Status: Finalised First registered on: 23/09/2016
Last updated on: 06/12/2018
1. Study identification
EU PAS Register NumberEUPAS15491
Official titleIncidence of Second primary MAlignancies in pRostate Cancer patients with bOne metastases – an observational retrospective cohort study in Sweden (SMARCOS)
Study title acronym
Study typeObservational study
Brief description of the studyAn observational retrospective cohort study in Sweden to investigate incidence of second primary malignancies in prostate cancer patients with bone metastases
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEPID Research
Department/Research group
Organisation/affiliationEPID Research Oy
Website/Homepagewww.epidresearch.com
Details of (Primary) lead investigator
Title Dr
Last name Bayer AG
First name Bayer Clinical Trials Contact
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/11/201520/11/2015
Start date of data collection15/11/201615/11/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report06/10/201706/10/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer HealthCare Pharmaceutical Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bayer AG
First name Bayer Clinical Trials Contact
Address line 1Muellerstrasse 178
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials Contact 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com 
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