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Characterising the Risk of Major Bleeding in Patients With EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods ..................................................................................................................... 9 Descriptive study investigating the utilization of DOACs in NVAF patients (objective 2) ............. 10 9.1a Study design ................................................................................................................................. 10 9.2a Setting ......................................................................................................................................... 10 9.3a Variables ...................................................................................................................................... 10 Descriptive study investigating prescriber compliance with SmPC recommendations (objective 3) ................................................................................................................................................... 13 9.1b Study design ................................................................................................................................ 13 9.2b Setting ......................................................................................................................................... 13 9.3b Variables ...................................................................................................................................... 13 Cohort study (objective 1) .......................................................................................................... 16 9.1c Study design ................................................................................................................................. 16 9.2c Setting .......................................................................................................................................... 16 9.3c Variables ...................................................................................................................................... 16 Outcome ............................................................................................................................................................... 16 Exposure definition ............................................................................................................................................... 16 Assessment of the length of individual (D)OAC prescriptions .............................................................................. 17 Treatment episodes .............................................................................................................................................. 17 Exposure characteristics ....................................................................................................................................... 18 Potential confounders .......................................................................................................................................... 18 Effect modifiers (subgroups) ................................................................................................................................ 18 9.4 Data sources .................................................................................................................................. 19 9.4.1 Database characteristics ................................................................................................................. 19 Mondriaan ............................................................................................................................................................ 21 Danish National Registries .................................................................................................................................... 21 Bavarian claims database ..................................................................................................................................... 21 AOK NORDWEST ................................................................................................................................................... 21 BIFAP ..................................................................................................................................................................... 22 System for the Development of Research in Primary Care (SIDIAP) .................................................................... 22 Clinical Practice Research Datalink (CPRD UK) ...................................................................................................... 22 French Claims database: EGB ............................................................................................................................... 23 9.4.2 Period of valid data collection ......................................................................................................... 23 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 2 CPRD/Mondriaan/BIFAP/SIDIAP ........................................................................................................................... 23 Danish National Registries .................................................................................................................................... 23 Bavarian claims database ..................................................................................................................................... 23 AOK NORDWEST ................................................................................................................................................... 23 EGB........................................................................................................................................................................ 23 9.5 Study size ....................................................................................................................................... 24 9.6 Data management ......................................................................................................................... 26 9.6.1 Data storage .................................................................................................................................... 26 9.6.2 Data access and sharing .................................................................................................................. 26 9.7 Data analysis .................................................................................................................................. 26 9.7a Descriptive study investigating the utilization of DOACs in NVAF patients (Objective 2) ............... 26 9.7b Descriptive study investigating prescriber compliance with SmPC recommendations (Objective 3) .................................................................................................................................................................. 27 9.7c Cohort study (Objective 1) ................................................................................................................ 28 9.8 Quality control ............................................................................................................................... 28 9.8.1 Quality control ................................................................................................................................. 28 9.8.2 Quality management system of coordinator of consortium (Universiteit Utrecht) ....................... 28 9.9 Limitations of the research methods .............................................................................................. 29 9.9.1 Limitations related to the data source ............................................................................................ 29 9.9.2 Limitations related to methodology ............................................................................................... 29 9.9.3 Methodological study on exposure misclassification ..................................................................... 29 Study 1. Primary non-adherence .........................................................................................................................
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