Links to Data sources

Sr. No Display Name Type Country Last Updated
1 Danish Registries (access/analysis) Data Source Denmark 20/07/2021

Links to Studies

Status Official Title Lead Investigator Last Updated
Finalised Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions Mrs Lia Gutierrez 08/09/2021
Finalised Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines Professor Miriam Sturkenboom 26/08/2021
Finalised Study of utilisation of combined hormonal contraceptives in Europe Professor Henrik Toft Sørensen 03/05/2021
Finalised Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens Professor Henrik Toft Sørensen 03/05/2021
Finalised Metformin use in renal impairment Professor Henrik Toft Sørensen 03/05/2021
Finalised Impact of risk minimisation in patients treated with rosiglitazone-containing products Professor Henrik Toft Sørensen 03/05/2021
Finalised Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe Ms Novartis Clinical Disclosure Officer 22/02/2021
Finalised Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists Dr Cristina Rebordosa 29/01/2021
Finalised Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study Professor Henrik Toft Sørensen 10/12/2020
Finalised Multinational, multi-database cohort study to assess adverse cardiovascular and cerebrovascular outcomes and mortality in association with inhaled NVA237 in Europe Ms Clinical Disclosure Officer Novartis 18/11/2020
Finalised Multinational database cohort study to assess RMP-specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe Ms Clinical Disclosure Officer Novartis 23/09/2020
Finalised A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes Professor Vera Ehrenstein 25/08/2020
Finalised Drug Utilisation Study for Olodaterol Dr Alicia Gilsenan 21/01/2020
Finalised Beyond Pooled –Part of the BEYOND study program (BEnefit of NOACs studY of nOn-valvular AF patieNts in NorDic countries) Professor Vera Ehrenstein 16/01/2020
Finalised Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark Dr Vera Ehrenstein 19/07/2019
Finalised Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) Dr Patrick Blin 01/04/2019
Finalised Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism Professor Henrik Toft Sørensen 19/11/2018
Finalised A multinational active safety surveillance study of crizotinib in Europe Professor Henrik Toft Sørensen 18/07/2018
Finalised European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance Dr Daniel Prieto-Alhambra 22/03/2018
Finalised Monitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products Professor Henrik Toft Sørensen 15/12/2016
Ongoing CharacTeristics of treAtment response to hIgh dose ICS/LABA vs. Medium or high dOse ICS/LABA + LAMA in patients with uncontRolled moderate to severe asthma on medium dose ICS/LABA - TAILOR study Dr Katia Verhamme 19/11/2021
Ongoing 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 Ms Novartis Clinical Disclosure Officer 05/05/2021
Ongoing 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®) Ms Novartis Clinical Disclosure Office 05/05/2021
Ongoing 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 Professor Henrik Toft Sørensen 03/05/2021
Ongoing ACCESS template protocol for safety of COVID-19 vaccines Professor Miriam Sturkenboom 19/02/2021
Ongoing EUROPEAN NON-INTERVENTIONAL POST AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU ADR ALLIANCE Dr Clinical Trial Registries and Results Personal data of lead investigator will not be disclosed because his/her consent required for disclosure according to applicable data protection laws is not available. 29/10/2020
Ongoing EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO ADHERENCE TO THE RISK MINIMIZATION MEASURES FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE Dr Clinical Trial Registries and Results Personal data of lead investigator will not be disclosed because his/her consent required for disclosure according to applicable data protection laws is not available. 29/10/2020
Ongoing 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 Dr Clinical Trial Registries and Results Personal data of lead investigator will not be disclosed because his/her consent required for disclosure according to applicable data protection laws is not available. 29/10/2020
Planned Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19) Professor Henrik Toft Sørensen 29/11/2021
Planned Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19) Professor Henrik Toft Sørensen 25/11/2021
Planned Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International)) Professor Miriam Sturkenboom 26/08/2021
Planned Drug utilisation study of Radium 223 under routine clinical practice in Europe Dr Bayer Clinical Trials BAYER AG 16/08/2021
Planned A non-interventional study to examine patient characteristics Ms Novartis Clinical Disclosure Officer 05/05/2021
Planned Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis Dr Andrea Margulis 20/03/2021
Planned A Population-based Study of the Safety of Gabapentin Use During Pregnancy Dr Asomaning Kofi 11/12/2020
Planned Exposure and coverage to routine schedule vaccines in different EU countries Professor Miriam Sturkenboom 02/02/2019