Chekerov, Radoslav
Arndt, Tjadina
Pietzner, Klaus
Canzler, Ulrich
Wimberger, Pauline
Strauß, Hans-Georg
Mahner, Sven
Woelber, Linn
de Gregorio, Nikolaus
Stocker, Gertraud
von Abel, Ekkehard
Neunhoeffer, Tanja
Belau, Antje Kristina
Mustea, Alexander
Yalinkaya, Isil
Braicu, Elena Ioana
Richter, Rolf
Sehouli, Jalid
,
Funding for this research was provided by:
Charité - Universitätsmedizin Berlin
Article History
Received: 23 December 2022
Accepted: 9 February 2023
First Online: 31 March 2023
Declarations
:
: We declare the following potential <i>conflicts of interest</i>. Employment: none of the authors. Stock or other Ownership: none of the authors. Honoraria: Roche, Eisai, Novartis, MSD, Seagen, GSK, Astra Zeneca, Pfizer, Lumenis, TEVA, pomedicis, Omniamed, PharmaMar, Vifor Pharma, Hexal AG, Lilly (RC, KP, UC, PW, SM, LW, NdG, GS, EvA, AM, EIB, JS). Consulting or advisory role: AstraZeneca, Roche, GSK, Clovis, Eisai, MSD, Seagen, Tesaro, Merck, Novocure, Olympus, Sensor Kinesis, Nykode, Myriad, Daichy (KP, PW, UC, SM, LW, NdG, AM, TN, EIB, JS). Research funding: Roche, GSK, AstraZeneca, Amgen, Novartis, Lilly, Bayer, Medac, Clovis, PharmaMar, Tesaro, Novocure (RC, KP, PW, SM, LW, NdG, GS, AKB, AM, TN, EIB, JS). Patents, Rolayties or Intellectual property: none of the authors. Expert Testimony: none of the authors. Travel, Accomodation, Expenses: Medac, Roche, GSK, AstraZeneca, Lilly (RC, KP, PW, SM, LW, NdG, AM, EIB, JS). Other relationship: none of the authors.
: The study was conducted according to the Declaration of Helsinki (1996), the International Conference on Harmonization Good Clinical Practice recommendations, and provisions of the German Medicines Act. The Ethical review committee—Ethikkommission des Landes Berlin, reference number 11/0570 ZS EK, approved the study protocol; final study approval by the German federal authority—Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), reference number 61–3910-4037860, was granted on 04.04.2012. All amendments and other relevant study documentation were voted by the ethics committee and approved by the German federal authority BfArM: amendment 1 approved on 31.10.2012, amendment 2 approved on 27.05.2013, amendment 3 approved on 26.03.2014, amendment 4 approved on 09.03.2015 and amendment 5 approved on 13.04.2016.
: All patients provided written informed consent before study start.