van Bussel, Mark T. J. http://orcid.org/0000-0003-0048-6314
Awada, Ahmad
de Jonge, Maja J. A.
Mau-Sørensen, Morten http://orcid.org/0000-0003-2235-1250
Nielsen, Dorte
Schöffski, Patrick
Verheul, Henk M. W.
Sarholz, Barbara
Berghoff, Karin
El Bawab, Samer
Kuipers, Mirjam
Damstrup, Lars
Diaz-Padilla, Ivan
Schellens, Jan H. M.
Article History
Received: 18 June 2020
Revised: 7 October 2020
Accepted: 22 October 2020
First Online: 24 November 2020
Ethics approval and consent to participate
: The study was conducted in accordance with the ethical principles of the International Council for Harmonisation guideline for Good Clinical Practice and the Declaration of Helsinki, as well as with applicable local regulations. All patients provided written informed consent. The study sites received ethical approval from the following institutional review boards/independent ethical committees: NVK for the region of Hovedstaden, Foundation BEBO, Jules Bordet Institute Ethics Committee, and the Ethics Committee Research UZ/KU Leuven.
: Not applicable.
: Any requests for data by qualified scientific and medical researchers for legitimate research purposes will be subject to the Merck KGaA, Darmstadt, Germany Data Sharing Policy. All requests should be submitted in writing to the Merck KGaA, Darmstadt, Germany data-sharing portal (ExternalRef removed). When Merck KGaA, Darmstadt, Germany has a co-research, co-development, or co-marketing or co-promotion agreement, or when the product has been out-licensed, the responsibility for disclosure might be dependent on the agreement between parties. Under these circumstances, Merck KGaA, Darmstadt, Germany, will endeavour to gain agreement to share data in response to requests.
: M.T.J.v.B., M.M.-S. and D.N. declare no potential conflicts of interest. A.A. has undertaken advisory roles and received speaker fees from Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Eli Lilly, Genomic Health, Hoffmann-La Roche, Ipsen, Leo Pharma, Merck & Co., Novartis and Pfizer. M.J.A.d.J. has participated in advisory boards on behalf of Faron Pharmaceuticals. P.S. has received honoraria and has undertaken consultancy work for Deciphera. H.M.W.V. has participated in advisory boards on behalf of Lava Therapeutics and Glycostem, for which fees were paid to his institution. B.S., K.B., S.E.B. and M.K. are employees of Merck KGaA, Darmstadt, Germany. L.D. was an employee of Merck KGaA, Darmstadt, Germany, at the time of study conduct, and is currently an employee of Debiopharm International S.A., Lausanne, Switzerland. I.D.-P. is an employee of Ares Trading S.A., Eysins, Switzerland; an affiliate of Merck KGaA, Darmstadt, Germany. J.H.M.S. is patent holder on development of oral taxanes and shareholder of Modra Pharmaceuticals B.V.
: Financial support for this study was provided by Merck KGaA, Darmstadt, Germany.