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NVA237 / Glycopyrronium Bromide Multinational, Multi-Database Drug

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NVA237 / Glycopyrronium Bromide Multinational, Multi-Database Drug Quantitative Safety & Epidemiology NVA237 / Glycopyrronium bromide Non-interventional Final Study Report NVA237A2401T Multinational, multi-database drug utilization study of inhaled NVA237 in Europe Author Document Status Final Date of final version 28 April 2016 of the study report EU PAS register ENCEPP/SDPP/4845 number Property of Novartis Confidential May not be used, divulged, published or otherwise disclosed without the consent of Novartis NIS Report Template Version 2.0 August-13-2014 Novartis Confidential Page 2 Non-interventional study report NVA237A/Seebri® Breezhaler®/CNVA237A2401T PASS information Title Multinational, multi-database drug utilization study of inhaled NVA237 in Europe –Final Study Report Version identifier of the Version 1.0 final study report Date of last version of 28 April 2016 the final study report EU PAS register number ENCEPP/SDPP/4845 Active substance Glycopyrronium bromide (R03BB06) Medicinal product Seebri®Breezhaler® / Tovanor®Breezhaler® / Enurev®Breezhaler® Product reference NVA237 Procedure number SeebriBreezhaler: EMEA/H/C/0002430 TovanorBreezhaler: EMEA/H/C/0002690 EnurevBreezhaler: EMEA/H/C0002691 Marketing authorization Novartis Europharm Ltd holder Frimley Business Park Camberley GU16 7SR United Kingdom Joint PASS No Research question and In the context of the NVA237 marketing authorization objectives application, the Committee for Medicinal Products for Human Use (CHMP) recommended conditions for marketing authorization and product information and suggested to conduct a post-authorization drug utilization study. The objectives of this study are to estimate the subpopulation with cardio- and cerebrovascular co-morbidity and to identify patient groups with missing information as per the Risk Management Plan. Country(-ies) of study United Kingdom, Denmark, Italy, The Netherlands, Spain 2 Novartis Confidential Page 4 Non-interventional study report NVA237A/Seebri® Breezhaler®/CNVA237A2401T Table of contents Table of contents .................................................................................................................4 List of tables ........................................................................................................................6 List of figures ......................................................................................................................7 1 Abstract................................................................................................................................9 2 List of abbreviations ..........................................................................................................13 3 Investigators ......................................................................................................................15 4 Other responsible parties ...................................................................................................16 5 Milestones..........................................................................................................................16 6 Rationale and background .................................................................................................17 7 Research question and objectives......................................................................................18 7.1 Main objectives......................................................................................................18 7.2 Secondary objectives .............................................................................................19 8 Amendments and updates to the protocol .........................................................................19 9 Research methods..............................................................................................................21 9.1 Study design...........................................................................................................21 9.2 Setting....................................................................................................................22 9.3 Subjects..................................................................................................................23 9.3.1 In- and exclusion criteria.......................................................................23 9.3.2 Follow-up ..............................................................................................23 9.4 Variables ................................................................................................................23 9.4.1 NVA237-exposure and duration of use.................................................23 9.4.2 Demography, life-style factors and COPD characteristics prior to time of first prescription........................................................................24 9.4.3 Indication of use of inhaled NVA237 ...................................................25 9.4.4 Prescribed dosage/posology..................................................................25 9.4.5 Concomitant use of other respiratory medications................................26 9.4.6 Concomitant use of systemic anticholinergic medications ...................26 9.4.7 Underlying co-morbidities ....................................................................27 9.4.8 Pregnancy or breastfeeding at initiation of NVA237............................27 9.5 Data sources and measurement..............................................................................27 9.6 Bias ........................................................................................................................29 9.7 Study size...............................................................................................................30 9.8 Data transformation ...............................................................................................30 9.9 Statistical methods.................................................................................................32 9.9.1 Main summary measures.......................................................................32 4 Novartis Confidential Page 5 Non-interventional study report NVA237A/Seebri® Breezhaler®/CNVA237A2401T 9.9.2 Main statistical methods........................................................................33 9.9.3 Missing values.......................................................................................33 9.9.4 Sensitivity analyses ...............................................................................33 9.9.5 Amendments to the statistical analysis plan..........................................33 9.10 Quality control .......................................................................................................33 10 Results ...............................................................................................................................33 10.1 Participants ............................................................................................................33 10.2 Descriptive data .....................................................................................................34 10.2.1 Baseline characteristics of NVA237 users............................................34 10.2.2 COPD characteristics of patients initiating NVA237 ...........................38 10.2.3 Prescribed dosage and treatment duration of NVA237.........................38 10.2.4 Co-morbidity in patients initiating NVA237 ........................................40 10.2.5 Use of other medications in patients initiating NVA237 ......................40 10.3 Outcome data.........................................................................................................41 10.4 Main results ...........................................................................................................41 10.4.1 Cardiovascular and cerebrovascular comorbidities ..............................41 10.4.2 Missing information in the RMP and high risk treatment conditions...42 10.4.3 Uninterrupted use of NVA237 for more than one year.........................43 10.4.4 Off-label use of NVA237......................................................................46 10.5 Other analyses........................................................................................................48 10.5.1 Pediatric patients ...................................................................................48 10.6 Adverse events/adverse reactions ..........................................................................48 11 Discussion..........................................................................................................................48 11.1 Key results .............................................................................................................48 11.2 Limitations.............................................................................................................49 11.3 Interpretation..........................................................................................................51 12 Generalizability .................................................................................................................54 13 Other information ..............................................................................................................54 14 Conclusion.........................................................................................................................55 15 References (available upon request)..................................................................................55 16 Appendices
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