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Research protocol for an observational health data analysis on the adverse events of systemic treatment in patients with metastatic hormone-sensitive prostate cancer : big data analytics using the PIONEER platform

Rajwa, Pawel (författare)
Department of Urology, Medical University of Silesia, Zabrze, Poland; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
Borkowetz, Angelika (författare)
Department of Urology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany
Abbott, Thomas (författare)
European Association of Urology, Nijmegen, Netherlands
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Alberti, Andrea (författare)
Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
Bjartell, Anders (författare)
Department of Translational Medicine, Lund University, Lund, Sweden
Brash, James T. (författare)
IQVIA, Real World Solutions, Brighton, United Kingdom
Campi, Riccardo (författare)
Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
Chilelli, Andrew (författare)
Astellas Pharma Europe Ltd, Surrey, United Kingdom
Conover, Mitchell (författare)
Janssen Research & Development, NJ, Titusville, United States
Constantinovici, Niculae (författare)
Bayer AG, Berlin, Germany
Davies, Eleanor (författare)
IQVIA, Real World Solutions, Brighton, United Kingdom
De Meulder, Bertrand (författare)
Association EISBM, Vourles, France
Eid, Sherrine (författare)
SAS Institute, NC, Cary, United States
Gacci, Mauro (författare)
Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
Golozar, Asieh (författare)
Odysseus Data Services, NY, New York, United States; OHDSI Center, Northeastern University, MA, Boston, United States
Hafeez, Haroon (författare)
Shaukat Khanum Memorial Cancer Hospital & Research Centre, Peshawar, Pakistan
Haque, Samiul (författare)
SAS Institute, NC, Cary, United States
Hijazy, Ayman (författare)
Association EISBM, Vourles, France
Hulsen, Tim (författare)
Department of Hospital Services & Informatics, Philips Research, Eindhoven, Netherlands
Josefsson, Andreas, 1979- (författare)
Umeå universitet,Wallenberg centrum för molekylär medicin vid Umeå universitet (WCMM),Institutionen för diagnostik och intervention,Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Khalid, Sara (författare)
University of Oxford, Oxford, United Kingdom
Kolde, Raivo (författare)
Institute of Computer Science, University of Tartu, Estonia, Tartu, Estonia
Kotik, Daniel (författare)
Center for Advanced Systems Understanding, Görlitz, Germany; Helmholtz-Zentrum Dresden-Rossendorf, Dresden, Germany
Kurki, Samu (författare)
Bayer OY, Turku, Finland
Lambrecht, Mark (författare)
SAS Institute, NC, Cary, United States
Leung, Chi-Ho (författare)
S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong
Moreno, Julia (författare)
SAS Institute, NC, Cary, United States
Nicoletti, Rossella (författare)
Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
Nieboer, Daan (författare)
Erasmus MC University Medical Center, Rotterdam, Netherlands
Oja, Marek (författare)
Institute of Computer Science, University of Tartu, Estonia, Tartu, Estonia
Palanisamy, Soundarya (författare)
SAS Institute, NC, Cary, United States
Prinsen, Peter (författare)
Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, Netherlands
Reich, Christian (författare)
Odysseus Data Services, NY, New York, United States; OHDSI Center, Northeastern University, MA, Boston, United States
Raffaele Resta, Giulio (författare)
Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
Ribal, Maria J. (författare)
Uro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain
Gómez Rivas, Juan (författare)
Department of Urology, Hospital Clinico San Carlos, Madrid, Spain
Smith, Emma (författare)
Guidelines Office, European Association of Urology, Arnhem, Netherlands
Snijder, Robert (författare)
Janssen Research & Development, NJ, Titusville, United States
Steinbeisser, Carl (författare)
Collaborate Project Management, Munich, Germany
Vandenberghe, Frederik (författare)
SAS Institute, NC, Cary, United States
Cornford, Philip (författare)
Liverpool University Hospitals NHS Trust, Liverpool, United Kingdom
Evans-Axelsson, Susan (författare)
Bayer AG, Berlin, Germany
N'Dow, James (författare)
Academic Urology Unit, University of Aberdeen, Aberdeen, United Kingdom
Willemse, Peter-Paul M. (författare)
Department of Urology, Cancer Center, University Medical Center Utrecht, Utrecht, Netherlands
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 (creator_code:org_t)
Elsevier, 2024
2024
Engelska.
Ingår i: European Urology Open Science. - : Elsevier. - 2666-1691 .- 2666-1683. ; 63, s. 81-88
Relaterad länk:
https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Combination therapies in metastatic hormone-sensitive prostate cancer (mHSPC), which include the addition of an androgen receptor signaling inhibitor and/or docetaxel to androgen deprivation therapy, have been a game changer in the management of this disease stage. However, these therapies come with their fair share of toxicities and side effects. The goal of this observational study is to report drug-related adverse events (AEs), which are correlated with systemic combination therapies for mHSPC. Determining the optimal treatment option requires large cohorts to estimate the tolerability and AEs of these combination therapies in “real-life” patients with mHSPC, as provided in this study. We use a network of databases that includes population-based registries, electronic health records, and insurance claims, containing the overall target population and subgroups of patients defined by unique certain characteristics, demographics, and comorbidities, to compute the incidence of common AEs associated with systemic therapies in the setting of mHSPC. These data sources are standardised using the Observational Medical Outcomes Partnership Common Data Model. We perform the descriptive statistics as well as calculate the AE incidence rate separately for each treatment group, stratified by age groups and index year. The time until the first event is estimated using the Kaplan-Meier method within each age group. In the case of episodic events, the anticipated mean cumulative counts of events are calculated. Our study will allow clinicians to tailor optimal therapies for mHSPC patients, and they will serve as a basis for comparative method studies.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

Nyckelord

Androgen receptor signaling inhibitor
Big data
Docetaxel
Hormone sensitive
Metastatic
PIONEER
Prostate cancer

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