Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

DABIGATRAN ETEXILATE

Anatomical Therapeutic Chemical (ATC) code

(B01AF01) rivaroxaban
rivaroxaban
(B01AF02) apixaban
apixaban

Medical condition to be studied

Prostate cancer
Population studied

Short description of the study population

The population will be selected from the PCBaSe 4.0 database that contains patients with PCa as well as PCa-free men from the general population in Sweden who have been frequency-matched to incident cases of PCa by birth year and county of residence. A sub-population will include PCa patients with a cancer-related VTE event.
• PCa patients
- Inclusion criteria
Initially all patients newly diagnosed with PCa between 2007-2016 with at least one year before the end of follow up date (31 December 2017) will be included.
From this population, a sub-population of PCa patients with a first cancer-related VTE event will be selected.
- Exclusion criteria
No exclusions will be made.
• Men without PCa
- Inclusion criteria
All PCa-free men included in PCBaSe who are randomly selected from the general population of Sweden with the same birth year and county of residence of PCa patients diagnosed between 2007- 2016.
- Exclusion criteria
A PC free men diagnosed with a prostate cancer during the follow up will be identified and censured.

Age groups

  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Prostate cancer patients

Estimated number of subjects

99999
Study design details

Main study objective

Among all men with PCa: To describe socio-demographic and clinical characteristics at the date of an incident PCa diagnosis. To estimate the occurrence of cancer-related VTE. To describe the cancer therapies in PCa at the initial time after diagnosis. Among men with PCa and a first cancer-related VTE event: To characterize the long-term anticoagulation treatment including choice of drug

Outcomes

Patients' socio-demographic and clinical characteristics at the date of an incident PCa diagnosis Incidence rate of cancer-related VTE Cancer therapies in PCa Choice of anticoagulant drug and duration of treatment Occurrence of recurrent VTE events Time between a first cancer-related and a recurrent VTE event Incidence rate of post-VTE bleeding event, Among PCa-free men: Subject's socio-demographic at the time of inclusion into the database Subject's clinical characteristics at the time of inclusion into the database Incidence rate of VTE events

Data analysis plan

Descriptive statistics will be used to define the socio-demographic and clinical characteristics of all PCa patients and PCa-free men, incidence rate of cancer-related VTE events will be also described by Kaplan-Meier curves in different strata.Anticoagulation treatment received by the PCa patients after the first cancer-related VTE event will be reported by type of anticoagulation (LMWH, VKAs and NOACs) and its estimated duration (up to 3 months, 3-6 months, more than 6 months). Among this sub-group of patients, the occurrence (incidence rates) of recurrent VTE and the time to recurrence, post-VTE bleeding leading to hospitalisation, and mortality will be calculated by the type and duration of AC treatment.