Schneeweiss, Andreas
Park-Simon, Tjoung-Won
Albanell, Joan
Lassen, Ulrik
Cortés, Javier
Dieras, Veronique
May, Marcus
Schindler, Christoph
Marmé, Frederik
Cejalvo, Juan Miguel
Martinez-Garcia, Maria
Gonzalez, Iria
Lopez-Martin, Jose
Welt, Anja
Levy, Christelle
Joly, Florence
Michielin, Francesca
Jacob, Wolfgang http://orcid.org/0000-0002-8171-7542
Adessi, Céline
Moisan, Annie
Meneses-Lorente, Georgina
Racek, Tomas
James, Ian
Ceppi, Maurizio
Hasmann, Max
Weisser, Martin
Cervantes, Andrés
Article History
Received: 21 December 2017
Accepted: 10 January 2018
First Online: 19 January 2018
Compliance with ethical standards
:
: Andreas Schneeweiss, Tjoung-Won Park-Simon, Ulrik Lassen, Marcus May, Christoph Schindler, Frederik Marmé, Juan Miguel Cejalvo, Maria Martinez-Garcia, Iria Gonzalez, Christelle Levy, Florence Joly, Andrés Cervantes declare no conflict of interest, Joan Albanell, Roche advisory board participation; Javier Cortés, Remuneration from Roche, Eisai, Novartis, Celgene, Pfizer; consultant or advisory board participation for Roche, Celgene, AztraZeneca and Cellestia, Biothera, Merus; Veronique Dieras, Remuneration from Roche, Pfizer, Novartis, Lilly, AstraZeneca; consultant or advisory board for Mylan, Puma; Jose Lopez-Martin, Consultant or advisory board for Roche, AstraZeneca, Celgene, Pfizer, BMS, MSD, Novartis, Pierre Fabre; stock ownership of PharmaMar; Anja Welt, Remuneration from Roche, Novartis, Pfizer, AstraZeneca, Interplan; Consultant or advisory board from Pfizer, Roche, Novartis, Tesaro; Funding from Novartis; Francesca Michielin, Celine Adessi, Sponsor employees; Wolfgang Jacob, Annie Moisan, Georgina Meneses-Lorente, Tomas Racek, Maurizio Ceppi, Max Hasmann, Martin Weisser, Sponsor employees and sponsor stock ownership; Ian James, Sponsor consultant from A4P.
: Local ethics committee approval was obtained and all patients provided written informed consent. The study was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki in nine centers in Denmark, France, Germany and Spain. The following ethics committees approved the study: Denmark (Videnskabsetiske Komiteer Region Hovedstaden on 24 Apr 2013), Spain (Hospital Clinico Universitario de Valencia CEIC on 07 May 2013; CEIC Hospital Universitario 12 de Octubre on 07 May 2013; CEIC Parc de Salut Mar; IMIM- Hospital del Mar, C/ Dr. Aiguader, 88, Planta 1, 08003, Barcelona on 07 May 2013; CEIC Hospital Vall D’Hebron on 15 Oct 2014), Germany (Ethikkommission der Medizinischen Fakultät Heidelberg on 21 Aug 2013 and on 23 Feb 2015) and France (Comite de protection des personnes Ile de France III on 17 Jun 2013 and on 30 Jun 2013).
: Francesca Michielin, Wolfgang Jacob, Celine Adessi, Annie Moisan, Georgina Meneses-Lorente, Tomas Racek, Maurizio Ceppi, Max Hasmann and Martin Weisser are employees of F. Hoffmann-La Roche. Wolfgang Jacob, Annie Moisan, Georgina Meneses-Lorente, Tomas Racek, Maurizio Ceppi, Max Hasmann and Martin Weisser own stocks of F. Hoffmann-La Roche. Ian James works as a consultant for F. Hoffmann-La Roche. Javier Cortés, Veronique Dieras and Anja Welt received remuneration from F. Hoffmann-La Roche. Javier Cortés, Anja Welt and Jose Lopez-Martin worked as a consultant or as member of an advisory board for F. Hoffmann-La Roche.