PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 2353 Finalised Not included in RMP The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources Yes No 2356 Finalised Not included in RMP Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish... Yes Yes 2382 Finalised Not included in RMP Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design Yes No 2385 Ongoing Unspecified Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Yes No 2388 Ongoing Unspecified Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of... Yes No 2561 Ongoing Unspecified Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data... Yes No 3287 Finalised EU RMP category 3 Assessment of physician behaviour regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL®... Yes Yes 3292 Finalised EU RMP category 3 Objective assessment of metabolic monitoring in patients treated with Seroquel® or Seroquel® XR/quetiapine fumarate: use of IMS Disease Analyzer to... Yes Yes 5238 Finalised EU RMP category 3 A pharmacoepidemiological study to examine patient characteristics, drug utilization pattern and crude incidence rates of selected outcomes in new... No No 5411 Finalised EU RMP category 1 A cohort study to monitor the safety and use of prolonged-release quetiapine (OASIS) No No 5599 Finalised EU RMP category 3 AN OBSERVATIONAL POST-AUTHORIZATION MODIFIED PRESCRIPTION-EVENT MONITORING SAFETY STUDY TO MONITOR THE SAFETY AND UTILIZATION OF EXENATIDE ONCE WEEKLY... Yes Yes 5816 Finalised Not included in RMP Health Outcomes, Resource Use, costs in patients with Stable coronary artery disease a cohort study in the EGB database (HORUS) No No 5905 Ongoing Not included in RMP STUDY ON THE PREVENTION OF CARDIOVASCULAR EVENTS BY ANTIPLATELET AGENTS AFTER ACUTE CORONARY SYNDROME (AReMIS) No No 5987 Finalised Not included in RMP Secondary Prevention of Acute Coronary Events with Antiplatelet Agents: A cohort study in the SNIIRAM database (SPACE-AA) No No 6559 Finalised EU RMP category 3 Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol... No No 8695 Ongoing Unspecified Study Comparing Risk of Hospitalization for Heart Failure Between Dipeptidyl Peptidase-4 Inhibitors and Sulfonylureas Yes No 10229 Ongoing Unspecified Burden of severe uncontrolled eosinophilic asthma in the UK population Yes No 11684 Finalised EU RMP category 3 Comparison of the Risk of Acute Kidney Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic... Yes Yes 11799 Finalised Not included in RMP A non-interventional study of LAIV utilization to identify and characterize medication errors due to expired vaccine use in individuals 2-17 years of... Yes No 12110 Finalised EU RMP category 3 Comparison of the Risk of Acute Liver Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic... Yes Yes 12113 Finalised EU RMP category 3 Comparison of the Risk of Severe Complications of Urinary Tract Infections (UTI) Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and... Yes Yes 12116 Ongoing EU RMP category 3 Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments Yes No 13060 Finalised EU RMP category 3 Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes in the United States No No 13199 Finalised EU RMP category 3 Observational single-cohort data base study of dapagliflozin utilisation in Europe (NA) Yes Yes 13616 Ongoing EU RMP category 1 Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints Yes No 13904 Ongoing EU RMP category 3 Incidence of Thyroid Neoplasm and Pancreatic Cancer in Type 2 Diabetes Mellitus Patients who Initiate Once Weekly Exenatide Compared with Other... Yes No 13956 Finalised EU RMP category 3 Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other... Yes Yes 14852 Finalised EU RMP category 1 Long-Term Post-Marketing Observational Study of the Safety of Roflumilast Yes Yes 15175 Finalised Not included in RMP An observational historical cohort study to evaluate chronic disease onset associated with long-term oral corticosteroid and it’s cost impact on... No No 15277 Finalised Not included in RMP Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during... No No 15400 Finalised Not included in RMP Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during... No No 15869 Planned Not included in RMP Benefits of high dose ICS in patients with asthma and high blood eosinophil counts No No 16875 Finalised Not included in RMP Investigating the possible role of BLood eosinophil counts in guiding ANti-inflammatory treatment of COPD exAcerbations (BLANCA) No No 16891 Finalised Not included in RMP Studying the value of fractional exhaled Nitric Oxide and blood eosinophils as biomarkers in predicting which patients will suffer from more frequent... Yes Yes 17107 Finalised Not included in RMP Health outcomes of patients with acute coronary syndromes prescribed ticagrelor in UK primary care: a retrospective cohort study (Outcomes in UK ACS... Yes Yes 17543 Ongoing Not included in RMP Burden of disease in patients with COPD and high blood eosinophil counts (High eosinophils and COPD) Yes No 17954 Finalised EU RMP category 3 A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK (Acid... Yes No 17960 Finalised EU RMP category 3 A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring (Acid-suppressing Drugs Pregnancy Asthma... Yes No 17989 Finalised Not included in RMP Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study (QUIéTUDE) Yes Yes 18201 Ongoing EU RMP category 3 United States Post-Marketing Observational Cardiovascular Safety Study in Patients taking Naloxegol (Naloxegol US Post-Market Requirement CV Safety) Yes No 18608 Finalised Non-EU RMP-only Specific Clinical Experience Investigation for long-term use of Bydureon subcutaneous injection 2 mg and Bydureon SC Pen 2 mg (PMS Bydureon Long Term... Yes Yes 19606 Finalised Non-EU RMP-only Exenatide (Byetta subcutaneous injection) Specific Clinical Experience Investigation for long-term use (PMS Byetta Long Term Use SCEI) Yes Yes 23651 Finalised Not included in RMP International Severe Asthma Registry (ISAR) Yes No 23769 Planned Not included in RMP Study about the results of the addition of a sulfonylurea, DPP4 inhibitors or SGLT2 inhibitors as a second antidiabetic drug in patients with diabetes... Yes No 25489 Finalised Not included in RMP Demographic and Clinical Characteristics of Severe Asthma Patients Worldwide Yes Yes 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 26310 Ongoing EU RMP category 3 Descriptive Study of the Incidence of Malignancy in Patients with Severe Asthma Overall and Among Those Receiving Benralizumab and Other Therapies, a... Yes No 26461 Ongoing EU RMP category 3 The Benralizumab Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study Yes No 27402 Finalised Not included in RMP Assessment of The High risk and unmEt Need in patients with Coronary Artery Disease and type 2 diabetes in France (ATHENA-F) Yes Yes 28611 Finalised Not included in RMP Hidden Severe Asthma in Primary Care versus ISAR Cohort Yes Yes 29415 Ongoing Not included in RMP Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) No No 30430 Ongoing Not included in RMP Biomarker Relatability in the International Severe Asthma Registry (BRISAR) No No 30943 Ongoing Not included in RMP Longitudinal systemic corticosteroid utilization in the UK, 1990-2018 Yes No 31355 Ongoing Not included in RMP The Characterization and Comparison of Eosinophilic and Non-eosinophilic Phenotypes of Severe Asthma No No 31386 Ongoing Not included in RMP The Impact of Exacerbation Burden on Lung Function Trajectory in a Broad Asthma Population and Severe Asthma Population (Exacerbation and lung... No No 31458 Planned EU RMP category 3 A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients who Initiated Exenatide as Compared with... Yes No 31500 Planned Not included in RMP Eosinophilic asthma phenotypes and associated clinical outcomes No No 32724 Planned Not included in RMP Biologics in severe asthma: utilization patterns, causes for discontinuation and switches No No 33582 Ongoing Not included in RMP Impact of Initiating Biologics In Patients on Long-Term OCS Or Frequent Rescue Steroids (GLITTER) No No 35975 Planned Not included in RMP Burden and consequences of the use of COPD-related systemic corticosteroids (OCS COPD study) No No 36248 Finalised Not included in RMP Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference... Yes Yes 37065 Finalised Not included in RMP An observational cohort study to describe intermittent OCS utilisation and its association with adverse outcomes and healthcare resource use and costs... Yes Yes 37569 Ongoing Not included in RMP Cardiovascular-Renal-Metabolism comorbidity epidemiology and healthcare utilisation – Observational studies across Europe – French part of the study... No No 38128 Finalised Not included in RMP Effectiveness across severe asthma biologic classes (Anti-IL-5 vs Anti IgE) in patients eligible for both (FIRE) Yes No 38288 Finalised Not included in RMP Defining and Characterizing Responders to Biologic Treatment (BEAM) Yes No 38961 Ongoing Not included in RMP Spanish Real World Data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy (S-REAL Study) No No 39096 Ongoing EU RMP category 3 COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) No No 39494 Finalised Not included in RMP Expert opinion on the impact of inhaler choice on climate change and personalised healthcare Yes No 40583 Ongoing Not included in RMP Onset of asthma in severe asthma patients (PATH) No No 41161 Ongoing Not included in RMP Characterisation of the Australian adult population living with asthma: Exacerbation frequency, long-term OCS use and adverse effects. No No 42328 Ongoing EU RMP category 3 Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe A contribution of COVIDRIVE, a public-private partnership to... Yes No 43556 Ongoing EU RMP category 3 A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing... Yes No 43571 Finalised EU RMP category 3 Real-world effectiveness of the Oxford/AstraZeneca COVID-19 vaccine in England. (RAVEN) Yes Yes 43687 Ongoing EU RMP category 3 An Assessment of a relationship between the exposure to COVID-19 vaccines and risk of thrombotic thrombocytopenia syndrome ATTEST study (Association... Yes No 43721 Finalised Not included in RMP Twenty years of COPD primary care: Patterns of management of high-risk COPD and opportunities for optimising care in the United Kingdom 2000-2019:... Yes No 43785 Planned Not included in RMP PhEnotypic Characteristics, coMorBidities and response to thErapeutic inteRventions associated with non-type 2 asthma (EMBER) No No 43806 Finalised Not included in RMP EffectIveness of bioloGics (by classes) in patieNts with dIfferent combination of T2 biomarkErs (IGNITE) Yes Yes 44024 Planned Not included in RMP ImPact of comoRbidity In Severe asthMa patients (PRISM) No No 44027 Planned Not included in RMP CLinical oUtcomes before and after biologic treatMent by bIologic class, by iNdividuAl biologic, and by subgroups of baseliNe characTeristics... No No 45076 Ongoing EU RMP category 3 Medullary Thyroid Carcinoma Surveillance Study: a Case-Series Registry (H9X-MC-B001) Yes No 45972 Ongoing EU RMP category 2 Post-Authorisation Safety Study of Paediatric Patients Initiating Selumetinib: A Multiple-Country Prospective Cohort Study Yes No 49365 Ongoing Not included in RMP Five years of COPD primary care: Patterns of management of high-risk COPD and opportunities for optimising care in Australia 2015-2019 (COPD... No No 49548 Planned Not included in RMP Biologic Usage Patterns, Clinical Outcomes and Healthcare Resource Utilization (CLEAR) No No 49565 Planned EU RMP category 3 A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) During Pregnancy (O-STEREO Study) Yes No 103927 Finalised Non-EU RMP-only Epidemiology of thrombotic thrombocytopenia syndrome in integrated health-care database in England Secondary data analysis using a cohort design... Yes Yes 104132 Planned Not included in RMP Exploring different composite definitions of responders and non-responders to biologic treatment for severe asthma (FULL BEAM) No No 104139 Planned Not included in RMP Impact of biologic initiation on steroid burden and new-onset of potentially OCS-related outcomes in patients with severe asthma (SOLAR) No No 104156 Planned Not included in RMP Real-world use of Breztri/Trixeo for the management of COPD in a UK primary care population Yes Yes 105272 Ongoing Not included in RMP Cardiopulmonary risk model for patients with chronic obstructive pulmonary disease No No 105374 Ongoing Not included in RMP Anti-IL-5/5R versus anti-IL4R switching strategies for uncontrolled severe asthma treated by anti-IL5/5R : A target trial emulation (RAMSES-Switch) No No 105690 Planned EU RMP category 3 A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic... Yes No 106412 Ongoing Not included in RMP An Observational Study to Assess the Real-world Effectiveness and Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against... No No 106900 Ongoing Not included in RMP Evidence in real world for Trixeo® Aerosphere™ Initiation in COPD (ENARXI) No No 106967 Finalised Not included in RMP Patient characteristics, treatment patterns, clinical outcomes, and health care resource utilization in severe asthma subgroups: A retrospective... No No 108728 Planned EU RMP category 3 A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE... Yes No