020)

Categorisation of Pharmaceutical Adverse Events Using the Japanese Adverse Drug Event Report Database: Characteristic Adverse Drug Events of the Elderly Treated with Polypharmacy
por: Negishi, Akio, et al.
Publicado: (2020)

Adverse Event Reporting Quality in Cancer Clinical Trials Evaluating Immune Checkpoint Inhibitor Therapy: A Systematic Review
por: Wang, Yuhong, et al.
Publicado: (2022)

Hyperglycemic adverse events following antipsychotic drug administration in spontaneous adverse event reports
por: Kato, Yamato, et al.
Publicado: (2015)

Exploring adverse drug events at the class level
por: Winnenburg, Rainer, et al.
Publicado: (2015)

A population-based study of self-reported adverse drug events among Lebanese outpatients
por: Ramia, Elsy, et al.
Publicado: (2021)

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database
por: Noda, Aoi, et al.
Publicado: (2020)

Characteristics of pediatric adverse drug reaction reports in the Japanese Adverse Drug Event Report Database
por: Noda, Aoi, et al.
Publicado: (2020)

Standardizing adverse drug event reporting data
por: Wang, Liwei, et al.
Publicado: (2014)

Development of an adverse drug event network to predict drug toxicity
por: Wu, Qier, et al.
Publicado: (2020)

Completeness of adverse drug reactions reports of the Saudi adverse event reporting system
por: Alshammari, Thamir M., et al.
Publicado: (2015)

Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study
por: Chouchana, Laurent, et al.
Publicado: (2021)

Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems
por: Han, Nayoung, et al.
Publicado: (2021)

Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database
por: Yamashiro, Kaito, et al.
Publicado: (2022)

Quality of adverse event reporting in phase III randomized controlled trials of breast and colorectal cancer: A systematic review
por: Komorowski, Adam S., et al.
Publicado: (2020)

Reporting of adverse events associated with spinal manipulation in randomised clinical trials: an updated systematic review
por: Gorrell, Lindsay M, et al.
Publicado: (2023)

Visualization of Kinase Inhibition-Related Adverse Events Using the Japanese Adverse Drug Event Report Database
por: Mizuno, Takahito, et al.
Publicado: (2021)

Adverse Event Reporting in Randomized Clinical Trials for Multiple Myeloma
por: Najjar, Mimi, et al.
Publicado: (2023)

Reporting adverse drug events to the Therapeutic Goods Administration
por: Martin, Jennifer H, et al.
Publicado: (2021)

Challenges in Coding Adverse Events in Clinical Trials: A Systematic Review
por: Schroll, Jeppe Bennekou, et al.
Publicado: (2012)

Serious Adverse Drug Events Reported to the FDA: Analysis of the FDA Adverse Event Reporting System 2006-2014 Database
por: Sonawane, Kalyani B., et al.
Publicado: (2018)

Treatment‐related adverse events of antibody–drug conjugates in clinical trials: A systematic review and meta‐analysis
por: Zhu, Youwen, et al.
Publicado: (2022)

Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials
por: Federer, Callie, et al.
Publicado: (2016)

Interactions between Medical Residents and Drug Companies: A National Survey after the Mediator® Affair
por: Montastruc, François, et al.
Publicado: (2014)

Cannot write session to /tmp/vufind_sessions/sess_nm3f0o2sbdl0lgsd4dmon5i7bm