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NON-INTERVENTIONAL (NI) STUDY PROTOCOL Post Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 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 Final 1.0 Date of last version of protocol 22 September 2015 EU Post Authorisation Study (PAS) NOTE: Please ensure this number is register number entered 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 103 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 EU/1/11/691/012 EU/1/11/691/014 Procedure number Not Available Marketing Authorisation Holder (MAH) Bristol-Myers Squibb/Pfizer EEIG 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 Sebastian Kloss Pfizer Deutschland GmbH Linkstraße 10 10785 Berlin [email protected] Josephine Jacob Elsevier Health Analytics Jägerstraße 41 Pfizer Confidential Page 2 of 103 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 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 Sebastian Kloss 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 103 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 TABLE OF CONTENTS TABLE OF CONTENTS ...........................................................................................................4 1. LIST OF ABBREVIATIONS ................................................................................................6 2. RESPONSIBLE PARTIES ....................................................................................................9 3. ABSTRACT .........................................................................................................................11 4. AMENDMENTS AND UPDATES .....................................................................................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 ....................................................................................24 8.3. Variables ..................................................................................................................28 8.3.1. Outcomes/ Endpoint Variable .....................................................................29 8.3.2. Factors affecting censoring during follow up .............................................31 8.3.3. Exposure Variables / Independent Variables of Interest ............................32 8.3.4. Other Covariates .........................................................................................33 8.4. Data sources ............................................................................................................45 8.5. Study size ................................................................................................................46 8.5.1. Preliminary feasibility study -- sample size assessment and power analysis .............................................................................................................46 8.6. Data management ....................................................................................................49 8.7. Data analysis ...........................................................................................................49 8.7.1. Demographic and clinical characteristics ...................................................49 8.7.2. Time to bleeding – Scenario I ‘On treatment’ ............................................50 8.7.3. Time to bleeding – scenario II ‘Treatment Switching’ ...............................52 8.7.4. Days of VKA supply – Global Option .......................................................55 8.7.5. Additional analyses – pairwise comparisons ..............................................55 8.7.6. Additional analyses – NOAC comparison ..................................................56 Pfizer Confidential Page 4 of 103 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 8.8. Quality control .........................................................................................................56 8.8.1. HRI Data quality management ...................................................................56 8.9. Limitations of the research methods .......................................................................58 8.10. Other aspects .........................................................................................................59 9. PROTECTION OF HUMAN SUBJECTS ..........................................................................59 9.1. Patient Information and Consent .............................................................................59 9.2. Patient withdrawal ...................................................................................................59 9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............59 9.4. Ethical Conduct of the Study ..................................................................................60 10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE REACTIONS ......................................................................................................................60 11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........60 12. REFERENCES ..................................................................................................................62 13. LIST OF TABLES .............................................................................................................63 14. LIST OF FIGURES ...........................................................................................................63 ANNEX 1.................................................................................................................................64 ANNEX 2.................................................................................................................................64 ANNEX 3.................................................................................................................................65 ANNEX 4...............................................................................................................................100 ANNEX 5...............................................................................................................................103 Pfizer Confidential Page 5 of 103 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 1. LIST OF ABBREVIATIONS Abbreviation Definition AE Adverse Events NVAF Non-Valvular Atrial Fibrillation ATC Anatomical Therapeutic Chemical Classification System CCI Charlson Comorbidity Index CI Confidence Interval DDD Defined Daily Dose DVT Deep Vein Thrombosis EBM Einheitlicher Bewertungsmaßstab EHA Elsevier Health Analytics EU European Union FDA Food and Drug Administration Pfizer Confidential Page 6 of 103 Apixaban B0661069 NON-INTERVENTIONAL STUDY PROTOCOL Final, 22 September 2015 GI Gastrointestinal GOP Gebührenordnungsposition HRI Health Risk Institute ICD-10 GM International Classification of Diseases, 10th Revision, German Modification ICH Intracerebral Hemorrhage INR International Normalized Ratio NI Non-Interventional NOAC Novel Oral Anticoagulants NSAID Non-Steroidal Anti-Inflammatory
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