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Port EU Post B0661017 Final Report PASS information Title Post-approval safety study (PASS) of the utili- zation pattern of apixaban in Sweden Version identifier of the final study report 1.0 Date of last version of the final study re- 20 May 2016 port EU Post Authorisation Study (PAS) regis- ENCEPP/SDPP/5184 ter number Active substance B01AF02, Apixaban Medicinal product Eliquis Product reference EU/1/11/691/001-015 Procedure number EMEA/H/C/002148 Marketing Authorisation Holder (MAH) Bristol-Myers Squibb/Pfizer EEIG, Joint PASS No Research question and objectives The objectives of the study are to: 1. Estimate the proportions of apixaban users in the out-patient setting who receive the drug for the approved indications at the time of the study, 2. Describe the characteristics of the patients -2016 15:21 y who are prescribed apixaban in the out-patient setting for on-label and off-label indications. Country(-ies) of study Sweden Authors roved On: 23-Ma pp roved\A pp 090177e188105745\A PASS of the utilization pattern of apixaban in Sweden 1 Centre for Pharmacoepidemiology, Karolinska Institutet Final Study Report version 20 May 2016 Page 1/32 Approved v 1.0 930102383 1.0 B0661017 Final Report Marketing Authorisation Holder(s) Marketing Authorisation Holder(s) Bristol-Myers Squibb/Pfizer EEIG, Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH United Kingdom MAH contact person -2016 15:21 y roved On: 23-Ma pp roved\A pp 090177e188105745\A PASS of the utilization pattern of apixaban in Sweden 2 Centre for Pharmacoepidemiology, Karolinska Institutet Final Study Report version 20 May 2016 Page 2/32 Approved v 1.0 930102383 1.0 B0661017 Final Report TABLE OF CONTENTS LIST OF TABLES.....................................................................................................................4 LIST OF FIGURES ...................................................................................................................4 1. ABSTRACT...........................................................................................................................5 2. LIST OF ABBREVIATIONS................................................................................................8 3. INVESTIGATORS................................................................................................................9 4. OTHER RESPONSIBLE PARTIES......................................................................................9 5. MILESTONES.......................................................................................................................9 6. RATIONALE AND BACKGROUND................................................................................10 7. RESEARCH QUESTION AND OBJECTIVES .................................................................11 8. AMENDMENTS AND UPDATES.....................................................................................11 9. RESEARCH METHODS ....................................................................................................12 9.1. Study design ............................................................................................................12 9.2. Setting......................................................................................................................12 9.3. Subjects ...................................................................................................................12 9.4. Variables..................................................................................................................13 9.4.1. Endpoints.......................................................................................................13 -2016 15:21 y 9.4.2. Definition of THA/TKA................................................................................14 9.4.3. Definition of NVAF ......................................................................................14 9.4.4. Identification of DVT/PE ..............................................................................14 9.4.5. Decision Rules for On- and Off-Label Classification...................................14 9.5. Data sources and measurement ...............................................................................17 roved On: 23-Ma 9.6. Bias..........................................................................................................................17 pp 9.7. Study Size................................................................................................................18 9.8. Data transformation.................................................................................................18 roved\A pp 9.9. Statistical methods...................................................................................................18 9.9.1. Main summary measures...............................................................................18 9.9.2. Main statistical methods................................................................................19 9.9.3. Missing values...............................................................................................19 9.9.4. Sensitivity analyses .......................................................................................19 9.9.5. Amendments to the statistical analysis plan..................................................19 090177e188105745\A 9.10. Quality control.......................................................................................................19 PASS of the utilization pattern of apixaban in Sweden 3 Centre for Pharmacoepidemiology, Karolinska Institutet Final Study Report version 20 May 2016 Page 3/32 Approved v 1.0 930102383 1.0 B0661017 Final Report 10. RESULTS ..........................................................................................................................19 10.1. Participants............................................................................................................19 10.2. Descriptive data.....................................................................................................20 10.3. Outcome data.........................................................................................................21 10.4. Main results ...........................................................................................................21 10.5. Other analyses .......................................................................................................25 10.6. Adverse events / adverse reactions........................................................................25 11. DISCUSSION....................................................................................................................26 11.1. Key results.............................................................................................................26 11.2. Limitations ............................................................................................................27 11.3. Interpretation .........................................................................................................28 11.4. Generalisability .....................................................................................................29 12. OTHER INFORMATION .................................................................................................29 13. CONCLUSION..................................................................................................................29 14. REFERENCES ..................................................................................................................29 APPENDICES .........................................................................................................................31 Appendix 1: Core tables, figures and data summaries ...................................................31 -2016 15:21 Appendix 2: Data derivation details...............................................................................31 y Appendix 3: Data source details.....................................................................................31 ANNEX 1: LIST OF STAND-ALONE DOCUMENTS.........................................................32 ANNEX 2: ADDITIONAL INFORMATION.........................................................................32 roved On: 23-Ma LIST OF TABLES pp Table 1. Indications for apixaban and dates of authorization ..................................................10 Table 2: Other specified off-label diagnoses ...........................................................................17 roved\A Table 3. General characteristics of apixaban-treated patients (hospital data)..........................21 pp Table 4. On-label and off-label apixaban utilization by year and indication...........................22 Table 5 Treatment dose and duration among apixaban-treated patients, by on-label, off- label or unclassified indications................................................................................25 LIST OF FIGURES Figure 1. Decision process for identifying on- vs. off-label use ..............................................16 090177e188105745\A Figure 2. Participants in the study............................................................................................20 PASS of the utilization pattern of apixaban in Sweden 4 Centre for Pharmacoepidemiology, Karolinska Institutet Final Study Report version 20 May 2016 Page 4/32 Approved v 1.0 930102383 1.0 B0661017 Final Report 1. ABSTRACT Title POST-APPROVAL SAFETY STUDY
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