Dizdarevic, Sabina http://orcid.org/0000-0002-6715-3744
Petersen, Peter Meidahl
Essler, Markus
Versari, Annibale
Bourre, Jean-Cyril
la Fougère, Christian
Valdagni, Riccardo
Paganelli, Giovanni
Ezziddin, Samer
Kalinovský, Ján
Bayh, Inga
Du, Yong
Funding for this research was provided by:
Bayer
Article History
Received: 23 November 2018
Accepted: 2 January 2019
First Online: 12 January 2019
Compliance with ethical standards
:
: S Dizdarevic provides occasional consultancy to Bayer and has received occasional conference/travel sponsorship; P Meidahl Peterson reports fees from Bayer for advisory board participation; C la Fougère reports fees from Bayer for Advisory Board participation; J Kalinovsky and I Bayh are salaried employees of Bayer; Y Dong reports receiving financial support from Bayer for educational activities. All other authors have no conflicts of interest to disclose.
: This study is an observational study where radium-223 is prescribed in accordance with the terms of the marketing authorization. There is no assignment of a patient to a particular therapeutic strategy. The treatment decision falls within current practice, and the prescription of the medicines is clearly separated from the decision to include the patient in the study. The study protocol was reviewed and approved by an independent ethics committee or institutional review board at each site. The study is being conducted in accordance with guidelines and regulations of the European Medicines Agency, the Food and Drug Administration, and applicable local laws and regulations. In addition, guidelines on good pharmacovigilance practices are being followed.
: All patients provided written informed consent.