PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 2353 Finalised Not included in RMP The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources Yes No 2356 Finalised Not included in RMP Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish... Yes Yes 2382 Finalised Not included in RMP Use of antidepressants and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design Yes No 2385 Ongoing Unspecified Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design. Yes No 2388 Ongoing Unspecified Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of... Yes No 2561 Ongoing Unspecified Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data... Yes No 2628 Finalised Unspecified Asthma treatment in pregnancy and the frequency of adverse pregnancy outcomes (WEUSRTP4850) Yes Yes 3310 Finalised EU RMP category 3 114101 - Post-marketing safety study to assess the risk of spontaneous abortions in women exposed to Cervarix in the United Kingdom Yes Yes 4093 Finalised Not included in RMP WEUSKOP6416: Evaluating severe events in patients with Chronic Obstructive Pulmonary Disease (COPD) to inform risk minimization: A Retrospective... Yes Yes 4126 Finalised EU RMP category 3 WEUKBRE5744: European Survey of Patient and Prescriber Understanding of Risks Associated with TROBALT™ (116771) Yes Yes 4129 Finalised Not included in RMP 5ARI and Prostate Cancer Mortality Study (116059) Yes Yes 4584 Finalised EU RMP category 3 116239 - An observational cohort study to assess the risk of autoimmune diseases in adolescent and young adult women aged 9 to 25 years exposed to... Yes Yes 4851 Finalised EU RMP category 3 Prescriber and Pharmacist Understanding of the Risk of Urinary Retention with POTIGA (116490) Yes Yes 4966 Ongoing EU RMP category 1 SABLE: A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active,... Yes No 5049 Finalised EU RMP category 3 Retrospective Case‐Control Studies of Rare Adverse Events Associated with Intranasal Steroids (201077) Yes Yes 5306 Finalised Not included in RMP Study of healthcare consumption of patients over 45 years with Chronic Obstructive Pulmonary Disease No No 5418 Ongoing Unspecified Pertussis in Pregnancy Safety (PIPS) Study Yes No 5568 Finalised EU RMP category 3 PRJ2215: Assessment of Bupropion Misuse/Abuse 2004-2011 (201235) Yes Yes 6186 Finalised EU RMP category 3 Survey of prescriber understanding of specific risks associated with TROBALT (201426) Yes Yes 6189 Finalised EU RMP category 3 PGx6652: Genetic Evaluation of Pazopanib –Related Hepatotoxicity (117365) Yes Yes 6229 Finalised EU RMP category 3 Votrient Liver Data Meta-analysis (200276) Yes Yes 6234 Finalised EU RMP category 3 PGx447:Exploratory genetic analysis of pazopanib (GW786034) related diarrhea in patient with RCC(VEG102616,VEG105192,VEG107769) (116054) Yes Yes 6242 Finalised Not included in RMP Votrient liver data meta-analysis of phase II and III RCC and STS studies (200277) Yes Yes 6441 Finalised EU RMP category 3 ZYB117211: Plan to Assess the Incidence of Cardiovascular Related Adverse Events in Controlled Clinical Trials of Bupropion for the Treatment of... No No 6577 Finalised EU RMP category 3 WEUKBRE6076: Benlysta Pregnancy Registry (BPR) - Prospective cohort study of pregnancy outcomes following Benlysta exposure within 4 months prior to... Yes Yes 6655 Finalised EU RMP category 3 Physician Adherence to Fondaparinux Prescribing Information for Patients with Superficial Vein Thrombosis (SVT) of the Lower Limbs (115280) Yes No 6969 Finalised EU RMP category 3 REVIEU - A multinational, retrospective, observational drug utilisation study of REVOLADE™ (eltrombopag) In selected countries in the European Union... Yes Yes 7305 Finalised EU RMP category 3 WEUSKOP7134: A prospective, observational cohort study nested within the HCV Research UK National Registry to evaluate real-world use of eltrombopag... Yes Yes 7361 Finalised EU RMP category 3 PGx7610: Genetic Evaluation of Hepatotoxicity in Pazopanib Studies (201761) Yes Yes 7761 Finalised Not included in RMP Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC... Yes Yes 7766 Finalised Non-EU RMP-only PGX7550: PGx Investigation of Pyrexia by Meta-Analysis of Dabrafenib/Trametinib Melanoma Studies BRF113710, BRF113929, BRF113683 and MEK115306... Yes Yes 7953 Finalised Non-EU RMP-only PGx7607: PGx evaluation of pyrexia by meta-analysis of melanoma subjects from BRF113710, BRF113929, BRF113683, MEK115306 and MEK116513 (202050) Yes Yes 8093 Finalised Not included in RMP Study of Cervarix & Idiopathic Thrombocytopenic Purpura using the PGRx information system Yes Yes 8375 Finalised EU RMP category 3 Can social listening data be used to provide meaningful insights into abuse or inappropriate use of bupropion? (A feasibility analysis) (202115) Yes Yes 8615 Finalised Unspecified Lamotrigine use in Pregnancy and Risk of Orofacial Clefts No No 8618 Finalised Not included in RMP Lamotrigine use in Pregnancy and Risk of Orofacial Clefts II No No 9868 Finalised Non-EU RMP-only Drug Use Investigation of ANORO ELLIPTA inhaler (200311) Yes Yes 10224 Finalised Non-EU RMP-only Encruse Ellipta Drug Use Investigation (201450) Yes Yes 10316 Ongoing EU RMP category 1 Post-authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and... Yes No 10376 Finalised Non-EU RMP-only PRJ2282/201491: CHESS: CPRD-COPD Hawthorne Effect Study in Salford: A UK cohort study to characterise patients enrolled in the Salford Lung Study and... Yes No 10416 Finalised EU RMP category 3 205514 (V72_38OB) - Post-licensure observational effectiveness study of meningococcal B vaccine 4CMenB (Bexsero®) vaccination Yes No 10464 Finalised Not included in RMP PGx7612: Pharmacogenetic investigation of the association of the ADRB2 rare variant, Thr164Ile with severe asthma exacerbation (204661) Yes Yes 11397 Finalised Non-EU RMP-only An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of ANORO administered in Korean subjects with... Yes Yes 11405 Finalised EU RMP category 3 Meta-Analysis Plan for Study Number 201182, GSK1550188, SLE, Pregnancy Analysis Yes Yes 11845 Finalised EU RMP category 3 An Observational Study of the Risk of Acute Pancreatitis in Subjects Exposed to Albiglutide, Other GLP-1 Agonists or DPP-4 Inhibitors Compared to... Yes Yes 12436 Finalised EU RMP category 3 Drug Utilization Study for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray (205708) Yes No 12518 Finalised EU RMP category 3 Post-marketing study of ropinirole prolonged release tablets in Parkinson’s disease: Evaluation outcomes associated with long term use of... Yes Yes 12703 Finalised Not included in RMP Zagallo Capsules Drug Use Investigation (202029) Yes Yes 13766 Finalised Not included in RMP Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of... Yes Yes 13772 Ongoing EU RMP category 3 The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy (200870 NPSS (Nucala Pregnancy... Yes No 13908 Finalised Not included in RMP ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and... Yes Yes 14947 Finalised Not included in RMP An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and efficacy of INCRUSE administered in Korean subjects with... Yes Yes 17720 Finalised EU RMP category 3 Drug utilisation study of new users of fluticasone furoate / vilanterol (FF/VI) in the primary care setting: UK Clinical Practice Research Datalink... Yes Yes 17926 Finalised Non-EU RMP-only Nucala Subcutaneous Injection Special Drug Use Investigation (Long-Term) (204524) Yes No 21362 Finalised Non-EU RMP-only Meta-Analysis Plan for MID207941: A Study to Evaluate Risk Factors for Pneumonia and Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in a... Yes No 22912 Finalised Not included in RMP 207221 - An observational, retrospective cohort database study to assess the safety of Boostrix (U.S. formulation), a reduced tetanus, diphtheria,... Yes Yes 27806 Ongoing Not included in RMP Prevalence of COPD patients with signs of asthma according to Dutch GP guidelines No No 28541 Ongoing EU RMP category 3 115056 - A prospective study to evaluate the safety, effectiveness and impact of the RTS, S/AS01E vaccine in young children in sub-Saharan Africa... Yes No 28551 Finalised Not included in RMP PATTERNS OF CLINICAL MANAGEMENT OF ASTHMATIC PATIENTS WITH EXACERBATIONS IN THE REAL-WORLD SETTING IN THE NATIONAL HEALTH SYSTEM Yes No 29407 Ongoing EU RMP category 3 Post-authorization safety study to evaluate the risks of myelodysplastic syndrome/acute myeloid leukemia and second primary malignancies in adult... Yes No 29817 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2018/19 (DRIVE 2018/19) Yes Yes 30792 Finalised Not included in RMP AIV - FISABIO Impact and risk of Herpes Zoster in immunosuppressed subjects in Valencia Region, Spain Yes No 33189 Planned EU RMP category 3 Zanamivir 10mg/ml solution for infusion pregnancy registry: an observational study of the safety of zanamivir 10mg/ml solution for infusion exposure... Yes No 35147 Ongoing Not included in RMP Real-time systematic review and meta-analysis of non-randomised comparative treatment studies for COVID-19 No No 35685 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2019/20 (DRIVE 2019/20) Yes Yes 37133 Finalised EU RMP category 3 209696 - A targeted safety study, EPI-ZOSTER-032 VS US DB, to evaluate the safety of Shingrix in adults ≥ 65 years of age in the United States. Yes No 37156 Ongoing EU RMP category 3 209452 - A targeted safety study, EPI-ZOSTER-030 VS US DB, to evaluate the safety of Shingrix in adults ≥ 50 years of age in the United States Yes No 37605 Ongoing Not included in RMP A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in... Yes No 38199 Planned Not included in RMP Addressing the burden of respiratory disease in General Practice: A real-life implementation study focusing on high risk asthma and COPD patients No No 38374 Finalised EU RMP category 3 Observational study to assess frailty of subjects during ZOSTER-006 and ZOSTER-022 and HZ efficacy, immunogenicity and safety of HZ/su by frailty... Yes Yes 38633 Ongoing EU RMP category 3 209570 - Long-Term Effectiveness Study of Shingrix in Adults ≥ 50 Years of Age in the US (EPI-ZOSTER-031 VE US) Yes No 38868 Planned Not included in RMP Nation-wide health resource consumption and costs associated with mepolizumab (Nucala): a French SNDS database study (Resala) Yes No 40313 Ongoing Non-EU RMP-only TRELEGY ELLIPTA General Drug Use Investigation (asthma) Yes No 40875 Finalised Not included in RMP DRIVE Brand-specific influenza vaccine effectiveness in Europe, season 2020/21 (DRIVE 2020/21) Yes Yes 42275 Ongoing EU RMP category 3 BEL116559 Pooled Analysis of Belimumab Elderly Patients Yes No 42373 Finalised EU RMP category 3 217743 - An observational, retrospective database post-authorisation safety study (PASS) to assess trends and changes over time in incidence of anal... Yes No 42517 Ongoing EU RMP category 3 COVID-19 International Drug Pregnancy Registry (COVID-PR) No No 42948 Ongoing EU RMP category 3 205071 - A phase IV, longitudinal, cross-sectional, retrospective, ancillary epidemiology study of the EPI-MAL-005 study to evaluate the genetic... Yes No 43810 Planned Not included in RMP Risk of Herpes Zoster in individuals diagnosed with COVID19 infection in the Valencia region of Spain: a retrospective cohort population-based study... Yes No 43920 Ongoing EU RMP category 3 116682 - An epidemiology study to assess Plasmodium falciparum parasite prevalence and malaria control measures in catchment areas of two studies pre-... Yes No 44701 Ongoing Not included in RMP BLENREP Effectiveness and Safety in Multiple Myeloma (BEaMM) – Real-World Evidence on Patients Taking Belantamab Mafodotin in Europe (217240) No No 44882 Ongoing Non-EU RMP-only Cohort study to estimate incidence of pneumonia in users of Trelegy 100 or multiple inhaler triple therapy among patients with chronic obstructive... Yes No 45288 Finalised EU RMP category 3 115055-A prospective study to estimate the incidence of diseases specified as adverse events of special interest, of other adverse events leading to... Yes No 46386 Ongoing Non-EU RMP-only Prospective cohort study to monitor the emergence of SARSCoV-2 spike viral variants in immunocompromised nonhospitalised patients exposed to... No No 46662 Ongoing Non-EU RMP-only 212853 - Shingrix for intramuscular injection Drug Use Investigation Yes No 46820 Finalised Not included in RMP Analysis of BLyS-dependent signatures and biology in the intestinal mucosa of patients with inflammatory bowel disease Yes Yes 46888 Finalised Not included in RMP DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2021/22 (DRIVE 2021/22) Yes Yes 47006 Finalised EU RMP category 3 An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a... No No 47064 Finalised Not included in RMP CONOCEPOC 2020: Study promoted by the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) Yes Yes 47885 Ongoing Not included in RMP Investigating biases in observational studies of inhaled corticosteroids and the risk of COVID-19-related outcomes Yes No 49460 Planned EU RMP category 3 A post-authorisation safety study (PASS) to describe real-world safety and effectiveness of NUCALA (mepolizumab) in paediatric eosinophilic... No No 49554 Ongoing Not included in RMP The Belimumab Pregnancy Exposure Study: An OTIS Autoimmune Diseases in Pregnancy Project (213928) No No 103405 Planned Not included in RMP Symptom Online Monitoring (SYMON) Yes No 103974 Finalised Non-EU RMP-only XEVUDY General Drug Use Investigation (SARS-CoV-2 Infection) - COVID-19 (217893) Yes No 104070 Ongoing Not included in RMP Postmarketing commitment safety study of HZ/su to evaluate pregnancy exposures and outcomes in immunodeficient or immunosuppressed women between 18... Yes No 105107 Ongoing Not included in RMP An OTIS/MotherToBaby Pregnancy Registry-based observational cohort study to evaluate pregnancy and infant outcomes in individuals exposed to Boostrix... Yes No 105374 Ongoing Not included in RMP Anti-IL-5/5R versus anti-IL4R switching strategies for uncontrolled severe asthma treated by anti-IL5/5R : A target trial emulation (RAMSES-Switch) No No 105378 Ongoing Not included in RMP Treatable Traits in patients with Obstructive Lung Disease in Dutch primary care No No 107073 Ongoing Not included in RMP 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... Yes No 107206 Ongoing Not included in RMP A retrospective matched cohort study on the association between herpes zoster vaccination and dementia and mild cognitive impairment using electronic... No No 107230 Ongoing Not included in RMP Non-interventional (observational) post-licensure study to assess the effectiveness and safety of recombinant zoster vaccine in adults aged ?18 years... Yes No