| Status |
Official Title |
Lead Investigator |
Last Updated |
| Finalised |
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 |
06/11/2023 |
| Finalised |
Drug utilisation study of Radium 223 under routine clinical practice in Europe |
Dr Bayer Clinical Trials BAYER AG |
27/10/2023 |
| Finalised |
A Post-Authorization Safety Study of Golimumab in Ulcerative Colitis Using the Spanish ENEIDA Registry |
Dr Joan Fortuny |
10/10/2023 |
| Finalised |
Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources |
Professor Miriam Sturkenboom |
31/08/2023 |
| Finalised |
Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen |
Dr Elisa Martín Merino |
24/04/2023 |
| Finalised |
TAK-771-4002: Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
Dr Study contact Takeda |
20/04/2023 |
| 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 |
11/01/2023 |
| 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 |
11/01/2023 |
| 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 |
11/01/2023 |
| Finalised |
ACCESS template protocol for safety of COVID-19 vaccines |
Professor Miriam Sturkenboom |
09/01/2023 |
| Finalised |
Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability |
Dr Susana Perez-Gutthann |
18/10/2022 |
| Finalised |
Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists |
Dr Cristina Rebordosa |
19/09/2022 |
| Finalised |
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids |
Dr Jordi Castellsague |
24/03/2022 |
| Finalised |
 Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids |
Dr Alejandro Arana |
24/03/2022 |
| 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 |
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 |
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 |
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 |
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 |
15/09/2023 |
| Ongoing |
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints |
Dr Cristina Rebordosa |
07/08/2023 |
| Ongoing |
Retrospective Cohort Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy |
Dr Elena Rivero |
11/07/2023 |
| Ongoing |
An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States |
Dr Kevin Haynes |
03/07/2023 |
| Ongoing |
FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes |
Dr Catherine Johannes |
15/06/2023 |
| Ongoing |
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 |
12/05/2023 |
| Ongoing |
An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19) |
Dr Fariba Ahmadizar |
08/05/2023 |
| Ongoing |
Risk of Mortality Associated With Pimavanserin Use Compared With Other Atypical Antipsychotics in Patients With Parkinson’s Disease–Related Psychosis |
Dr Bradley Layton |
20/12/2022 |
| Ongoing |
Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study |
Dr Alejandro Arana |
24/11/2022 |
| Ongoing |
CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study |
Professor Hedvig Nordeng |
16/08/2022 |
| 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 |
| Planned |
Cross-sectional Study Evaluating the Effectiveness of Venetoclax Risk-Minimisation Measures Among Haematologists in Europe |
Mr Daniel Wolin |
14/07/2023 |
| Planned |
Cross-sectional Study Evaluating the Effectiveness of the Venetoclax Patient Card Among Adult Patients in Europe |
Mr Daniel Wolin |
14/07/2023 |
| Planned |
Post-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data |
Dr Elena Rivero |
15/05/2023 |
| Planned |
Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis |
Dr Andrea Margulis |
11/04/2023 |
| Planned |
Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International)) |
Professor Miriam Sturkenboom |
29/09/2022 |
| 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 |
