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Research protocol f...
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
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- Rajwa, Pawel (författare)
- Department of Urology, Medical University of Silesia, Zabrze, Poland; Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
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- Borkowetz, Angelika (författare)
- Department of Urology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany,University Clinic Carl Gustav Carus at the TU Dresden
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- 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
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- Bjartell, Anders (författare)
- Lund University,Lunds universitet,Avdelningen för translationell cancerforskning,Institutionen för laboratoriemedicin,Medicinska fakulteten,Urologisk cancerforskning, Malmö,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Division of Translational Cancer Research,Department of Laboratory Medicine,Faculty of Medicine,Urological cancer, Malmö,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments
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- Brash, James T. (författare)
- IQVIA, Real World Solutions, Brighton, United Kingdom,IQVIA Inc.
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- Campi, Riccardo (författare)
- Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
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- Chilelli, Andrew (författare)
- Astellas Pharma Europe Ltd, Surrey, United Kingdom
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- Conover, Mitchell (författare)
- Janssen Research & Development, NJ, Titusville, United States,Janssen Research & Development, Belgium
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- Constantinovici, Niculae (författare)
- Bayer AG, Berlin, Germany,Bayer Pharma AG
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- Davies, Eleanor (författare)
- IQVIA, Real World Solutions, Brighton, United Kingdom,IQVIA Inc.
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- De Meulder, Bertrand (författare)
- Association EISBM, Vourles, France
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- Eid, Sherrine (författare)
- SAS Institute, NC, Cary, United States
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- Gacci, Mauro (författare)
- Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
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- Golozar, Asieh (författare)
- Odysseus Data Services, NY, New York, United States; OHDSI Center, Northeastern University, MA, Boston, United States
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- Hafeez, Haroon (författare)
- Shaukat Khanum Memorial Cancer Hospital & Research Centre, Peshawar, Pakistan
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- Haque, Samiul (författare)
- SAS Institute, NC, Cary, United States
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- Hijazy, Ayman (författare)
- Association EISBM, Vourles, France
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- Hulsen, Tim (författare)
- Department of Hospital Services & Informatics, Philips Research, Eindhoven, Netherlands
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- Josefsson, Andreas, 1979- (författare)
- Umeå University,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
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- Khalid, Sara (författare)
- University of Oxford, Oxford, United Kingdom
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- Kolde, Raivo (författare)
- Institute of Computer Science, University of Tartu, Estonia, Tartu, Estonia
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- Kotik, Daniel (författare)
- Center for Advanced Systems Understanding, Görlitz, Germany; Helmholtz-Zentrum Dresden-Rossendorf, Dresden, Germany
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- Kurki, Samu (författare)
- Bayer OY, Turku, Finland
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- Lambrecht, Mark (författare)
- SAS Institute, NC, Cary, United States
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- Leung, Chi-Ho (författare)
- S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong
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- Moreno, Julia (författare)
- SAS Institute, NC, Cary, United States
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- Nicoletti, Rossella (författare)
- Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
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- Nieboer, Daan (författare)
- Erasmus MC University Medical Center, Rotterdam, Netherlands
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- Oja, Marek (författare)
- Institute of Computer Science, University of Tartu, Estonia, Tartu, Estonia
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- Palanisamy, Soundarya (författare)
- SAS Institute, NC, Cary, United States
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- Prinsen, Peter (författare)
- Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, Netherlands
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- Reich, Christian (författare)
- Odysseus Data Services, NY, New York, United States; OHDSI Center, Northeastern University, MA, Boston, United States
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- Raffaele Resta, Giulio (författare)
- Unit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy
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- Ribal, Maria J. (författare)
- Uro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain
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- Gómez Rivas, Juan (författare)
- Department of Urology, Hospital Clinico San Carlos, Madrid, Spain
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- Smith, Emma (författare)
- Guidelines Office, European Association of Urology, Arnhem, Netherlands
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- Snijder, Robert (författare)
- Janssen Research & Development, NJ, Titusville, United States,Janssen Research & Development, Belgium
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- Steinbeisser, Carl (författare)
- Collaborate Project Management, Munich, Germany
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- Vandenberghe, Frederik (författare)
- SAS Institute, NC, Cary, United States
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- Cornford, Philip (författare)
- Liverpool University Hospitals NHS Trust, Liverpool, United Kingdom,University of Liverpool
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- Evans-Axelsson, Susan (författare)
- Bayer AG, Berlin, Germany,Bayer Pharma AG
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- N'Dow, James (författare)
- Academic Urology Unit, University of Aberdeen, Aberdeen, United Kingdom
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- 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.
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Ingår i: European Urology Open Science. - : Elsevier. - 2666-1691 .- 2666-1683. ; 63, s. 81-88
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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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
- Androgen receptor signaling inhibitor
- Big data
- Docetaxel
- Hormone sensitive
- Metastatic
- PIONEER
- Prostate cancer
Publikations- och innehållstyp
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Till lärosätets databas
- Av författaren/redakt...
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Rajwa, Pawel
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Borkowetz, Angel ...
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Abbott, Thomas
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Alberti, Andrea
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Bjartell, Anders
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Brash, James T.
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visa fler...
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Campi, Riccardo
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Chilelli, Andrew
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Conover, Mitchel ...
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Constantinovici, ...
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Davies, Eleanor
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De Meulder, Bert ...
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Eid, Sherrine
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Gacci, Mauro
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Golozar, Asieh
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Hafeez, Haroon
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Haque, Samiul
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Hijazy, Ayman
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Hulsen, Tim
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Josefsson, Andre ...
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Khalid, Sara
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Kolde, Raivo
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Kotik, Daniel
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Kurki, Samu
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Lambrecht, Mark
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Leung, Chi-Ho
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Moreno, Julia
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Nicoletti, Rosse ...
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Nieboer, Daan
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Oja, Marek
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Palanisamy, Soun ...
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Prinsen, Peter
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Reich, Christian
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Raffaele Resta, ...
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Ribal, Maria J.
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Gómez Rivas, Jua ...
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Smith, Emma
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Snijder, Robert
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Steinbeisser, Ca ...
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Vandenberghe, Fr ...
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Cornford, Philip
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Evans-Axelsson, ...
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N'Dow, James
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Willemse, Peter- ...
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Urologi och njur ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
- Artiklar i publikationen
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European Urology ...
- Av lärosätet
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Umeå universitet
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Lunds universitet