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Studies
List of studies that have been conducted using the data source
- Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of the impact of design/database/population differences on the outcome of the studied association
- Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.
- Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design
- CAncer Risk and INsulin analoGues (CARING) project
- Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources.
- Assessment of Utilisation of Pioglitazone in Denmark Post Label Change (July 2011)
- Estimation of Off-Label Use of XGEVA® (denosumab) Using Population-Based Databases in Denmark (20101335)
- ADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children
- European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance
- Multinational Observational Database Study on Imminent Osteoporotic Fracture Risk: Stage 1 (IFRISK)
- A multinational active safety surveillance study of crizotinib in Europe and the United States
- An observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated with etanercept or other biologics using merged data from Sweden, Denmark and Finland
- Exposure and coverage to routine schedule vaccines in different EU countries (ADVANCE-POC2)
- Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study
- Estimating prevalence and incidence of acute myocardial infarction in a set of heterogeneous sources of observational health data collaborating in the EMIF Platform
- The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources
- Post-Authorization Safety Program—Validation of the Danish Data Resources for the Study of Cardiovascular and Neoplasm Events in Users of Treatments for Overactive Bladder
- Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark
- Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common Protocol
- Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark, Norway, Sweden))
- Drug Utilisation Study for Olodaterol
- Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends
- Use of non-steroidal anti-inflammatory drugs and clinical outcome of COVID-19: a Danish nationwide cohort study (NSAID COVID-19)
- Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder
- A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes
- Survey on the collection of data on adverse events related to medicinal products through registries
- European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality for romosozumab by the EU-ADR Alliance
- EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO ADHERENCE TO THE RISK MINIMIZATION MEASURES FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE
- EUROPEAN NON-INTERVENTIONAL POST AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU ADR ALLIANCE
- Drug-drug interactions between dicloxacillin/flucloxacillin and DOACs
- Multinational, multi-database cohort study to assess adverse cardiovascular and cerebrovascular outcomes and mortality in association with inhaled NVA237 in Europe (NVA237 PASS)
- Multinational, multi-database drug utilization study of inhaled NVA237 in Europe (NVA237 DUS)
- Incidence and Prevalence of Interstitial Lung Disease and their progressive fibrosing phenotypes in 6 European Countries (PERSEIDS)
- Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study (ACE-I/ARB and COVID-19)
- Impact of EU label changes for hydroxyzine products: post-referral prescribing trends
- Inhaled corticosteroids and COVID-19 morbidity: Nationwide cohort study
- The effect of mental disorders and treatment with psychotropic agents on the course of COVID-19 (COVID-19 psychotropics)
- Risk and course of COVID-19 infection in patients with hypo- or hyperthyroidism. A Danish population-based cohort study (Thyroid dysfunction and COVID-19 infection)
- Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis (MELODIC Study)
- Impact of use of newer glucose lowering drugs on outcomes in patients with COVID-19
- Impact of risk minimisation in patients treated with rosiglitazone-containing products
- Metformin use in renal impairment
- Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens
- Study of utilisation of combined hormonal contraceptives in Europe
- Effectiveness and safety of non-vitamin K anticoagulants (NOACs) versus warfarin in frail patients with nonvalvular atrial fibrillation (AF): a nationwide cohort study
- Impact of use of proton pump inhibitors on susceptibility to infection and risk of hospitalisation in patients with COVID-19
- Dynamics of prescription drug use, diagnoses and health care utilization after community managed SARS-CoV-2 infection
- The prognosis of coronavirus disease (COVID-19) in patients recently treated with immunosuppressant medications.
- A Retrospective Cohort Study to Assess the Safety of Baricitinib Compared with Other Therapies Used in the Treatment of Rheumatoid Arthritis in Nordic Countries (I4V-MC-B011)
- Treatment patterns and outcomes of Crohn’s disease and ulcerative colitis patients initiated with biologic therapies in Denmark (IBDBIODK)
- Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions
- Drug utilization study of dexamfetamine in European countries (DUS of dexamfetamine)
- Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments
- The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases
- Prospective Cohort Study of Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients in Europe (OBS12573)
- Use of Low-dose Quetiapine and the Risk of Major Adverse Cardiovascular Events
- A national register based study examining the prevalence, comorbidities, healthcare resource utilisation and burden of illness of hereditary hypophosphatemia in Demark
- Drug utilization study for Elvanse® / Tyvense® / Elvanse® Adult in Europe
- Cardiovascular and renal outcomes, and mortality in Danish patients with type 2 diabetes who initiate empagliflozin versus GLP1-RA: A Danish nationwide comparative effectiveness study (EMPLACE)
- Hip fracture information profiling, surveillance and treatment across epidemiological registries (HIPSTAR)
- Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19)
- Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19)
- Real-world evidence for non-valvular atrial fibrillation patients treated with oral anticoagulation in the Nordics (REATTAIN)
- Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU
- Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT)
- A post-authorisation safety study (PASS) to evaluate the long-term cardiovascular and psychiatric safety profile of methylphenidate (MPH) in adult patients with attention deficit/hyperactivity disorder (ADHD) in European Countries (PASS on methylphenidate in adults)
- A post-authorisation, non-interventional, retrospective, drug-utilisation study to describe the pattern of use of lenalidomide in patients with myelodysplastic syndromes (MDS) (CC-5013-MDS-012)
- Post-authorisation safety study of NOCDURNA for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria: A multi-country cohort study using secondary data. (NOCDURNA PASS)
- A post-marketing registry-based prospective cohort study of long-term safety of risankizumab in Denmark and Sweden
- Drug Utilisation Study of Intuniv® (guanfacine extended release) in European Countries, Study protocol I: Database study (Intuniv data base study Europe)
- CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study
- Non-interventional post-authorization multi-database safety study to characterize the risk of angioedema and other specific safety events of interest in association with use of Entresto® (sacubitril/valsartan) in adult patients with heart failure
- Non-interventional post-authorization multi-database safety study to assess the risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan (Entresto®)
- Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists
- A non-interventional register-based comparative effectiveness study of rhFSH-alfa reference product vs. highly purified human menopausal gonadotropin or rhFSH-alfa biosimilar products for ovarian stimulation in in vitro fertilization or intracytoplasmic sperm injection treatment in Denmark and Sweden – The Nordic Follitropin Alfa Comparative Effectiveness Study (NORD-FACE)
- NN9535-4447 Epidemiological assessment of the risk for pancreatic cancer associated with the use of semaglutide in patients with type 2 diabetes- A cohort study based on Nordic registry data
- Establish an EU catalogue of sources of real-world data, characterised by a common set of metadata and data quality measurements
- Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)
- Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends
- Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends
- A Population-based Study of the Safety of Gabapentin Use During Pregnancy
- Association between COVID-19 vaccines and paediatric safety outcomes in children and adolescents aged 5-19 years in the Nordic countries: Myocarditis, pericarditis and thromboembolic events
- VAG-4602: Vaginal estradiol tablets (Vagifem®) and endometrial cancer risk in the treatment of postmenopausal vaginal atrophy: A register-based cohort study in postmenopausal women
- Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)
- A Non-interventional Observational Longitudinal Post-Authorization Safety Study (PASS) of SIMPONI® in Treatment of Ulcerative Colitis using Nordic National Health Registries (MK-8259-013)
- Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors (PASS renal, liver injury, infection, ketoacidosis)
- DRUG UTILISATION AND SAFETY STUDY OF MYSIMBA/CONTRAVE IN EUROPE AND THE UNITED STATES (NB-451 DUS)
- Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries
- mRNA-1273-P910: Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2.
- Use cases for development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle (Real4Reg)
- Characterization of neurodevelopmental disorders in children exposed in utero to valproate and/or other antiepileptic drugs with long-term follow-up: retrospective study of multiple European data sources (AVALON)
- Kesimpta (ofatumumab) pregnancy and infant safety study using real world data
- Cohort Study of Long-term Safety of Upadacitinib in the Treatment of Atopic Dermatitis in Denmark and Sweden
- Exposure to ACEi, ARB and statin drugs among women of child-bearing age in Denmark
- A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab (SIMA PASS)
- Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe
- EHDS2 Pilot Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 during the Omicron period.
- Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe
- A Non-Interventional Multi-Database Post-Authorisation Study to Assess PregnancyRelated Safety Data from Women with SLE Exposed to Anifrolumab (ROSE PASS)
- Monitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products
- Long-term real-world safety of ozanimod – A post-authorisation safety study (PASS) in patients diagnosed with ulcerative colitis
- Comparative Cohort Study of Long-term Safety Outcomes of Risankizumab Compared to Biologic Treatments for Crohn’s Disease in a Real-world Setting in Sweden and Denmark
- Drug Utilization Study Evaluating Additional Risk Minimization Measures for Upadacitinib in the Treatment of Atopic Dermatitis in Europe
- An Active Surveillance Study to Monitor the Safety of Abrocitinib Among Real-World Patients with Atopic Dermatitis (AD) in the European Union (EU)
- Postauthorisation Safety Study (PASS) of Avatrombopag and Haematological Malignancies in Patients With Primary Immune Thrombocytopaenia
- A Drug Utilization Study to Evaluate the Effectiveness of Risk Minimization Measures (RMMs) for Abrocitinib in the EU Using Electronic Healthcare Data (B7451085)