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Non-Interventional (Ni) Study Protocol Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Update 1, 08 January 2016 NON-INTERVENTIONAL (NI) STUDY PROTOCOL Post Author isation Safet y St udi es (PA SS) infor mation Title CARBOS – Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims database study in Germany Protocol number B0661069 Protocol version identifier Update 1.0 Date of last version of protocol 08 January 2016 EU Post Authorisation Study (PAS) ENCEPP/SDPP/11313 register number Active substance Apixaban (B01AF02) Phenprocoumon (B01AA04) Rivaroxaban (B01AX06; B01AF01) Dabigatran (B01AX06) Product reference EU/1/11/691/006 EU/1/11/691/007 EU/1/11/691/008 EU/1/11/691/009 EU/1/11/691/010 EU/1/11/691/011 Pfizer Confidential Page 1 of 112 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Update 1, 08 January 2016 EU/1/11/691/012 EU/1/11/691/014 Procedure number Not Available Marketing Authorisation Holder (MAH) Pfizer Pharma GmbH Joint PASS No Research question and objectives The aim of this study is to investigate whether there are differences in the occurrence of major bleeding events in patients with NVAF and prescribed oral anticoagulation therapies in a real-world setting. It will be investigated whether the occurrence of major bleeding events in NVAF patients under anticoagulant therapy differs between patients treated with VKA (e.g. Phenprocoumon) and patients treated with Apixaban, Dabigatran or Rivaroxaban respectively. Country of study Germany Author Fabian Volz Pfizer Deutschland Linkstraße 10 10785 Berlin [email protected] Josephine Jacob Elsevier Health Analytics Jägerstraße 41 Pfizer Confidential Page 2 of 112 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Update 1, 08 January 2016 10117 Berlin [email protected] Bristol-Myers Squibb/Pfizer EEIG Marketing Authorisation Holder(s) Bristol-Myers Squibb House Uxbridge Business Park Sanderson Road, Uxbridge Middlesex UB8 1DH United Kingdom MAH contact person Fabian Volz This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold this information in confidence and not copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified. Pfizer Confidential Page 3 of 112 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Update 1, 08 January 2016 TABLE OF CONTENTS TABLE OF CONTENTS ...........................................................................................................4 1. LIST OF ABBREVIATIONS ................................................................................................6 2. RESPONSIBLE PARTIES ....................................................................................................9 3. ABSTRACT .........................................................................................................................11 4. AMENDMENTS AND UPDATES .....................................................................................14 4.1. Update 1: Update of original study protocol from September, 9th 2015: ................14 5. MILESTONES .....................................................................................................................15 6. RATIONALE AND BACKGROUND ................................................................................17 7. RESEARCH QUESTION AND OBJECTIVES .................................................................18 8. RESEARCH METHODS ....................................................................................................19 8.1. Study design ............................................................................................................19 8.2. Setting ......................................................................................................................19 8.2.1. Inclusion criteria .........................................................................................19 8.2.2. Exclusion criteria ........................................................................................20 8.2.3. Observation periods ....................................................................................21 8.3. Variables ..................................................................................................................26 8.3.1. Outcomes/ Endpoint Variable .....................................................................26 8.3.2. Factors affecting censoring during follow up .............................................29 8.3.3. Exposure Variables / Independent Variables of Interest ............................30 8.3.4. Other Covariates .........................................................................................31 8.4. Data sources ............................................................................................................44 8.5. Study size ................................................................................................................45 8.5.1. Preliminary feasibility study -- sample size assessment and power analysis .............................................................................................................45 8.6. Data management ....................................................................................................47 8.7. Data analysis ...........................................................................................................48 8.7.1. Demographic and clinical characteristics ...................................................48 8.7.2. Time to bleeding – Scenario I ‘On treatment’ ............................................49 8.7.3. Time to bleeding – scenario II ‘Treatment Switching’ ...............................50 8.7.4. Days of VKA supply – Global Option .......................................................53 8.7.5. Additional analyses – pairwise comparisons ..............................................54 Pfizer Confidential Page 4 of 112 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Update 1, 08 January 2016 8.7.6. Additional analyses – NOAC comparison ..................................................55 8.8. Quality control .........................................................................................................55 8.8.1. HRI Data quality management ...................................................................55 8.9. Limitations of the research methods .......................................................................57 8.10. Other aspects .........................................................................................................57 9. PROTECTION OF HUMAN SUBJECTS ..........................................................................58 9.1. Patient Information and Consent .............................................................................58 9.2. Patient withdrawal ...................................................................................................58 9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............58 9.4. Ethical Conduct of the Study ..................................................................................58 10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS ......................................................................................................................59 11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........59 12. REFERENCES ..................................................................................................................60 13. LIST OF TABLES .............................................................................................................61 14. LIST OF FIGURES ...........................................................................................................61 ANNEX 1.................................................................................................................................62 ANNEX 2.................................................................................................................................62 ANNEX 3.................................................................................................................................63 ANNEX 4...............................................................................................................................106 ANNEX 5...............................................................................................................................109 15. AMENDMENT................................................................................................................110 15.1. Research questions and objectives ......................................................................110 15.2. Research methods ................................................................................................110 15.2.1. Setting .....................................................................................................110 15.2.2. Variables .................................................................................................110 15.3. Data analysis .......................................................................................................111 15.3.1. Additional analyses – dosage analyses ...................................................111 Pfizer Confidential Page 5 of 112
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