Funding for this research was provided by:
Janssen Pharmaceutica NV (n/a)
Text and Data Mining valid from 2019-01-14
Received: 30 August 2018
Accepted: 7 January 2019
First Online: 14 January 2019
Ethics approval and consent to participate
: Where applicable, the study protocol was reviewed by an Independent Ethics Committee (IEC) or Institutional Review Board (IRB). In addition, the study was presented or notified to regional and site IEC/IRBs if required by local laws or regulations or hospital policies. Specifically: i) in Belgium, each of the IECs from all the participating sites approved the study (ie, Comité d’Ethique - Erasme Université Libre de Bruxelles [ULB], Comité d’Ethique Centre Hospitalier de Wallonie Picarde [CHWAPI], Comité d’Ethique Centre Hospitalier Peltzer-La Tourelle, Commissie voor Medische Ethiek St. Jozefkliniek Izegem, Commissie voor Medisch Ethiek Algemeen Ziekenhuis [AZ] Groeninge Kortrijk, Commissie voor Medisch Ethiek AZ Klina, Ethisch Comité AZ Nikolaas, Comité d’Ethique Médical Clinique Saint Joseph Liège, Commissie voor Ethiek AZ St. Jan Brugge Oostende); ii) in France, national approvals were granted by the “Comité consultatif sur le traitement de l’information en matière de recherche” (CCTIRS), the “Conseil National de l’Ordre des Médecins” (CNOM) and the “Commission nationale de l’informatique et des libertés” (CNIL); iii) in Germany, the IEC committee granting approval was the “Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität” (reference number: 2015–526-f-S), belonging to the Medical Council Westfalen-Lippe; and iv) in the UK the research ethics committee (REC) providing approval was the “London – South East REC” (reference number: 16/LO/0232). Patients who were still living also had to give written informed consent in accordance with local requirements; deceased patients who met the eligibility criteria were enrolled automatically.
: Not applicable
: MB has been a speaker and/or has had an advisory role for Janssen, Astellas, Bayer, Abx, Ipsen, Exelixis, BMS, MSD, Pfizer, Eisai, Sanofi, Novartis and Amgen; AB has participated in advisory boards from Janssen, Astellas, Bayer, Sanofi, Aventis and Roche; has received educational support for meetings from Bayer, Janssen, Sanofi and Novartis; and has received speaker fees from Pfizer, Sanofi and Roche. WH has participated on advisory boards for Janssen and Sanofi; GB has participated in advisory and working boards for Sanofi and Janssen. LD has participated on boards for Janssen and Novartis, and has been a speaker for Astellas. LGA works for IQVIA as a consultant for Janssen in this project; LA and GP are Janssen employees and hold stock in Johnson & Johnson; PR is a Janssen employee; ML is employed by PAREXEL as a Study Responsible Physician for Janssen in this project; and TE has received from Janssen payments for conference attendance, travel and accommodation.SK, CD, EE, MH, DH, and GM do not have competing interests to declare.
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