Evidence map›Paper›PMID 38572301›Full record

ArticleEuropean urology open science2024

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.

Pawel Rajwa, Angelika Borkowetz, Thomas Abbott, Andrea Alberti, Anders Bjartell, James T Brash, Riccardo Campi, Andrew Chilelli, Mitchell Conover, Niculae Constantinovici and 34 more

Open access · goldAbstract read
In one paragraph

Article in European urology open science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

44 authors at 20 institutions in 13 countries.

Pawel RajwaDepartment of Urology, Medical University of Silesia, Zabrze, Poland.
Angelika BorkowetzDepartment of Urology, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany.
Thomas AbbottEuropean Association of Urology, Nijmegen, The Netherlands.
Andrea AlbertiUnit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy.
Anders BjartellDepartment of Translational Medicine, Lund University, Lund, Sweden.
James T BrashIQVIA, Real World Solutions, Brighton, UK.
Riccardo CampiUnit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy.
Andrew ChilelliAstellas Pharma Europe Ltd, Surrey, UK.
Mitchell ConoverJanssen Research & Development, Titusville, NJ, USA.
Niculae ConstantinoviciBayer AG, Berlin, Germany.
Eleanor DaviesIQVIA, Real World Solutions, Brighton, UK.
Bertrand De MeulderAssociation EISBM, Vourles, France.
Sherrine EidSAS Institute, Cary, NC, USA.
Mauro GacciUnit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy.
Asieh GolozarOdysseus Data Services, New York, NY, USA.
Haroon HafeezShaukat Khanum Memorial Cancer Hospital & Research Centre, Peshawar, Pakistan.
Samiul HaqueSAS Institute, Cary, NC, USA.
Ayman HijazyAssociation EISBM, Vourles, France.
Tim HulsenDepartment of Hospital Services & Informatics, Philips Research, Eindhoven, The Netherlands.
Andreas JosefssonDepartment of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Sara KhalidUniversity of Oxford, Oxford, UK.
Raivo KoldeInstitute of Computer Science, University of Tartu, Tartu, Estonia.
Daniel KotikCenter for Advanced Systems Understanding, Görlitz, Germany.
Samu KurkiBayer OY, Turku, Finland.
Mark LambrechtSAS Institute, Cary, NC, USA.
Chi-Ho LeungS.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.
Julia MorenoSAS Institute, Cary, NC, USA.
Rossella NicolettiUnit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy.
Daan NieboerErasmus MC University Medical Center, Rotterdam, The Netherlands.
Marek OjaInstitute of Computer Science, University of Tartu, Tartu, Estonia.
Soundarya PalanisamySAS Institute, Cary, NC, USA.
Peter PrinsenNetherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.
Christian ReichOdysseus Data Services, New York, NY, USA.
Giulio Raffaele RestaUnit of Urological Robotic Surgery and Renal Transplantation, University of Florence, Careggi Hospital, Florence, Italy.
Maria J RibalUro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain.
Juan Gómez RivasDepartment of Urology, Hospital Clinico San Carlos, Madrid, Spain.
Emma SmithGuidelines Office, European Association of Urology, Arnhem, The Netherlands.
Robert SnijderJanssen Research & Development, Titusville, NJ, USA.
Carl SteinbeisserCollaborate Project Management, Munich, Germany.
Frederik VandenbergheSAS Institute, Cary, NC, USA.
Philip CornfordLiverpool University Hospitals NHS Trust, Liverpool, UK.
Susan Evans-AxelssonBayer AG, Berlin, Germany.
James N'DowAcademic Urology Unit, University of Aberdeen, Aberdeen, UK.
Peter-Paul M WillemseDepartment of Urology, Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands.
SAS Institute (United States) · USUniversity of Florence · ITBayer (Germany) · DEEuropean Association of Urology · NLEuropean Institute for Systems Biology and MedicineIQVIA (United Kingdom) · GBJanssen (United States) · USNortheastern University · USUniversity Medical Center Utrecht · NLUniversity of Aberdeen · GBUniversity of Tartu · EEAstellas Pharma (United Kingdom) · GBBayer (Finland) · FIChinese University of Hong Kong · HKErasmus MC · NLHelmholtz-Zentrum Dresden-Rossendorf · DEHospital Clínico San Carlos · ESLund University · SEMedical University of Silesia · PLPhilips (Netherlands) · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Androgen receptor signaling inhibitorBig dataDocetaxelHormone sensitiveMetastaticPIONEERProstate cancer

Identifiers

PMID38572301
PMCPMC10987796
OpenAlexW4393176999

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.