Rowan, Christopher G.
Agiro, Abiy
Chan, K. Arnold
Colman, Ellen
White, Katie
Desai, Pooja
Dwyer, Jamie P.
Funding for this research was provided by:
AstraZeneca
Article History
Received: 14 December 2023
Accepted: 6 March 2024
First Online: 30 April 2024
Declarations
:
: Christopher G. Rowan was paid by TriNetX, LLC as an observational scientist to design and execute this study and is a paid consultant for Harvard Pilgrim Health Care Institute and Puma Biotech. Abiy Agiro, Ellen Colman, and Pooja Desai are employees and stockholders of AstraZeneca. K. Arnold Chan and Katie White are employees of TriNetX, LLC. The study described in this manuscript was conducted as part of their employment responsibilities at TriNetX, LLC. The authors were compensated by TriNetX, LLC for their contributions to the design, data collection, analysis, and interpretation of the study findings presented herein. The funding for this study was provided by AstraZeneca. Jamie P. Dwyer has acted as a scientific consultant for AstraZeneca and received fees from AstraZeneca for the conduct of this study; has received fees from Sanofi and CSL Behring as part of a steering committee; has received fees from Novo Nordisk for outcome adjudication for a clinical trial; has received fees from Boehringer Ingelheim and Lilly for study design; and has received personal fees from Bayer, CinCor, Caladrius Biosciences, Inversago, GlaxoSmithKline LLC, and ProKidney.
: This study used only patient data that were de-identified in compliance with the standard defined in section §164.514(a) of the Health Insurance Portability and Accountability Act (HIPAA) privacy rule. All data were collected during routine clinical practice prior to access to the final data cut from the TriNetX Dataworks-USA Network database; all study data were de-identified and no patient identifiers were available to the study investigators. AstraZeneca did not access or license data from TriNetX for the conduct of this study. The study was not classified as research involving human subjects (under the Code of Federal Regulations title 45 §46.101) and was therefore exempt from institutional review board approval or requirement for informed consent from individual patients. This study was conducted in accordance with the Declaration of Helsinki of 1964 and its later amendments.