Updates are available Correction dated 2021-10-15

Article History

Accepted: 21 June 2021

First Online: 2 August 2021

Change Date: 15 October 2021

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s11523-021-00847-w

Declarations

:

: Pfizer Inc (NCT04176354).

: Adam Brufsky has received consulting fees from Pfizer Inc, AstraZeneca, Sanofi, Eli Lilly, and Novartis. Xianchen Liu, Benjamin Li, and Lynn McRoy are employees of and own stock in Pfizer Inc. Rachel M. Layman’s institution has received research funding from Pfizer Inc, Novartis, and Eli Lilly; and Dr. Layman has participated in advisory boards for Pfizer Inc, Eli Lilly, and Novartis.

: This study is exempt from institutional review board approval because it is retrospective, non-interventional, and used anonymized data provided by Flatiron.

: Not applicable.

: Not applicable.

: Upon request, and subject to certain criteria, conditions, and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the USA and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer. The data on the real-world cohort that support the findings of this study have been originated by Flatiron Health, Inc and were purchased by Pfizer from Flatiron Health Inc for the purpose of this research. Access to the de-identified data set is subject to a contractual agreement with Flatiron Health; for data access, interested researchers should contact DataAccess@flatiron.com. A licensing agreement is legally required prior to sharing these data in order to safeguard sensitive patient information, and to ensure proper deidentification and compliance with applicable restrictions and requirements under HIPAA.

: Not applicable.

: All authors contributed to the conception and design of the study, provided study materials, data interpretation and analysis, drafted the manuscript, and/or critically revised the manuscript for intellectual contribution. BL collected and assembled data. All authors approved the final version of the manuscript for submission.