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 2569 Ongoing EU RMP category 3 The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (Gilenya Pregnancy Registry) Yes No 3247 Finalised Non-EU RMP-only An international disease registry collecting data on manifestations, interventions and outcomes in patients with tuberous sclerosis complex - TOSCA Yes Yes 3296 Finalised EU RMP category 3 A Non Interventional Long term safety Study of Ruxolitinib in Myelofibrosis (JAKAVI) Yes Yes 3335 Finalised Not included in RMP A PROSPECTIVE NON-INTERVENTIONAL SAFETY STUDY IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA RECEIVING NILOTINIB IN DAILY PRACTICE ACCORDING TO UPDATED... Yes Yes 3577 Finalised EU RMP category 3 A Cohort Study to Assess Various Safety Outcomes of Interest in Users of Aliskiren Using Claims Data Yes Yes 4101 Finalised EU RMP category 3 Post-licensure observational safety study of specific outcomes after Optaflu vaccination among adults in The Health Improvement Network (THIN)... Yes Yes 4207 Finalised Not included in RMP Outpatient care with long-acting bronchodilators: COPD Register in Germany (DACCORD) Yes Yes 4568 Finalised EU RMP category 3 Assessing the Incidence of Ischemic Colitis in Treated Adult Hypertensive Patients in the United States – a Descriptive, Retrospective Cohort Study... Yes Yes 4845 Finalised EU RMP category 3 Multinational, multi-database drug utilization study of inhaled NVA237 in Europe (NVA237 DUS) Yes Yes 4963 Finalised EU RMP category 3 Angioedema among patients with hypertension treated with aliskiren or other anti-hypertensive medications in the US – a cohort Study and a nested... Yes Yes 5035 Finalised EU RMP category 1 Multinational, multi-database cohort study to assess adverse cardiovascular and cerebrovascular outcomes and mortality in association with inhaled... Yes Yes 5153 Finalised EU RMP category 3 An Open-Label, Multi-Centre, Non-Interventional, Post-Marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Votrient Administered in... Yes Yes 5914 Ongoing EU RMP category 1 An observational, multicenter study to evaluate the safety and tolerability of deferasirox in the treatment of pediatric patients with... No No 6073 Finalised EU RMP category 3 Program to evaluate the Tasigna (nilotinib) educational materials: survey to patients and physicians in five EU countries Yes Yes 6239 Finalised EU RMP category 3 PRINCIPAL: A prospective observational study of real world treatment patterns and treatment outcomes in patients with advanced or metastatic renal... Yes Yes 6338 Finalised Not included in RMP Aliskiren Prescription Event Monitoring Study (Aliskiren PEM) No No 6665 Finalised EU RMP category 1 A European observational registry collecting efficacy and safety data in newly diagnosed pediatric Philadelphia-positive (Ph+) Acute Lymphoblastic... Yes Yes 7201 Finalised EU RMP category 3 WEUSKOP7136: A global, prospective cohort study to evaluate the real-world use of eltrombopag in adult patients with chronic Hepatitis C Virus... Yes Yes 7309 Finalised EU RMP category 3 WEUSKOP7135: A prospective, observational cohort study nested within the HCV TARGET study to evaluate real-world use (201110) Yes Yes 7317 Finalised EU RMP category 3 Reporting and Analysis Plan - Evaluation of Secondary Malignancies in Patients Treated with Dabrafenib in Randomized, Controlled Trials (201710) Yes Yes 7325 Finalised Not included in RMP Observational prospective study in post-menopausal women with advanced HR+/HER2- breast cancer treated with a combination of Afinitor® + exemestane to... Yes Yes 7537 Finalised EU RMP category 3 A drug utilisation study in patients treated with EXELON®/PROMETAX® (rivastigmine) transdermal patch Yes Yes 7607 Ongoing Unspecified Spanish Registry of Systemic Treatments in Psoriasis (Biobadaderm) Yes No 7674 Finalised EU RMP category 1 Multinational database cohort study to assess RMP specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe Yes Yes 7795 Finalised EU RMP category 3 Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe Yes Yes 7828 Finalised EU RMP category 3 Incidence of colorectal hyperplasia and gastrointestinal cancer in treated adult hypertensive patients in the United States – a cohort study based on... Yes Yes 8295 Finalised EU RMP category 3 A multi-database cohort study to assess the incidence rates of colorectal hyperplasia among hypertensive patients Yes Yes 8816 Finalised Not included in RMP A 36 month observational study to describe the long-term efficacy and safety of ranibizumab 0.5 mg treatment in patients with visual impairment due to... Yes Yes 9073 Planned Unspecified Severe Gout Registry (SGR) No No 9076 Finalised Non-EU RMP-only A phase IV multicentre, open-label, non-interventional study of postmenopausal women with oestrogen receptor positive locally advanced or metastatic... Yes Yes 9462 Finalised Not included in RMP Breast Cancer Treatment with Afinitor® (Everolimus) and Exemestane for HR+ Women (BRAWO) Yes Yes 10093 Finalised Non-EU RMP-only Drug Use Investigation for Arzerra Chronic Lymphocytic Leukemia (CLL) (116789) Yes Yes 10165 Planned Unspecified Predictors of treatment choice in patients with COPD Yes No 10541 Ongoing EU RMP category 3 The Mycophenolate Pregnancy Registry Yes No 10649 Finalised Not included in RMP Usage Patterns of Selected Systemic NSAIDs (Including Diclofenac): A Retrospective Cohort Study Yes Yes 10715 Finalised Not included in RMP PROSPECT: Observational, descriptive study of PRior and concomitant psoriasis treatments in patients receiving Secukinumab in the routine treatment of... Yes Yes 10753 Finalised Not included in RMP Real life assessment of chronic obstructive pulmonary disease Inhaler devices handling (INHALER) No No 11656 Finalised Not included in RMP Validation of the Concept of COPD Control in Clinical Practice Yes No 12183 Finalised EU RMP category 3 Bexsero® pregnancy registry: an observational study of the safety of Bexsero® exposure in pregnant women and their offspring Yes Yes 12912 Finalised Not included in RMP Assessing the profile of CHF patients with redUced ejection fraction being managed in the pRimary care sectOr across GeRmany as well as the... No No 12987 Finalised Not included in RMP Evaluation of the undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease No No 13054 Finalised EU RMP category 3 EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a... Yes Yes 13218 Finalised Not included in RMP Historical matched-cohort study assessing whether the use of inhaled corticosteroids shortens time to first diagnosis or accelerates the progression... Yes No 13835 Finalised Not included in RMP Assessment of Real LIfe cAre – Describing EuropeaN Heart FailurE Management (ARIADNE) Yes Yes 13908 Finalised Not included in RMP ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and... Yes Yes 18214 Ongoing EU RMP category 3 Non-interventional post-authorization multi-database safety study to characterize the risk of angioedema and other specific safety events of interest... Yes No 18261 Finalised EU RMP category 3 Panobinostat Post Authorization Safety Study, a non-interventional study of panobinostat in combination with bortezomib and dexamethasone in patients... Yes Yes 18358 Ongoing EU RMP category 3 Non-interventional post-authorization multi-database safety study to assess the risk of myotoxicity, hepatotoxicity and acute pancreatitis in... Yes No 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 28059 Finalised Not included in RMP Retrospective analysis of safety in elderly metastatic or unresectable BRAF V600 melanoma patients treated with Tafinlar (dabrafenib) plus Mekinist... Yes Yes 31153 Ongoing EU RMP category 1 A Post-Authorization, Multicenter, Multinational, Longitudinal, Observational Safety Registry Study for Patients Treated with Voretigene Neparvovec Yes No 31405 Planned Not included in RMP A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator+add-on+app) on time to treatment... No No 32497 Ongoing EU RMP category 1 Registry study to assess the long-term safety of patients with B lymphocyte malignancies treated with tisagenlecleucel Yes No 36014 Planned EU RMP category 3 A non-interventional study to examine patient characteristics and drug utilization patterns in migraine patients treated with prophylactic drugs in... Yes No 38736 Planned EU RMP category 3 INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden Yes No 39412 Ongoing EU RMP category 3 Adakveo (crizanlizumab) PRegnancy outcomes Intensive Monitoring (PRIM) (Adakveo (crizanlizumab) PRIM) Yes No 41010 Planned EU RMP category 3 Alpelisib (Piqray®) Post-Authorization Safety Study (PASS): a non-interventional study of alpelisib in combination with fulvestrant in postmenopausal... Yes No 41014 Finalised Not included in RMP Retrospective analysis of imaging and clinical features from patients treated with brolucizumab in post-marketing setting with reports of intraocular... Yes Yes 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 41495 Planned Non-EU RMP-only Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated with Mayzent (siponimod): An OTIS Observational Pregnancy... Yes No 42022 Ongoing EU RMP category 3 Survey among healthcare professionals treating patients with metastatic breast cancer in selected European countries to evaluate their knowledge on... Yes No 42905 Ongoing EU RMP category 3 Monitoring of pregnancy outcomes in women treated with inclisiran: a non-interventional study Yes No 44782 Ongoing EU RMP category 3 Survey among healthcare professionals (neurologists treating patients with MS along with MS specialist nurses) and patients in selected European... Yes No 45799 Finalised Not included in RMP Risk of Hypertension, Acute Myocardial Infarction, and Stroke in Migraine Patients Treated With Migraine Preventive Medications (20200403) Yes Yes 45875 Ongoing EU RMP category 3 Evaluation of pregnancy and infant outcomes in Mayzent patients using PRegnancy outcomes Intensive Monitoring (PRIM) data – The Mayzent-PRIM study Yes No 49803 Planned Not included in RMP Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated with Kesimpta (ofatumumab) using OTIS... Yes No 49855 Ongoing EU RMP category 3 Evaluation of pregnancy and infant outcomes in Kesimpta patients using PRegnancy outcomes Intensive Monitoring (PRIM) data - The Kesimpta-PRIM study.... Yes No 104255 Planned EU RMP category 3 Kesimpta long-term retrospective safety study utilizing real- world data from existing multiple sclerosis registries and databases from multiple... Yes No 104950 Planned EU RMP category 3 Survey to assess physicians' knowledge of Exjade posology and biological monitoring recommendations as described in the Educational Materials Yes 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 106133 Planned Not included in RMP Kesimpta (ofatumumab) pregnancy and infant safety study using real world data Yes No