| Status |
Official Title |
Lead Investigator |
Last Updated |
| Finalised |
Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing trends |
Professor Deborah Layton |
30/10/2020 |
| Finalised |
Hydroxychloroquine safety and potential efficacy as an antiviral prophylaxis in light of potential wide-spread use in COVID-19: a multinational, large-scale network cohort and self-controlled case series study |
Professor Daniel Prieto-Alhambra |
06/07/2020 |
| Finalised |
Linaclotide Utilisation Study in Selected European Populations |
Dr Javier Cid |
11/03/2020 |
| Finalised |
Post-Authorisation Safety Study of Agomelatine and the Risk of Hospitalisation for Acute Liver Injury |
Dr Manel Pladevall |
07/05/2019 |
| Finalised |
Drug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland |
Dr Ron Herings |
02/05/2019 |
| Finalised |
Apixaban drug utilization study in Stroke prevention in atrial fibrillation (SPAF) |
Dr Morros Pedrós Rosa |
14/02/2019 |
| Finalised |
Multinational, multi-database drug utilization study of indacaterol/glycopyrronium bromide in Europe |
Ms Novartis Clinical Disclosure Officer |
17/09/2018 |
| Finalised |
Cilostazol Drug Utilisation Study |
Dr Jordi Castellsague |
25/07/2018 |
| Finalised |
European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance |
Dr Daniel Prieto-Alhambra |
22/03/2018 |
| Finalised |
Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children |
Professor Miriam Sturkenboom |
27/11/2017 |
| Finalised |
ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and whole-cell pertussis-containing vaccines in preschool children |
Dr Hanne-Dorthe Emborg |
24/11/2017 |
| Finalised |
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 |
Dr Daniel Weibel |
22/11/2017 |
| Finalised |
: Measurement of the effectiveness of statins in vAscular morbidity and mortality Reduction in the population without history of vascular disease but with intermediate risk and ankle-brachial Index < 0.9 in primAry care setting |
Dr Rafel Ramos |
06/06/2013 |
| Finalised |
Cost-Effectiveness Analysis of Treatment with Statins in Primary Prevention of Vascular Events. |
Ms Maria Garcia |
06/06/2013 |
| Ongoing |
Linaclotide Safety Study for the Assessment of Diarrhoea—Complications and Associated Risk Factors in Selected European Populations with IBS-C |
Dr Javier Cid |
08/12/2020 |
| Ongoing |
VALIDATION STUDY PROTOCOL (OP0007) FOR THE 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 (OP0004) AND EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE (OP0006) |
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 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 |
| Ongoing |
Assessing exposure to cardiovascular therapy, anxiety depressive syndrome treatment and anti-infectives during pregnancy and breastfeeding |
Dr Ainhoa Gomez-Lumbreras |
20/10/2020 |
| Ongoing |
Sociodemographic, clinical and pharmacological characteristics associated with the prognosis of patients with SARS-CoV-2 infection (Características sociodemográficas, clínicas y farmacológicas asociadas con el pronóstico en pacientes con infección por SARS-CoV-2) |
Dr Morros Pedrós Rosa |
15/09/2020 |
| Ongoing |
RANITIDINE AND OTHER HISTAMINE-H2-RECEPTOR ANTAGONISTS – A DRUG UTILISATION STUDY |
Dr Katia Verhamme |
03/02/2020 |
| Ongoing |
The comparative safety of first-line conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) used for the treatment of rheumatoid arthritis: protocol for a multi-database real-world cohort study |
Professor Daniel Prieto-Alhambra |
30/01/2020 |
| Ongoing |
Utilisation disease-modifying anti-rheumatic drugs (DMARDs) used for the treatment of rheumatoid arthritis: protocol for a multi-database real-world cohort study |
Professor Prieto Dani |
24/01/2020 |
| Ongoing |
USE OF PSYCHOTROPIC DRUGS IN CHILDREN AND ADOLESCENTS IN CATALONIA. A cohort study with real world data from the electronic primary health care record from 2007-2017. |
Dr Gomez-Lumbreras Ainhoa |
26/02/2019 |
| Ongoing |
Estimating prevalence and incidence of acute myocardial infarction in a set of heterogeneous sources of observational health data collaborating in the EMIF Platform |
Dr Roberto Giuseppe |
14/02/2019 |
| Ongoing |
 Risk of lactic acidosis associated with metformin use in patients with type 2 diabetes and moderate-severe chronic kidney disease: a case-control study |
Dr Consuelo Pedrós |
13/12/2018 |
| Ongoing |
Impact of medication adherence on mortality and cardiovascular morbidity: a population-based retrospective cohort study. IMPACT study |
Dr Giner-Soriano Maria |
09/10/2018 |
| 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 |
11/12/2017 |
| 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 |
11/12/2017 |
| Ongoing |
Riesgo de accidente vascular cerebral asociado al uso de medicamentos: estudio de casos y controles |
Dr Maria Angeles Quijada Manuitt |
01/04/2016 |
| Ongoing |
Riesgo de cáncer colorrectal asociado al uso de medicamentos: estudio de casos y controles |
Dr Maria Angeles Quijada Manuitt |
08/03/2016 |
| Ongoing |
Effectiveness of an Interventional to Improve the Adequacy of the Indication of Lipid Lowering Treatment in Primary Prevention: Randomized Clinical Trial |
Dr Bonaventura Bolíbar |
12/02/2014 |
| Planned |
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines |
Dr Caitlin Dodd |
22/09/2020 |
| Planned |
Comparative safety study of tramadol and codeine users: a population-based cohort study |
Dr Reyes Carlen |
08/08/2020 |
| Planned |
An Observational Post-Authorisation Safety Study of Lesinurad Patients |
Dr Elena Rivero |
05/07/2019 |
| Planned |
Exposure and coverage to routine schedule vaccines in different EU countries |
Professor Miriam Sturkenboom |
02/02/2019 |
| Planned |
Study about the results of the addition of a sulfonylurea, DPP4 inhibitors or SGLT2 inhibitors as a second antidiabetic drug in patients with diabetes mellitus type 2 in treatment with metformin and insufficient glycemic control. |
Dr Josep Franch-Nadal |
05/05/2018 |
