Results (4016)
OPCRD ADEPT application Study Protocol
United Kingdom
EU PAS number:
EUPAS1000000164
First published:
02/07/2024
StudyFinalised
Fin-CARING2
Finland
First published:
02/07/2024
Data source
Cancer registryHospital discharge recordsPharmacy dispensing recordsA multi-center prospective non-interventional study to understand the use of next generation sequencing (NGS) in patients with metastatic non-small cell lung cancer and metastatic colorectal cancer in Belgium.
Belgium
EU PAS number:
EUPAS107702
First published:
02/07/2024
StudyPlanned
Active Safety Surveillance of the Pfizer-BioNTech COVID-19 Vaccine in the United States Department of Defense Population Following Emergency Use Authorization
United States
EU PAS number:
EUPAS50375
First published:
02/07/2024
StudyFinalised
Safety and effectiveness of RZV in adults ?18 years of age with Systemic lupus erythematosus (SLE) or Multiple sclerosis (MS) (EPI-ZOSTER-041 VS US DB 215104)
United States
EU PAS number:
EUPAS107073
First published:
02/07/2024
StudyOngoing
Non-interventional post-authorization effectiveness study to assess long-term outcomes of Nintedanib treatment in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) (Nintedanib long-term outcomes in patients with SSc)
Argentina
Armenia
Austria
Belgium
Brazil
Bulgaria
Canada
China
Croatia
Czechia
Denmark
Dominican Republic
Egypt
Estonia
Finland
France
Germany
Greece
Hungary
Iran, Islamic Republic of
Ireland
Israel
Italy
Japan
Lithuania
Malta
Moldova, Republic of
Montenegro
Netherlands
New Zealand
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Slovenia
South Africa
Spain
Sweden
Switzerland
Türkiye
Ukraine
United Kingdom
United States
EU PAS number:
EUPAS106792
First published:
02/07/2024
StudyPlanned
Post-AuthorisationActive Safety Surveillance Program Among Patients Treated With Tofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Juvenile Psoriatic Arthritis (PsA) Using Nationwide Swedish Healthcare Registers
Sweden
EU PAS number:
EUPAS107199
First published:
02/07/2024
StudyPlanned
Post-Authorisation Active Safety Surveillance Program Among Patients Treated WithTofacitinib for Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Juvenile Psoriatic Arthritis (PsA) Within the United Kingdom (UK) Juvenile Idiopathic Arthritis (JIA) Biologics Register
United Kingdom
EU PAS number:
EUPAS107203
First published:
02/07/2024
StudyPlanned
Effectiveness of the Novavax COVID-19 Vaccine in Reducing Clinically Defined Severe SARS-CoV-2 Infection in Individuals ≥ 12 Years of Age in the United States
United States
EU PAS number:
EUPAS105521
First published:
02/07/2024
StudyOngoing
Tecartus Survey: Quantitative Testing of Health Care Professional Knowledge About Tecartus® Risk Minimisation Measures
Czechia
France
Germany
Italy
Netherlands
Poland
Portugal
Spain
United Kingdom
EU PAS number:
EUPAS104052
First published:
02/07/2024
StudyOngoing
Incretin-based therapies and Pancreatic Cancer risk in Medicare enrollees – new user protocol
United States
EU PAS number:
EUPAS3255
First published:
02/07/2024
StudyFinalised
Evaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European before-after drug utilization study (DUS) using secondary data
France
Germany
Spain
Sweden
EU PAS number:
EUPAS32302
First published:
02/07/2024
StudyFinalised
A Postmarketing Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG® (ponatinib) in Routine Clinical Practice in the US (OMNI)
United States
EU PAS number:
EUPAS9097
First published:
02/07/2024
StudyFinalised
AN OBSERVATIONAL, LONGITUDINAL, PROSPECTIVE, LONG-TERM REGISTRY OF PATIENTS WITH HYPOPHOSPHATASIA (ALX-HPP-501)
Australia
Austria
Canada
France
Germany
Italy
Japan
Poland
Saudi Arabia
Spain
United Kingdom
United States
EU PAS number:
EUPAS13514
First published:
02/07/2024
StudyOngoing
Longitudinal Analyses of Body Mass Index and Risk of Parkinson's Disease in 2 million people over 2 decades (BMI and Parkinson´s disease)
Spain
United Kingdom
EU PAS number:
EUPAS23454
First published:
02/07/2024
StudyOngoing
Database Study of Thalidomide (Thalidomide Celgene®) in Germany: Monitoring Off-Label Use
Germany
EU PAS number:
EUPAS7020
First published:
02/07/2024
StudyFinalised
Post-Marketing surveillance for HPV infection related serious disease in a cohort of Chinese women who received GARDASIL® and GARDASIL®9
China
EU PAS number:
EUPAS36135
First published:
02/07/2024
StudyFinalised
Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey and Drug Utilisation Study among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of valproate in France, Germany, Spain, Sweden and United Kingdom
France
Germany
Spain
Sweden
United Kingdom
EU PAS number:
EUPAS11379
First published:
02/07/2024
StudyFinalised
Non-interventional, post-authorization efficacy study to assess the consistency of Breyanzi product quality and clinical outcomes in patients treated for relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and follicular lymphoma Grade 3B after 2 or more lines of systemic therapy in the post-marketing setting (CA082-1105)
Austria
Belgium
Croatia
Czechia
Denmark
Finland
France
Germany
Greece
Italy
Netherlands
Norway
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
EU PAS number:
EUPAS103852
First published:
02/07/2024
StudyPlanned
A Post-Authorization, Multicenter, Multinational, Longitudinal, Observational Safety Registry Study for Patients Treated with Voretigene Neparvovec
Argentina
Austria
Brazil
Canada
Denmark
Finland
France
Germany
Israel
Italy
Korea, Democratic People's Republic of
Mexico
Netherlands
Norway
Russian Federation
Saudi Arabia
Singapore
Sweden
Switzerland
Taiwan
Türkiye
United Arab Emirates
United Kingdom
EU PAS number:
EUPAS31153
First published:
02/07/2024
StudyOngoing
Observational study of exposure to baricitinib during pregnancy in US-based administrative claims data (I4V-MC-B036)
United States
EU PAS number:
EUPAS49806
First published:
02/07/2024
StudyPlanned
Implementation of EU risk minimisation measures for medicinal products in clinical guidelines
Denmark
Greece
Latvia
Netherlands
Portugal
Slovenia
EU PAS number:
EUPAS47588
First published:
02/07/2024
StudyFinalised
Statistical methods for time-to-event endpoints with non-proportional hazards in clinical trials pivotal for benefit risk decision making
Austria
Germany
Sweden
EU PAS number:
EUPAS46420
First published:
02/07/2024
StudyFinalised
Impact of biologic initiation on steroid burden and new-onset of potentially OCS-related outcomes in patients with severe asthma (SOLAR)
Argentina
Australia
Bulgaria
Canada
Colombia
Denmark
Greece
Hungary
India
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Mexico
Poland
Portugal
Saudi Arabia
Singapore
Spain
Taiwan
United Arab Emirates
United Kingdom
United States
EU PAS number:
EUPAS104139
First published:
02/07/2024
StudyPlanned
Registry based observational study to assess pregnancy and infant outcomes following exposure to baricitinib in pregnancy (I4V-MC-B035)
United States
EU PAS number:
EUPAS49999
First published:
02/07/2024
StudyPlanned
Survey to Assess the Effectiveness of SPRAVATO® Educational Materials for Additional Risk Minimization Measures in the European Union (PCSNSP002812)
Germany
Sweden
EU PAS number:
EUPAS38144
First published:
02/07/2024
StudyPlanned
Evaluation of the Effectiveness of a Xospata Routine Risk Minimisation Measure (RMM) and an Additional Risk Minimisation Measure (aRMM): A Cross-sectional Survey Study among Healthcare Professionals to Assess Awareness and Knowledge
Czechia
France
Germany
Italy
Netherlands
Sweden
EU PAS number:
EUPAS37354
First published:
02/07/2024
StudyFinalised
A Non-interventional Post-authorisation Safety Study (PASS) as an Effectiveness Check of the Prescriber Checklist for Mycamine® (micafungin)
France
Germany
Greece
Netherlands
Poland
Spain
Sweden
EU PAS number:
EUPAS35011
First published:
02/07/2024
StudyFinalised
Cidofovir Exposure Registry Study (CERS)
Belgium
Germany
Spain
United Kingdom
EU PAS number:
EUPAS33124
First published:
02/07/2024
StudyOngoing
A European Study of the Effectiveness of Risk Minimisation Measures for Fenfluramine in Dravet Syndrome (TAPESTRY eRMM)
Austria
Denmark
France
Germany
Italy
Spain
United Kingdom
EU PAS number:
EUPAS48741
First published:
02/07/2024
StudyOngoing
A non-interventional, open observational non-inferiority study in two cluster-assigned cohorts of children aged 14 months into the safety of NeisVac-C® vaccines manufactured at two different production sites and given simultaneously with measles-mumps-rubella vaccine, assessed by web-based intensive monitoring (Peuterprik)
Netherlands
EU PAS number:
EUPAS5937
First published:
02/07/2024
StudyFinalised
Clinical validation study of a CAD system with artificial intelligence algorithms for early non-invasive detection of in vivo cutaneous melanoma. (LEGIT_MC_EVCDAO_2019)
Spain
EU PAS number:
EUPAS108254
First published:
02/07/2024
StudyFinalised
Data source heterogeneity in multi-database pharmacoepidemiologic studies: a scoping review (DIVERSE)
Italy
Netherlands
United Kingdom (Northern Ireland)
EU PAS number:
EUPAS39757
First published:
02/07/2024
StudyOngoing
Exploring different composite definitions of responders and non-responders to biologic treatment for severe asthma (FULL BEAM)
Argentina
Australia
Bulgaria
Canada
Colombia
Denmark
Greece
India
Ireland
Italy
Japan
Korea, Republic of
Kuwait
Mexico
Poland
Portugal
Saudi Arabia
Taiwan
United Arab Emirates
United Kingdom
United States
EU PAS number:
EUPAS104132
First published:
02/07/2024
StudyPlanned
Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence (ValproateRiskAware)
Belgium
Denmark
Greece
Latvia
Netherlands
Portugal
Slovenia
Spain
EU PAS number:
EUPAS32405
First published:
02/07/2024
StudyFinalised
Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive pulmonary disease using health insurance claims data provided by Medical Data Vision Co., Ltd. in Japan (212606)
Japan
EU PAS number:
EUPAS44882
First published:
02/07/2024
StudyOngoing
Observational Safety Data Analysis from Routine Follow-up in the EuroSIDA Study of Patients Treated with Raltegravir in a Five-Year Post Authorization Period (MK-0518-058)
Argentina
Austria
Belarus
Belgium
Bulgaria
Croatia
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
EU PAS number:
EUPAS17912
First published:
02/07/2024
StudyFinalised
Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2017/2018 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-20)
Hungary
EU PAS number:
EUPAS18936
First published:
02/07/2024
StudyFinalised
Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and Attitudes on Prescribing Conditions of Thiocolchicoside containing Medicinal Products for Systemic Use in France, Greece, Italy and Portugal
France
Greece
Italy
Portugal
EU PAS number:
EUPAS11765
First published:
02/07/2024
StudyFinalised
Post-Marketing surveillance for the safety of GARDASIL® and GARDASIL®9 in a cohort of Chinese women
China
EU PAS number:
EUPAS36132
First published:
02/07/2024
StudyFinalised