3061 Finalised Comparative Effectiveness of Oral Anticoagulants: A Cohort Study No Yes 3064 Finalised A description of warfarin and new oral anticoagulant utilization patterns including initiation, switching, and discontinuation: Phase 3 of the BI/BWH... No Yes 4290 Finalised A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE study... No No 4373 Finalised A description of oral and non-insulin injected hypoglycemic therapy utilization patterns including initiation, switching, and discontinuation... No No 5214 Finalised An observational study assessing the management of gastrointestinal and urogenital bleeding events in patients with atrial fibrillation treated with... No Yes 5790 Ongoing Active surveillance research program for the assessment of the safety and the effectiveness of linagliptin No No 5855 Finalised Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study No Yes 6134 Finalised Combined bronchodilators in COPD and the risk of adverse cardio-pulmonary events: A population-based observational study (Comb Bronchodil in COPD and... No Yes 6352 Finalised Modified Prescription-Event Monitoring Study to Monitor the Introduction of Atrovent Inhaler CFC-Free® MDI in the United Kingdom (Atrovent CFC-free... No No 6568 Planned A retrospective cohort study with chart review to assess the management of major bleeding events in NVAF patients treated with dabigatran etexilate No No 6616 Finalised Real-life anticoagulants benefit-risk in atrial fibrillation (AF) in France: VKA benefit-risk assessment before DOAC use for AF (ENGEL 1 VKA) No No 6804 Finalised Metabolic effects associated with ICS (inhaled corticosteroid) use in COPD (chronic obstructive pulmonary disease) patients with type II diabetes Yes No 7591 Finalised Evaluation of potential off-label use of dabigatran etexilate in Europe Yes Yes 7727 Finalised Randomised Controlled Trial (RCT) vs Real Life initiative (RCT vs Real Life) No No 8525 Finalised Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA (PRODAST) Yes Yes 9111 Finalised Post-authorisation study to evaluate the effectiveness of the risk minimisation activities in the treatment of SPAF (Risk minimisation in SPAF) No Yes 9364 Ongoing A regulatory requirement post-marketing surveillance study to monitor the safety and efficacy of GIOTRIF®(afatinib dimaleate, 20mg, 30mg, 40mg, q.d)... No No 9374 Ongoing Stroke Prevention and anticoagulants (SPA) Yes No 9771 Ongoing The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation... No No 10457 Finalised Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamin K... No No 10945 Ongoing The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation Patient Population-A... No No 11368 Ongoing ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of safety and effectiveness of dabigatran etexilate (DE) in... Yes No 11885 Finalised A non-interventional biomarker study in patients with Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology eligible for treatment... No No 11924 Ongoing Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamine K... No No 12709 Finalised Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 12750 Finalised Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 12795 Ongoing Vargatef in 2nd-line therapy of advanced or metastatic adenocarcinoma of the lung (VARGADO) No No 12864 Ongoing Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 12878 Ongoing Dabigatran study in the early phase of stroke. New neuroimaging markers and biomarkers study (SEDMAN STUDY) No No 12954 Ongoing Evaluation of the impact of a nurse-led telephone follow-up on treatment compliance of patients treated from a locally advanced or metastatic... No No 13167 Ongoing RealGiDo: Real-world data on Gi(l)otrif® dose adjustment in first-line treatment, TKI-naïve, advanced non-small cell lung cancer patients with EGFR... Yes No 13390 Finalised Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K... Yes Yes 13413 Finalised Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic... Yes Yes 13605 Ongoing SATisfaction and adherence to COPD treatment No No 13627 Ongoing A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE® (empagliflozin 10mg, 25mg) in Korean patients... No No 13672 Finalised Non-interventional study describing treatment convenience in patients treated with Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)... No Yes 14507 Finalised Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom (Empa DUS in UK) Yes Yes 14956 Finalised A regulatory required non interventional study to monitor the safety and effectiveness of once daily treatment of orally inhaled Vahelva Respimat... No No 15008 Planned Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to... Yes No 16314 Planned Validation of predictors for oral anticoagulant medication choice using EMR data No No 16424 Ongoing Post-authorisation safety study to assess the risk of urinary tract malignancies in relation to empagliflozin exposure in patients with type 2... Yes No 16528 Finalised The Comparative Safety and Effectiveness of dabigatran, versus rivaroxaban, and apixaban Utilized in the Department of Defense (DoD) Non-Valvular... No No 16629 Planned Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 16988 Finalised Non-Interventional, cross-sectional study to describe health-related quality of life among controlled and uncontrolled patients with nonvalvular... No Yes 17055 Finalised An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis Yes Yes 17078 Finalised An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or... Yes Yes 17165 Finalised Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A retrospective analysis from the SITS-AF Registry on treatment initiation of dabigatran... Yes Yes 17386 Finalised Drug Utilisation Study for Olodaterol Yes Yes 17922 Planned Clinical characteristics, anti-hyperglycaemic treatment pattern and target attainment of type 2 diabetes mellitus patients in older population with or... No No 18150 Planned Post Authorization Safety Study of Nintedanib in the treatment of patients with Idiopathic Pulmonary fibrosis in Argentina Yes No 18745 Finalised AERIAL®: Changes in health and functional status in patients with COPD during therapy with Spiolto® Respimat® No No 19384 Finalised A multicentre, retrospective chart review study to describe the clinical profile of idiopathic pulmonary fibrosis (IPF) patients treated with... No Yes 19558 Ongoing Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation --- Impact of Conventional Oral Anticoagulant (OAC) Compared With... No No 19865 Ongoing Non-Interventional study (NIS) Collecting Experiences For IPF in Taiwan (NICEFIT) No No 20025 Ongoing Post-authorization safety study in patients with type 2 diabetes mellitus to assess the incidence of ketoacidosis, severe complications of urinary... Yes No 20677 Ongoing Non-interventional study on the effectiveness and safety of Empagliflozin compared with DPP-4 inhibitors in patients with type 2 diabetes in the... No No 21037 Finalised GioTag: Real-world data study on sequential therapy with Gi(l)otrif®/ afatinib as first-line treatment followed by osimertinib in patients with EGFR... No No 21422 Planned Changes in functional status in patients with Chronic Obstructive Pulmonary Disease (COPD) during therapy with Spiolto® Respimat® (ELLACTO) No No 21548 Ongoing Real world glycemic effectiveness of linagliptin (Tradjenta®) among type 2 diabetes mellitus adults by age and renal function. No No 21574 Finalised Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists Yes Yes 21696 Ongoing A 5-year enhanced Pharmacovigilance surveillance initiative to survey and characterise spontaneous occurrence and experience of ketoacidotic events in... Yes No 21699 Finalised Comparative effectiveness of combination therapies in COPD No Yes 22002 Finalised Global Evaluation of the Interstitial Lung Disease Diagnostic Pathway (Global ILD-MDT study) Yes No 23589 Planned Safety of potential paediatric patients treated by idarucizumab: a worldwide non-interventional chart review study (Pediatric NIS) No No 24004 Ongoing A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE DUO® (empagliflozin/metformin, 5/500mg,... No No 25626 Ongoing Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 25682 Planned Characteristics of patients initiating Spiriva Respimat in Asthma in the UK: a cross-sectional study based on the Clinical Practice Research Datalink No No 26211 Ongoing Comparative effectiveness of triple therapy in COPD: A new-user cohort study Yes No 26481 Ongoing Empagliflozin effectiveness in a real-world population replicating the DECLARE - TIMI58 trial No No 27606 Finalised Multi-country non-interventional study on the effectiveness and safety of Empagliflozin in adult patients with type 2 diabetes in Europe and Asia Yes Yes 28505 Finalised CORDIALLY® - CEE: Characteristics of patients with Type 2 Diabetes treated with modern antidiabetic drugs. A real world data collection of patient... No Yes 29401 Planned Advancing the Patient Experience in COPD Registry (APEX COPD) No No 29784 Ongoing Assessment of dyspnea and other symptoms as patient reported outcomes (PRO) in patients with chronic obstructive pulmonary disease (COPD), symptomatic... No No 29889 Ongoing The effectiveness of Tiotropium Add-on therapy using a Real-world cohort of patients with Asthma (Tiotropium therapy in Asthma) Yes No 29985 Ongoing Cardiovascular and renal outcomes, and mortality in Danish patients with type 2 diabetes who initiate empagliflozin versus GLP1-RA: A Danish... Yes No 30039 Finalised Characteristics of IPF patients initiating nintedanib, pirfenidone or no antifibrotic treatment in the US Yes No 30087 Planned Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease (TOReTO) Yes No 30293 Finalised A real-world non-interventional study to assess patient satisfaction with and preference for re-usable Respimat Soft Mist inhaler in patients with... Yes No 30838 Ongoing The Role of Inhaler Device in the Treatment Persistence with Dual Bronchodilators in Patients with COPD No No 30851 Finalised Implications of ICS withdrawal in the real-life management of COPD No No 31146 Ongoing Epidemiology, treatment and healthcare utilization in patients with diabetes mellitus – a population-based observational study using data from the... No No 31932 Planned Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in comparison to Maintenance Treatment with a... No No 31940 Planned Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance... No No 31950 Ongoing Empagliflozin vs. DPP-4 inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German claims data analysis No No 32098 Planned UpSwinG: Real World study on TKI activity in Uncommon mutations and Sequencing Giotrif® No No 32329 Ongoing Comparing the Incidence between Tiotropium and ICS/LABA in Real world Use in South Korea (CITRUS study) No No 32862 Ongoing Profiling Inhalation Medication in COPD patients (PRIME) No No 33011 Planned Safe Implementation of Treatments in Stroke (SITS) - Intravenous thrombolysis in acute ischaemic stroke patients over 80 years, SITS-IVT>80 years... No No 33426 Ongoing Early Intervention Efficacy of Tiotropium/Olodaterol Compared to Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (Early Intervention... No No 33970 Planned Temporal trends of thrombolysis treatment in Chinese acute ischemic stroke (AIS) patients from 2007 2017: analysis of China National Stroke Registry... No No 33973 Planned Temporal trends of thrombolysis treatment in Chinese acute ischemic stroke (AIS) patients from 2007 2017: analysis of China National Stroke Registry... No No 34689 Ongoing Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations (PIF in COPD) No No 34861 Finalised Incidence and Prevalence of Interstitial Lung Disease and their progressive fibrosing phenotypes in 6 European Countries (PERSEIDS) Yes Yes 35014 Finalised Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment with a... Yes Yes 35224 Ongoing Association of eGFR slope and cardiovascular/renal events or all-cause deaths in Japanese database (eGFR slope and death) Yes No 35286 Ongoing Burden of Disease of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada: A Non-interventional... No No 37649 Planned Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy (NICEFIT ON) No No 38023 Planned Clinical characteristics and disease burden of patients with diabetes mellitus combined with cardiovascular or chronic kidney disease based on... No No 38026 Planned Characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease,... No No 38272 Ongoing Prospective observational investigation of possible correlations between change in FVC and change in cough or dyspnea scores using the living with... No No 39461 Finalised A Meta-Analysis of Amputation Risk in empagliflozin studies (1245.25, 1245.110, 1245.121) Yes Yes 39494 Finalised Expert opinion on the impact of inhaler choice on climate change and personalised healthcare Yes No 40026 Finalised A Phase I trial to investigate the effect of nintedanib on the pharmacokinetics of a combination of ethinylestradiol and levonorgestrel in female... No Yes 41157 Finalised Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in Combination with Chemotherapy for Treatment of Metastatic Squamous Cell... Yes Yes 41509 Planned Characteristics and in-hospital outcomes of Chinese elderly (>80 years) patients with acute ischemic stroke receiving intravenous recombinant tissue... No No 42653 Planned Real-World Medication Adherence Trajectories to Nintedanib among Idiopathic Pulmonary Fibrosis Patients No No 43164 Finalised Assessment of Real-World Outcomes Associated with Afatinib (Gilotrif) Use in Patients with Solid Tumors Harboring NRG1 Gene Fusions (Afatinib... Yes Yes 43167 Ongoing Health Care Resource Utilization, Cost and Other Outcomes of Patients Diagnosed with COPD Initiating Tiotropium Bromide/Olodaterol versus Fluticasone... No No 44101 Ongoing Exacerbation Risk and Health Care Resource use among patients with asthma using ICS+Tiotropium versus ICS/LABA No No 44267 Finalised Post-authorization safety study (PASS) to assess the risk of acute pancreatitis in type 2 diabetes mellitus (T2DM) patients newly initiating... Yes Yes 44579 Ongoing A regulatory requirement non-interventional study to monitor the safety and effectiveness of Glyxambi (empagliflozin/linagliptin, 10/5mg, 25/5mg) in... No No 44641 Planned A regulatory requirement non-interventional study to monitor the safety and effectiveness of Jardiance® (empagliflozin, 10mg) in Korean patients with... No No 45682 Ongoing Comparative cardiovascular and renal effectiveness and safety of Empagliflozin and other SGLT2i in patients with type 2 diabetes (T2D), with and... No No 46175 Finalised A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess... Yes No 47537 Finalised Global Evaluation of the Interstitial Lung Disease (ILD) Diagnostic Pathway in the Post-COVID Era (ILD vMDT) Yes No 47909 Planned Safety of dabigatran etexilate (DE) for treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from birth to... No No 48472 Finalised Comparison of Exacerbation Risk and Health Outcomes in Maintenance Treatment Naïve COPD patients using Stiolto vs. Trelegy No No 49653 Planned A prospective, observational study on the correlations between change in lung function and change in cough and dyspnoea in patients with connective... No No 103733 Planned Non-interventional study of patients with Netherton Syndrome to characterise the natural history of disease (Natural history of Netherton Syndrome) No No 106700 Planned Non-interventional study of the effectiveness and safety of Jardiance in patients with heart failure (HF) of reduced ejection fraction (HFrEF)... No No 106763 Planned A non-interventional study of the effectiveness and safety outcomes in patients with heart failure and preserved ejection fraction (HFpEF) initiating... No No 106792 Planned Non-interventional post-authorization effectiveness study to assess long-term outcomes of Nintedanib treatment in patients with systemic sclerosis... No No