Fox, Robert J.
Mehta, Rina
Pham, Timothy
Park, Julie
Wilson, Kathleen
Bonafede, Machaon
Article History
Received: 30 June 2021
Accepted: 27 May 2022
First Online: 7 June 2022
Declarations
:
: This study is based on information from an existing database and is exempt from review or approval by institutional review boards, ethics committees, or informed consent. Patient data were de-identified and met the Health Insurance Portability and Accountability Act of 1996 requirements to ensure patient anonymity. The data in this study did not involve the interaction or interview with any subjects and as such does not fall within the regulatory definitions of research involving human subjects. An Observational Protocol Review Committee at Bristol Myers Squibb approved the study protocol prior to study initiation. All methods were performed in accordance with International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP) and applicable regulatory requirements, including the principles of the Declaration of Helsinki.
: Not applicable.
: TP is an employee of Bristol Myers Squibb. RM was an employee of Celgene, a Bristol Myers Squibb company, at the time the study was conducted. JP and KW are employed by IBM Watson Health, which received funding from Bristol Myers Squibb to conduct this study. MB was employed by IBM Watson Health at the time the study was conducted. RJF is a paid consultant of Bristol Myers Squibb and has received personal consulting fees from AB Science, Actelion, Biogen, EMD Serono, Genentech, Immunic, Novartis, Sanofi, Teva, and TG Therapeutics; served on advisory committees for Actelion, Biogen, Immunic, Novartis, and Sanofi; and received clinical trial contract and research grant funding from Biogen and Novartis.