Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.

"Disclosure VLR III reports research grants to his institution from the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH); consulting fees from Entasis, Takeda, and Urovant Sciences; and participation on the FDA Drug Safety and Risk Management Advisory Committee. NMC reports research funding from FDA via a Department of Health and Human Services (HHS) contract during the conduct of the study and funding from HPHCI (a non-profit organization that conducts work for government and private organizations, including pharmaceutical companies) outside the submitted work. RAH reports grants from FDA, NIH, and Merck. AMP reports royalties from UpToDate (including for an article on anticoagulation), consulting fees via advisory board from BioMarin LLC outside the submitted work, and speaker honorarium from the American Society of Hematology. DAD reports stock options in CVS Health. JLK reports unrelated research grants to her institution from Vir Biotechnology, Pfizer, Novartis, and the Centers for Disease Control and Prevention. PRR reports unrelated research grants to his institution from Chiesi, UCB, Amgen, Johnson & Johnson, Innovative Medicines Initiative, and the European Medicines Agency. KV reports unrelated research grants to her institution from Chiesi, UCB, Amgen, Johnson & Johnson, and the European Medicines Agency. DPA reports research grants to his institution from Amgen, Chiesi-Taylor, Lilly, Janssen, Novartis, and UCB Biopharma as well as consulting fees from Astra Zeneca and UCB Biopharma. The authors report no other conflicts of interest in this work."

"The Canadian Network for Observational Drug Effect Studies (CNODES) is a core network partner of CoLab and funded by CADTH (grant number C222 360). At the time of this study, CNODES was a collaborating center of the Drug Safety and Effectiveness Network (DSEN) and funded by the Canadian Institutes of Health Research (CIHR, grant numbers DSE-11856 and DSE-146021). Health Canada had no role in data collection, management, or analysis. This project was also supported by Task Order 75F40119F19001 under Master Agreement 75F40119D10037 from the US Food and Drug Administration (FDA). The FDA approved the study protocol, including statistical analysis plan, and reviewed and approved this manuscript. Coauthors from the FDA participated in the result interpretation and in the preparation and decision to submit the manuscript for publication. The FDA had no role in data collection, management, or analysis. The European portion of this project was supported by the European Medicines Agency (EMA) as a specific contract with Erasmus Medical Center, Rotterdam, the Netherlands, under the framework contract number EMA/2018/21/PE, Lot 3. The EMA approved the EU study protocol and reviewed and approved this manuscript. The EMA had no role in data collection, management, or analysis. Additional support was provided by the UK NIHR Oxford Biomedical Research Centre."