| Status |
Official Title |
Lead Investigator |
Last Updated |
| 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 |
08/12/2020 |
| Finalised |
Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists |
Dr Cristina Rebordosa |
19/11/2020 |
| 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 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 |
10/11/2020 |
| Finalised |
 Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions |
Mrs Lia Gutierrez |
06/11/2020 |
| 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 |
Cohort Study of the Relative Incidence of Major Cardiovascular Events Among Patients Initiating Prucalopride Versus a Matched Comparator Cohort |
Dr Alicia Gilsenan |
10/08/2019 |
| 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-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury |
Dr Manel Pladevall |
07/05/2019 |
| 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 |
Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres |
Professor Ezgi Gulmez |
31/08/2017 |
| 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 |
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints |
Dr Cristina Rebordosa |
08/12/2020 |
| Ongoing |
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 |
27/10/2020 |
| 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 |
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 |
29/07/2020 |
| 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 |
Post-authorisation safety study (PASS) to evaluate risk minimisation measures for medication errors with Uptravi during the titration phase in patients with pulmonary arterial hypertension (PAH) in clinical practice |
Dr Mary Anthony |
08/06/2020 |
| 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 |
03/06/2020 |
| Ongoing |
Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages |
Dr Elizabeth B. Andrews |
13/04/2020 |
| Ongoing |
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 |
18/03/2020 |
| Ongoing |
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 |
18/03/2020 |
| Ongoing |
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 |
18/03/2020 |
| Ongoing |
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 |
31/12/2019 |
| 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 |
Drug utilisation study of Radium 223 under routine clinical practice in Europe |
Dr Bayer Clinical Trials BAYER AG |
13/10/2020 |
| Planned |
Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study |
Dr Arana Alejandro |
29/07/2020 |
| Planned |
Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis |
Dr Margulis Andrea |
05/03/2020 |
| Planned |
An Observational Post-Authorisation Safety Study of Lesinurad Patients |
Dr Elena Rivero |
05/07/2019 |
