J Zong was responsible for the individual studies’ conception and design. ZP Vassilev, M Soriano Gabarró, JA Kaye, CW Saltus, O Riedel, O Scholle, J Mehtälä, P Korhonen, E Garbe and J Zong were responsible for data acquisition and analysis, as well as drafting and revision of the manuscript.

Acknowledgments

The authors would like to thank AOK Bremen/Bremerhaven and Die Techniker (TK) that provided data for this study; NCI, which provided access to linked SEER-Medicare data; and PCBaSe, which provided data from the Swedish National Health Register linkage. The authors would also like to thank H Khanfir for assistance in analyzing the Swedish data and B Calingaert for analyzing the US data.

Disclaimer

The main results and sensitivity analyses of the US study have previously been published in references [26] and [29]. The main results and sensitivity analyses of the Swedish study have previously been published in reference [25].

Data & protocol sharing statement

Individual participant data that underlie the results reported in this article will not be shared. In Germany, use of personal data is protected by the Federal Data Protection Act, and particularly the use of claims data for research is regulated by the Code of Social Law. Researchers have to apply for a project-specific permit from the statutory health insurance providers as well as their governing authorities. The use of the data on which this publication is based was only allowed for BIPS employees within the framework of the specified project and limited to a predefined time span. Researchers who want to access the data on which this publication is based need to ask for new approval by the statutory health insurance providers and their respective authorities.

Individual participant data from the Swedish study cannot be directly shared per the data use agreement between EPID Research and Uppsala County Council. The Steering Group of the National Prostate Cancer Register coordinates research projects within the PCBaSe framework and can be contacted in order to submit a request for data. For further information, see http://npcr.se/npcr/medarbetare/

Individual participant data from the US study cannot be shared per the data use agreement between RTI-HS and NCI.

The three study protocols for each of the cohorts are publicly available in the EU PAS Register of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), under EU PAS Register numbers EUPAS12665 (GePaRD), EUPAS33448 (PCBaSe) and EUPAS13602 (SEER program).

Financial & competing interests disclosure

O Riedel and O Scholle are current employees and E Garbe is a former employee of the Leibniz Institute for Prevention Research and Epidemiology – BIPS; J Mehtälä and P Korhonen are employees of EPID Research Oy; and C Saltus and J Kaye are employees of RTI Health Solutions, all of which received funding from Bayer AG to conduct these studies. BIPS, EPID Research and RTI Health Solutions designed their respective studies, acquired the data, conducted the analyses, interpreted study results and decided to submit the article for publication with input from Bayer. Z Vassilev, J Zong and M Soriano-Gabarró are employees of Bayer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The studies and this report were funded by Bayer AG; claimed by both brand and generic name.

We thank Katherine Mezic, PhD (Chameleon Communications International with funding from Bayer AG) for editorial assistance in the preparation of this report.

Ethical conduct of research

The authors state that the studies within this work were conducted using data from the GePaRD (Germany), PCBaSe (Sweden; with data use agreement on 28 November 2016) and NCI’s SEER program (USA). Studies were guided by data use agreements between the statutory health insurance providers, the respective governing authorities and the Leibniz Institute for Prevention Research and Epidemiology – BIPS; between the PCBaSE and EPID Research Oy; and between NCI and RTI Health Solutions. According to the Ethics Committee of the University of Bremen, studies based on GePaRD are exempt from institutional review board review. Swedish and US studies were reviewed by their respective institutional review boards, receiving exemptions on 24 October 2016, and 23 February 2016.

Open access

This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/

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