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Article History

First Online: 12 July 2019

Compliance with Ethical Standards

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: The original study (NCT00508404) and performance of the retrospective analyses described here were supported by Amgen Inc, and medical writing assistance was funded by Amgen (Europe) GmbH.

: Claus-Henning Köhne has received honoraria from Amgen, Bayer, Merck, Pfizer and Servier. Meinolf Karthaus has consulting/advisory roles and has participated in steering committees for Amgen and has received travel/accommodation/expenses from Amgen. Laurent Mineur has consulting/advisory roles for Bayer and Merck, and has received travel/accommodation/expenses from Merck and Ipsen, honoraria from Amgen, Bayer, Ipsen, Merck and Sanofi, and research funding from Chugai, Merck and Sanofi. Josef Thaler has received honoraria and research funding from Amgen. Marc Van den Eynde has consulting/advisory roles for Amgen, Bayer, Merck and Servier, and has received travel/accommodation/expenses from Amgen, Bayer, Merck and Roche, honoraria from Amgen, Bayer, Merck, Roche, Sanofi and Servier, and research funding from Roche. Javier Gallego has consulting/advisory roles for Amgen, Bayer, Celgene, Lilly, Merck Serono, Roche and Sanofi. Reija Koukakis is an Amgen Ltd. employee and owns restricted shares in Amgen. Marloes Berkhout is an Amgen (Europe) GmbH employee and owns restricted shares in Amgen. Ralf-Dieter Hofheinz has received honoraria (lecturer fees) and clinical trial funding from Amgen Ltd. and Merck.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institution and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

: Informed consent was obtained from all individual participants included in the study. No additional consent was required for these retrospective analyses.

: RK and MB were involved in the conception and design of the analyses. RK performed the statistical analyses. C-HK, MK, LM, JT and R-DH collected study data. All authors contributed to the interpretation of the data, the preparation and revision of the manuscript, and approved the final version.

: There is a plan to share data. This may include de-identified individual patient data for variables necessary to address the specific research question in an approved data-sharing request; also related data dictionaries, study protocol, statistical analysis plan, informed consent form and/or clinical study report. Data sharing requests relating to data in this manuscript will be considered after the publication date and (1) this product and indication (or other new use) have been granted marketing authorisation in both the USA and Europe or (2) clinical development discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for these data. Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. A committee of internal advisors reviews requests. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymised individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at .