Muñoz Martín, Andrés J. https://orcid.org/0000-0001-6977-8249
Lecumberri, Ramón https://orcid.org/0000-0002-8850-8866
Souto, Juan Carlos https://orcid.org/0000-0003-2092-5142
Obispo, Berta https://orcid.org/0000-0003-1214-6595
Sanchez, Antonio https://orcid.org/0000-0001-6273-5078
Aparicio, Jorge https://orcid.org/0000-0001-5527-0786
Aguayo, Cristina https://orcid.org/0000-0002-4335-0313
Gutierrez, David https://orcid.org/0000-0001-9593-4559
García Palomo, Andrés https://orcid.org/0000-0002-9159-9025
Benavent, Diego https://orcid.org/0000-0001-9119-5330
Taberna, Miren https://orcid.org/0000-0002-2446-186X
Viñuela-Benéitez, María Carmen https://orcid.org/0000-0001-6984-0727
Arumi, Daniel https://orcid.org/0000-0002-6638-7485
Hernández-Presa, Miguel Ángel https://orcid.org/0009-0002-1657-1118
Funding for this research was provided by:
BMS-Pfizer Alliance
Article History
Received: 24 April 2024
Accepted: 24 June 2024
First Online: 14 September 2024
Change Date: 21 November 2024
Change Type: Update
Change Details: The original online version of this article was revised to correct the affiliation for author María Carmen Viñuela Benéitez.
Change Date: 19 November 2024
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s12094-024-03780-2
Declarations
:
: DB and MT are employees of Savana, which was a paid consultant to BMS-Pfizer Alliance. DA and MAHP are employees of Pfizer Company, one of the study sponsors.
: AM declares personal fees and non-financial support from Celgene, Sanofi, Pfizer-Bristol Myers Squibb (BMS), LEO Pharma, Daiichi Sankyo, Incyte, AstraZeneca, MSD Oncology, Lilly, Roche, Rovi, Bayer, Servier Menarini, Merk Serono and Amgen. RL declares personal fees from Rovi, LEO Pharma, Sanofi and Janssen. JS declares personal fees and non-financial support from Rovi, Stago Laboratories, Pfizer, LEO Pharma and Devicare. BO declares personal fees from Sanofi, Lilly, Angellini, LEO Pharma and Rovi. JA has received personal fees from Servier, Merk, Bayer, Amgen, Sirtex Medical, Sanofi, Roche and Celgene. CA declares non-financial support from GlaxoSmithKline, Pfizer, MSD Oncology, Novartis and Pierre Fabre. AG declares personal fees from Roche, Amgen, MSD Oncology, Eisai Europe, Novartis and Pierre Fabre. AM, RL, JS, BO, AS, JA, CA, DG, AG, MV declare honorarium from BMS-Pfizer Alliance in connection with the development of this manuscript. The remaining authors declare no competing interests.
: The study was classified as a non-postauthorization study by the Spanish Agency of Medicines and Health Products and was approved by the corresponding Institutional Review Boards of the participating centers. Patient consent was waived because aggregated and anonymized data were analyzed from deidentified EHRs.
: This study was approved by the Ethics Committee of Research with Medicines (CEIm) of Fundación Jiménez Díaz (CEIm: #EO094-19_FJD) and the institutional Review Board of each participating hospital after being classified as a ‘other post-authorization study (EPA-OD)’ by the Spanish Agency of Medicines and Health Products (AEMPS). All methods and analysis followed legal and regulatory requirements and followed generally accepted research practices described in the Helsinki Declaration in its latest edition. All data were collected from patients’ EHRs, which were anonymized and aggregated in an irreversible, dissociated manner. Patient consent was therefore not required. Results are reported following the Transparent Reporting of a multivariate prediction model for Individual Prognosis or Diagnosis (TRIPOD) guidelines.