PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 3061 Finalised Unspecified Comparative Effectiveness of Oral Anticoagulants: A Cohort Study No Yes 3064 Finalised Not included in RMP 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 EU RMP category 3 A multicenter, international, randomized, parallel group, double-blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcomE study... No No 4373 Finalised Unspecified A description of oral and non-insulin injected hypoglycemic therapy utilization patterns including initiation, switching, and discontinuation... No No 5214 Finalised Not included in RMP An observational study assessing the management of gastrointestinal and urogenital bleeding events in patients with atrial fibrillation treated with... No Yes 5790 Ongoing Unspecified Active surveillance research program for the assessment of the safety and the effectiveness of linagliptin No No 5855 Finalised Not included in RMP Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study No Yes 6134 Finalised Not included in RMP 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 Not included in RMP 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 Unspecified 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 Not included in RMP 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 Unspecified Metabolic effects associated with ICS (inhaled corticosteroid) use in COPD (chronic obstructive pulmonary disease) patients with type II diabetes Yes No 7591 Finalised EU RMP category 3 Evaluation of potential off-label use of dabigatran etexilate in Europe Yes Yes 7727 Finalised Not included in RMP Randomised Controlled Trial (RCT) vs Real Life initiative (RCT vs Real Life) No No 8525 Finalised Not included in RMP Prospective Record Of the use of Dabigatran in patients with Acute Stroke or TIA (PRODAST) Yes Yes 9111 Finalised Unspecified 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 Not included in RMP 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 Not included in RMP Stroke Prevention and anticoagulants (SPA) Yes No 9771 Ongoing Unspecified The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Department of Defense (DoD) Non-Valvular Atrial Fibrillation... No No 10457 Finalised Not included in RMP Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamin K... No No 10945 Ongoing Unspecified The Comparative Safety and Effectiveness of Warfarin and Dabigatran Utilized in the Humana Non-Valvular Atrial Fibrillation Patient Population-A... No No 11368 Ongoing Not included in RMP ChaRactErization of patients following aCute venous thrOmboembolism (VTE) and assessment of safety and effectiveness of dabigatran etexilate (DE) in... Yes No 11885 Finalised Not included in RMP 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 Unspecified Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamine K... No No 12709 Finalised Not included in RMP Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 12750 Finalised Not included in RMP Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 12795 Ongoing Not included in RMP Vargatef in 2nd-line therapy of advanced or metastatic adenocarcinoma of the lung (VARGADO) No No 12864 Ongoing Unspecified Assessment of physical functioning and handling of Spiolto Respimat in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 12878 Ongoing Not included in RMP Dabigatran study in the early phase of stroke. New neuroimaging markers and biomarkers study (SEDMAN STUDY) No No 12954 Ongoing Unspecified 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 Not included in RMP 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-EU RMP-only Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K... Yes Yes 13413 Finalised EU RMP category 3 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 Unspecified SATisfaction and adherence to COPD treatment No No 13627 Ongoing EU RMP category 1 A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE® (empagliflozin 10mg, 25mg) in Korean patients... No No 13672 Finalised Not included in RMP Non-interventional study describing treatment convenience in patients treated with Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)... No Yes 14507 Finalised EU RMP category 3 Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom (Empa DUS in UK) Yes Yes 14956 Finalised Not included in RMP 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 Not included in RMP Observational prospective cohort study to evaluate the incidence of adverse events (AE), risk factors, and drug utilization patterns related to... Yes No 16314 Planned Not included in RMP Validation of predictors for oral anticoagulant medication choice using EMR data No No 16424 Ongoing EU RMP category 3 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 Not included in RMP The Comparative Safety and Effectiveness of dabigatran, versus rivaroxaban, and apixaban Utilized in the Department of Defense (DoD) Non-Valvular... No No 16629 Planned Not included in RMP Assessment of physical functioning and handling of Spiolto® Respimat® in patients with chronic obstructive pulmonary disease (COPD) requiring... No No 16988 Finalised Not included in RMP Non-Interventional, cross-sectional study to describe health-related quality of life among controlled and uncontrolled patients with nonvalvular... No Yes 17055 Finalised Not included in RMP 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 Non-EU RMP-only 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 Not included in RMP 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 EU RMP category 2 Drug Utilisation Study for Olodaterol Yes Yes 17922 Planned Not included in RMP Clinical characteristics, anti-hyperglycaemic treatment pattern and target attainment of type 2 diabetes mellitus patients in older population with or... No No 18150 Planned Not included in RMP Post Authorization Safety Study of Nintedanib in the treatment of patients with Idiopathic Pulmonary fibrosis in Argentina Yes No 18745 Finalised Not included in RMP AERIAL®: Changes in health and functional status in patients with COPD during therapy with Spiolto® Respimat® No No 19384 Finalised Not included in RMP A multicentre, retrospective chart review study to describe the clinical profile of idiopathic pulmonary fibrosis (IPF) patients treated with... No Yes 19558 Ongoing Not included in RMP Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation --- Impact of Conventional Oral Anticoagulant (OAC) Compared With... No No 19865 Ongoing Not included in RMP Non-Interventional study (NIS) Collecting Experiences For IPF in Taiwan (NICEFIT) No No 20025 Ongoing Non-EU RMP-only 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 Not included in RMP 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 Not included in RMP 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 Not included in RMP Changes in functional status in patients with Chronic Obstructive Pulmonary Disease (COPD) during therapy with Spiolto® Respimat® (ELLACTO) No No 21548 Ongoing Not included in RMP Real world glycemic effectiveness of linagliptin (Tradjenta®) among type 2 diabetes mellitus adults by age and renal function. No No 21574 Finalised EU RMP category 2 Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists Yes Yes 21696 Ongoing EU RMP category 3 A 5-year enhanced Pharmacovigilance surveillance initiative to survey and characterise spontaneous occurrence and experience of ketoacidotic events in... Yes No 21699 Finalised Not included in RMP Comparative effectiveness of combination therapies in COPD No Yes 22002 Finalised Not included in RMP Global Evaluation of the Interstitial Lung Disease Diagnostic Pathway (Global ILD-MDT study) Yes No 23589 Planned Not included in RMP Safety of potential paediatric patients treated by idarucizumab: a worldwide non-interventional chart review study (Pediatric NIS) No No 24004 Ongoing Not included in RMP A regulatory requirement non interventional study to monitor the safety and effectiveness of JARDIANCE DUO® (empagliflozin/metformin, 5/500mg,... No No 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 25682 Planned Not included in RMP 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 Not included in RMP Comparative effectiveness of triple therapy in COPD: A new-user cohort study Yes No 26481 Ongoing Not included in RMP Empagliflozin effectiveness in a real-world population replicating the DECLARE - TIMI58 trial No No 27606 Finalised Not included in RMP 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 Not included in RMP 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 Not included in RMP Advancing the Patient Experience in COPD Registry (APEX COPD) No No 29784 Ongoing Not included in RMP Assessment of dyspnea and other symptoms as patient reported outcomes (PRO) in patients with chronic obstructive pulmonary disease (COPD), symptomatic... No No 29889 Ongoing Not included in RMP The effectiveness of Tiotropium Add-on therapy using a Real-world cohort of patients with Asthma (Tiotropium therapy in Asthma) Yes No 29985 Ongoing Not included in RMP 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 Not included in RMP Characteristics of IPF patients initiating nintedanib, pirfenidone or no antifibrotic treatment in the US Yes No 30087 Planned Not included in RMP Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease (TOReTO) Yes No 30293 Finalised Not included in RMP 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 Not included in RMP The Role of Inhaler Device in the Treatment Persistence with Dual Bronchodilators in Patients with COPD No No 30851 Finalised Not included in RMP Implications of ICS withdrawal in the real-life management of COPD No No 31146 Ongoing Not included in RMP Epidemiology, treatment and healthcare utilization in patients with diabetes mellitus – a population-based observational study using data from the... No No 31932 Planned Not included in RMP Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in comparison to Maintenance Treatment with a... No No 31940 Planned Not included in RMP Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance... No No 31950 Ongoing Not included in RMP Empagliflozin vs. DPP-4 inhibitors and GLP-1 Receptor Agonists Cost of Care Study: a German claims data analysis No No 32098 Planned Not included in RMP UpSwinG: Real World study on TKI activity in Uncommon mutations and Sequencing Giotrif® No No 32329 Ongoing Not included in RMP Comparing the Incidence between Tiotropium and ICS/LABA in Real world Use in South Korea (CITRUS study) No No 32862 Ongoing Not included in RMP Profiling Inhalation Medication in COPD patients (PRIME) No No 33011 Planned Not included in RMP 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 Not included in RMP Early Intervention Efficacy of Tiotropium/Olodaterol Compared to Tiotropium in Chronic Obstructive Pulmonary Disease (COPD) (Early Intervention... No No 33970 Planned Not included in RMP 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 Not included in RMP 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 Not included in RMP Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations (PIF in COPD) No No 34861 Finalised Not included in RMP Incidence and Prevalence of Interstitial Lung Disease and their progressive fibrosing phenotypes in 6 European Countries (PERSEIDS) Yes Yes 35014 Finalised Not included in RMP Effectiveness and Safety of Maintenance Treatment with Combination of Tiotropium and Olodaterol in Comparison to Maintenance Treatment with a... Yes Yes 35224 Ongoing Not included in RMP Association of eGFR slope and cardiovascular/renal events or all-cause deaths in Japanese database (eGFR slope and death) Yes No 35286 Ongoing Not included in RMP 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 Not included in RMP Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy (NICEFIT ON) No No 38023 Planned Not included in RMP Clinical characteristics and disease burden of patients with diabetes mellitus combined with cardiovascular or chronic kidney disease based on... No No 38026 Planned Not included in RMP Characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease,... No No 38272 Ongoing Not included in RMP 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 EU RMP category 3 A Meta-Analysis of Amputation Risk in empagliflozin studies (1245.25, 1245.110, 1245.121) Yes Yes 39494 Finalised Not included in RMP Expert opinion on the impact of inhaler choice on climate change and personalised healthcare Yes No 40026 Finalised Not included in RMP 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 Not included in RMP Real-World Effectiveness of Afatinib (Gilotrif) Following Immunotherapy in Combination with Chemotherapy for Treatment of Metastatic Squamous Cell... Yes Yes 41509 Planned Not included in RMP Characteristics and in-hospital outcomes of Chinese elderly (>80 years) patients with acute ischemic stroke receiving intravenous recombinant tissue... No No 42653 Planned Non-EU RMP-only Real-World Medication Adherence Trajectories to Nintedanib among Idiopathic Pulmonary Fibrosis Patients No No 43164 Finalised Not included in RMP Assessment of Real-World Outcomes Associated with Afatinib (Gilotrif) Use in Patients with Solid Tumors Harboring NRG1 Gene Fusions (Afatinib... Yes Yes 43167 Ongoing Not included in RMP Health Care Resource Utilization, Cost and Other Outcomes of Patients Diagnosed with COPD Initiating Tiotropium Bromide/Olodaterol versus Fluticasone... No No 44101 Ongoing Not included in RMP Exacerbation Risk and Health Care Resource use among patients with asthma using ICS+Tiotropium versus ICS/LABA No No 44267 Finalised Not included in RMP 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 Not included in RMP 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 Not included in RMP A regulatory requirement non-interventional study to monitor the safety and effectiveness of Jardiance® (empagliflozin, 10mg) in Korean patients with... No No 45682 Ongoing Not included in RMP 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 EU RMP category 3 A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess... Yes No 47537 Finalised Not included in RMP Global Evaluation of the Interstitial Lung Disease (ILD) Diagnostic Pathway in the Post-COVID Era (ILD vMDT) Yes No 47909 Planned EU RMP category 3 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 Not included in RMP Comparison of Exacerbation Risk and Health Outcomes in Maintenance Treatment Naïve COPD patients using Stiolto vs. Trelegy No No 49653 Planned Not included in RMP 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 Not included in RMP Non-interventional study of patients with Netherton Syndrome to characterise the natural history of disease (Natural history of Netherton Syndrome) No No 106700 Planned Not included in RMP 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 Not included in RMP 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 Not included in RMP Non-interventional post-authorization effectiveness study to assess long-term outcomes of Nintedanib treatment in patients with systemic sclerosis... No No