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Article History

Received: 21 November 2020

Accepted: 21 February 2021

First Online: 24 March 2021

Declarations

:

: The study was conducted in accordance with the Guidelines for Good Pharmacoepidemiology Practice, Good Practices for Outcomes Research issued by the International Society for Pharmacoeconomics and Outcomes Research, and Good Practices for Real-world Data Studies of Treatment and/or Comparative Effectiveness. This study was exempt from institutional review board approval as the study was retrospective, non-interventional, and used anonymized data provided by Flatiron. The Flatiron real-world dataset is covered under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) through Business Associate Agreements with every provider in the Flatiron network. These agreements authorize Flatiron to collect and de-identify patient-level structured and unstructured data to create de-identified datasets for research purposes. Processed data are de-identified according to either the Safe Harbor or Expert Determination method as outlined in HIPAA Section 164.514(b). When using the Expert Determination method, Flatiron employs a third-party expert to design the de-identification methodology and certify that the dataset is de-identified. Only de-identified data are delivered to clients.

: Not applicable

: ADeM has received consulting fees from Pfizer Inc. and Context Therapeutics, honoraria from Pfizer Inc., and research funding from Pfizer, Novartis, Menarini Biosystems, Calithera, Incyte, and Genetech. MC has received consulting fees from Novartis, Merus, CytoDyn, Sermonix, and G1 Therapeutics; honoraria from Pfizer Inc.; and research funding from Pfizer Inc., Novartis, Merus, Lilly, and G1 Therapeutics. AB has received consulting fees from Pfizer Inc. JM is a former employee of and owns stock in Pfizer Inc. RML has received research funding from Pfizer Inc., Novartis, Eli Lilly, GlaxoSmithKline, and Zentalis and consulting fees from Pfizer Inc. and Novartis. MAT has received research funding from Pfizer Inc. and Genentech, honorarium from MJH Life Sciences, and advisory fees from the Centers for Disease Control. HSR has received research funding from Plexxikon, Macrogenics, OBI Pharma, Eisai, Pfizer, Novartis, Eli Lilly, Genentech, and Merck. RSF has received consulting fees and honoraria from Pfizer Inc. and research funding from Pfizer Inc., Eli Lilly, and Novartis. XL, LMcR, and BE are employees of and own stock in Pfizer Inc.