Links to Studies

Status Official Title Lead Investigator Last Updated
Finalised Comparison of the Risk of Severe Complications of Urinary Tract Infections (UTI) Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments Dr Catherine Johannes 10/11/2021
Finalised Comparison of the Risk of Acute Liver Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments Dr Catherine Johannes 10/11/2021
Finalised Comparison of the Risk of Acute Kidney Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments Dr Catherine Johannes 10/11/2021
Finalised Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments Dr Cristina Rebordosa 23/09/2021
Finalised Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions Mrs Lia Gutierrez 08/09/2021
Finalised Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort Dr Alicia Gilsenan 06/09/2021
Finalised PRECISE/Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium-223 in routine Clinical practIce in SwedEn Professor Pär Stattin 26/07/2021
Finalised Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres Professor Ezgi Gulmez 03/05/2021
Finalised Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up Physician Survey Dr Bayer Clinical Trials BAYER AG 07/04/2021
Finalised Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages Dr Elizabeth B. Andrews 06/04/2021
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 Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury Dr Manel Pladevall 28/01/2021
Finalised Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2) Dr Cristina Rebordosa 26/01/2021
Finalised Post-authorization safety program – validation of the Clinical Practice Research Datalink for the study of cardiovascular and neoplasm events in users of treatments for overactive bladder Dr Alejandro Arana 08/01/2021
Finalised Study on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and postpartum timing of IUD insertion in electronic medical record databases. A postmarketing requirement for Mirena Dr Bayer Clinical Trials Bayer AG 11/11/2020
Finalised Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder Dr John Seeger 28/04/2020
Finalised Evaluation of the Physician Education Component of the Ozurdex Risk Management Plan Dr William K Mountford 14/02/2020
Finalised Drug Utilisation Study for Olodaterol Dr Alicia Gilsenan 21/01/2020
Finalised Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids Dr Alejandro Arana 22/11/2019
Finalised Post-authorization Safety Study Evaluation of Neoplasm Events in Users of Mirabegron and Other Treatments for Overactive Bladder : Core Common Protocol Dr John Seeger 18/11/2019
Finalised Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US Dr James Kaye 30/10/2019
Finalised Agomelatine Drug Utilisation Study in Selected European Countries: A Multinational, Observational Study to Assess Effectiveness of Risk-Minimisation Measures Dr Lynne Hamm 24/07/2019
Finalised Post-authorization Safety Program Using the Swedish National Registers—A Validation Study of Cardiovascular and Neoplasm Events in Users of Pharmacological Treatments for Overactive Bladder Dr Alejandro Arana 10/04/2019
Finalised 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 Dr Alejandro Arana 10/04/2019
Finalised Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study Dr Elizabeth Andrews 18/02/2019
Finalised Assessing the Incidence of Osteosarcoma Among Teriparatide Users Using Medicare Part D and State Cancer Registry Data Dr Nicole Kellier-Steele 20/12/2018
Finalised Evaluation of potential off-label use of dabigatran etexilate in Europe Dr Manel Pladevall-Vila 20/09/2018
Finalised Cilostazol Drug Utilisation Study Dr Jordi Castellsague 25/07/2018
Finalised Post-authorisation Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide Dr Alejandro Arana 05/06/2018
Finalised Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids Dr Jordi Castellsague 15/05/2018
Finalised Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study Dr Elizabeth Andrews 14/03/2018
Finalised Safety Evaluation of Adverse Reactions in Diabetes - Comparative studies Professor Miriam Sturkenboom 25/08/2017
Finalised Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies Professor Miriam Sturkenboom 25/08/2017
Finalised Forteo/Forsteo post-approval osteosarcoma surveillance study Dr Elizabeth Andrews 15/08/2017
Finalised Evaluation of the Use of Nepafenac in Selected European Populations Dr Alejandro Arana Navarro 25/07/2017
Finalised Post-market clinical follow-up study – Retrospective evaluation of endothelial cell density and IOL explants related to the clinical use of AcrySof® CACHET® Phakic Lens in three European countries Dr Alejandro Arana 22/07/2016
Finalised Risk of Upper Gastrointestinal Complications in Users of Nonsteroidal Anti-inflammatory Drugs Dr Susana Perez-Gutthann 05/11/2013
Ongoing 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 Dr Cristina Rebordosa 05/11/2021
Ongoing Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine Dr Heather Rubino 06/10/2021
Ongoing Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints Dr Cristina Rebordosa 02/08/2021
Ongoing ACCESS template protocol for safety of COVID-19 vaccines Professor Miriam Sturkenboom 19/02/2021
Ongoing Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study Dr Alejandro Arana 15/02/2021
Ongoing Extrapyramidal symptoms in patients treated with Abilify Maintena®: Cohort study with a 2-year follow-up using European automated healthcare databases Dr Non-interventional Research Manager H. Lundbeck A/S 01/09/2020
Ongoing An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers Dr Elena Rivero 07/07/2020
Ongoing A Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry Dr Joan Fortuny 18/06/2020
Ongoing Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments Ms Lia Gutierrez 03/07/2017
Planned A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing secondary health data sources (COVID-19) Dr Cristina Rebordosa 23/11/2021
Planned An Observational Post-Authorisation Safety Study of Lesinurad Patients Dr Elena Rivero 22/11/2021
Planned Postmarketing Noninterventional Study Evaluating the Risk of Endometrial Cancer in Women Who Have Been Prescribed Imvexxy® Dr Andrea Margulis 04/10/2021
Planned Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability Dr Susana Perez-Gutthann 20/09/2021
Planned Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources Professor Miriam Sturkenboom 26/08/2021
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 Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis Dr Andrea Margulis 20/03/2021
Planned CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study Professor Hedvig Nordeng 10/02/2021