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Authors
Harrold, Leslie R. https://orcid.org/0000-0002-0170-2747
Bingham, Clifton O.
Pope, Janet E. https://orcid.org/0000-0003-1479-5302
O’Brien, Jacqueline
Moore, Page C.
Roberts-Toler, Carla
Yu, Miao
Sweet, Lindsay L.
Shelbaya, Ahmed https://orcid.org/0000-0003-1028-5866
Masri, Karim R. https://orcid.org/0000-0002-2178-9747
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Funding
Funding for this research was provided by:
CorEvitas, LLC
Pfizer
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Article History
Received: 25 May 2024
Revised: 18 October 2024
Accepted: 15 November 2024
First Online: 20 December 2024
Declarations
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: This study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice. All participating investigators were required to obtain full institutional review board (IRB) board approval for conducting non-interventional research involving human patients with a limited dataset. Sponsor approval and continuing review were obtained from the New England Independent Review Board (no. 120160610). For academic investigative sites that did not receive authorization to use the central IRB, full board approval was obtained from the respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC prior to the initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization prior to participating in the study.
: LRH has acted as a consultant for AbbVie, Bristol Myers Squibb, Pfizer Inc, and Roche, is a member of a speakers' bureau for Bristol Myers Squibb, and is an employee and shareholder of CorEvitas, LLC.COB has received grant support from Bristol Myers Squibb and has acted as consultant for AbbVie, Eli Lilly, Janssen, Pfizer Inc, and Sanofi.JEP has received grant and/or research support from AbbVie, Fresenius Kabi, Mallinckrodt, Pfizer Inc, and Seattle Genetics, has acted as consultant for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, EMERALD, Fresenius Kabi, GSK, Janssen, Mallinckrodt, Mitsubishi Tanabe, Novartis, Organon, Pfizer Inc, Sandoz, Samsung, and Viatris, and has been a speaker/advisory board member for AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Fresenius Kabi, GSK, Janssen, Novartis, Organon, Pfizer Inc, Sandoz, UCB, and Viatris,JOB, PCM, and MY are employees of CorEvitas, LLC.CR-T was an employee of CorEvitas, LLC at the time of the analysis, and is currently affiliated with Harvard School of Public Health.LLS and KRM were employees and shareholders of Pfizer Inc at the time of the analysis.AS is an employee and shareholder of Pfizer Inc.
