PAS funded by this sponsor. EU PAS ID Status RMP requirementTitle Protocol uploaded Results uploaded 2717 Finalised EU RMP category 3 Cohort Study of Pioglitazone and Bladder Cancer in Patients with Type II Diabetes No Yes 2946 Ongoing Unspecified WP6 Replication Study: The risk of acute liver injury associated with the use of antibiotics: Population based case control study No No 3626 Finalised EU RMP category 3 Pan European Multi-Database Bladder Cancer Risk Characterisation Study Yes Yes 6147 Finalised Not included in RMP Real-world effectiveness of extra-fine Ciclesonide (Alvesco®) versus standard particle inhaled corticosteroid (ICS) Yes No 6469 Finalised EU RMP category 3 MLN-0002_401: Entyvio (vedolizumab) long-term safety study: : An international observational prospective cohort study comparing vedolizumab to other... Yes Yes 7998 Finalised Not included in RMP Drug Utilization Study for azilsartan medoxomil in Germany Yes Yes 8408 Finalised EU RMP category 3 Assessment of Utilisation of Pioglitazone in Denmark Post Label Change (July 2011) No Yes 8734 Finalised Not included in RMP Alogliptin-5002: Association between therapy with Dipeptidyl peptidase-4 (DPP-4) inhibitors and risk of ileus: A cohort study No Yes 9159 Finalised Not included in RMP Monitoring for proteinuria in patients with type 2 diabetes mellitus (Proteinuria monitoring in type 2 diabetes) No No 9924 Finalised EU RMP category 3 Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge and Attitudes on... Yes Yes 9995 Finalised EU RMP category 3 A study on the utilization of pioglitazone in clinical practice in the UK after the label change in July 2011 No Yes 9998 Finalised EU RMP category 3 A Study on the Utilization of Pioglitazone in Clinical Practice With Regard to Diabetic Treatment Regimen and Comorbidities No Yes 10001 Finalised EU RMP category 3 A PHARMO Study on the Utilization of Pioglitazone in Clinical Practice in The Netherlands with Regard to Diabetic Treatment Regimen and Co-morbidities Yes Yes 10335 Finalised EU RMP category 3 Cohort Study of Pioglitazone and Cancer Incidence in Patients with Diabetes Mellitus Yes Yes 10493 Finalised Not included in RMP PROspective PioglitAzone Clinical Trial in MacroVascular Events (PROactive) No No 10513 Finalised EU RMP category 3 An observational study of patient cohorts who previously received long-term treatment with pioglitazone or placebo in addition to existing... Yes Yes 11681 Ongoing Non-EU RMP-only Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry No No 11750 Finalised Not included in RMP Exposure to pioglitazone and the risk of prostate cancer: a nested case-control study No Yes 12537 Finalised Not included in RMP Vedolizumab-5028: A Retrospective UK Chart Review of Early Vedolizumab (Entyvio®) Experience: Real World Treatment, Effectiveness and Safety in... No 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 15737 Finalised Not included in RMP Ferumoxytol-5005: Hypersensitivity events occurring proximal to administration of intravenous iron No Yes 16082 Finalised Not included in RMP Pioglitazone Use and Risk of Bladder Cancer: a Systematic Review and Meta-Analysis of Observational Studies Yes Yes 16564 Finalised Not included in RMP Incidence of Surgical Site Infections After Lower Gastrointestinal Surgery in Patients With Crohn’s Disease or Ulcerative Colitis No Yes 18735 Finalised EU RMP category 3 Drug Utilisation Study of Intuniv® (guanfacine extended release) in European Countries, Study protocol I: Database study (Intuniv data base study... Yes Yes 18739 Finalised EU RMP category 3 Drug utilisation study of Intuniv® (guanfacine extended release) in European Countries – A prescriber survey (Intuniv survey study Europe) Yes Yes 19582 Finalised Not included in RMP An Observational Cohort Study on Multiple Myeloma Patients in Finland Yes Yes 19669 Finalised Not included in RMP ENTYVIO® Outcomes in Real-world, Bio-naïve Ulcerative Colitis and Crohn’s Disease Patients (EVOLVE)—Greece (EVOLVE-Greece) No Yes 21846 Finalised Not included in RMP An International, Multi-Centre, Retrospective Study to Describe Treatment Pathways, Outcomes, And Resource Use in Patients with Multiple Myeloma ... Yes Yes 22735 Finalised Not included in RMP A Swedish Observational Study on Vedolizumab Assessing Effectiveness And Healthcare Resource Utilization in Patients with Inflammatory Bowel Disease... No Yes 22954 Finalised Not included in RMP A multi-centre observational study to describe the impact of vedolizumab on concomitant prescribing and quality of life in patients with ulcerative... No Yes 23580 Ongoing Not included in RMP Vedolizumab-4018: Observational Study of the Effectiveness of Vedolizumab on Treatment Outcomes and HRQoL in biologic naïve Patients with Inflammatory... No No 23658 Finalised Not included in RMP Experiences of using vedolizumab in the East Midlands, United Kingdom: A retrospective observational study No Yes 23702 Ongoing Not included in RMP Vedolizumab-4020: A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Vedolizumab in Indian Patients With... No No 24267 Ongoing Not included in RMP Alofisel-5003: An Observational Post-Marketing Registry on the Effectiveness and Safety of Darvadstrocel in Patients With Crohn's Disease and Complex... No No 25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No 25741 Finalised Not included in RMP Retrospective Observational Study to Describe Treatment Patterns and Health care Resource Utilization Associated With Complex Perianal Fistula in... No No 25761 Finalised Not included in RMP Retrospective observational study on the effect of vedolizumab treatment on patients with inflammatory bowel disease and extraintestinal... No Yes 27544 Finalised Not included in RMP Safety and Effectiveness of Vedolizumab IV in Real World Clinical Practice in Taiwan: A Registry-Based Study Yes Yes 27731 Finalised Not included in RMP INSPECT: A retrospectIve chart review study evaluating the longer-term effectiveness of darvadstrocel in patients who completed ADMIRE-CD No No 28791 Finalised Not included in RMP A Retrospective Observational Study to describe the Effectiveness and Safety of Vedolizumab With or Without Budesonide Induction Therapy Among... No Yes 28930 Finalised Not included in RMP An Observational/Non-interventional Evaluation of Subject Outcomes for Type 2 Diabetes Mellitus (T2DM) Subjects Prescribed Dipeptidyl Peptidase-4... No Yes 29153 Finalised Not included in RMP Evaluating the cost and clinical outcomes of changing type 2 diabetes mellitus patients from current DPP-4 inhibitor treatment to alogliptin in a... No Yes 29813 Finalised EU RMP category 3 Evaluation of the Effectiveness of Risk Minimisation Measures: A Survey among Health Care Professionals to Assess their Knowledge on Dosing and... No No 30733 Ongoing Not included in RMP C16050: A national, prospective, non-interventional study of using NINLARO® in real world clinical practice No No 31439 Ongoing EU RMP category 3 Alofisel-4001: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s... No No 31926 Finalised Not included in RMP A Global Cross-sectional Survey to Capture Awareness and Knowledge of Mesenchymal Stem Cell (MSC) Therapy by Gastroenterologists and Colorectal... No Yes 32383 Ongoing EU RMP category 3 Brigatinib-5007: A Cohort Study to Describe the Occurrence of Early-Onset Pulmonary Events in Patients with Anaplastic Lymphoma Kinase-Positive... Yes No 32684 Ongoing Not included in RMP Vedolizumab-5055: Long Term Outcomes of Drug Program for Biological Treatment in Adult Patients With Ulcerative Colitis in Poland (MAZUREK Study) No No 32716 Ongoing Not included in RMP Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective,... No No 32913 Ongoing Not included in RMP Vedolizumab-4024: A Multi-center, Longitudinal, Observational Study of the Effectiveness of Vedolizumab on Clinical Outcomes and Health-Related... No No 34119 Finalised Not included in RMP Vedolizumab-5050: Clinical Perspective of Vedolizumab (Entyvio) use in the Drug Program "Vedolizumab in the Treatment of Ulcerative Colitis" (POLONEZ) Yes Yes 34232 Finalised Not included in RMP Vedolizumab-5060: Association Between Disease Activity and QoL, Fatigue, Mood and Sleep Disorders in Patients with Moderate to Severe Ulcerative... Yes Yes 34614 Ongoing Not included in RMP A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People with Severe Von Willebrand Disease (VWD) (ATHN 9:... No No 36934 Ongoing Not included in RMP Brentuximab-5014: Brentuximab Vedotin Administration Registry and Outcomes Study in Polish CTCL Patients (BV-BALTIC study) No No 37806 Ongoing Not included in RMP TAK-906-5003: Real-world Evidence on Diagnosed Gastroparesis in Europe: Multi-database Observational Epidemiological Study No No 40105 Ongoing Non-EU RMP-only TAK-555-4006: A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® (prucalopride) for Chronic Idiopathic... No No 40179 Finalised Not included in RMP Febuxostat-5006: Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed... Yes Yes 40231 Ongoing Non-EU RMP-only TAK-555-5001: Prucalopride Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance of Prucalopride Safety in Pregnancy No No 41308 Finalised EU RMP category 3 Instanyl-5002: Assessment of the Effectiveness of Updated Educational Materials on Prescribers’ Knowledge and Behavior with Respect to Risks... Yes Yes 41643 Planned EU RMP category 3 Alofisel-5005: An Observational European Multi-database Linkage Study to Quantify Malignancy Rates in Crohn’s Disease Patients With Complex Perianal... No No 41735 Finalised EU RMP category 2 A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients - the... Yes Yes 41866 Ongoing Non-EU RMP-only TAK-555-5002: Observational Study to Assess Maternal and Fetal Outcomes Following Exposure to Prucalopride during Pregnancy No No 44653 Ongoing Not included in RMP C25023: Effectiveness and Safety for Re-treatment with Brentuximab-Vedotin (BV) in Patients with Relapsed/Refractory (R/R) CD30+ malignancies: a... No No 45617 Ongoing EU RMP category 3 TAK-577-4005: Estimating Risk of Selected Adverse Events in Patients with Von Willebrand Disease Treated With VEYVONDI® (Vonicog Alfa; Recombinant Von... Yes No 46101 Finalised Not included in RMP TAK-771-4002: Evaluating the Safety of GAMMAGARD LIQUID for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Yes Yes 48289 Finalised Not included in RMP Vedolizumab-4030: Understand the Outcomes of Inflammatory Bowel Disease (IBD) Patients Treated with Biologics in Taiwan – A Decentralized Vedolizumab... Yes Yes 48683 Planned Not included in RMP World Federation of Hemophilia Gene Therapy Registry (WFH GTR) No No 49598 Planned EU RMP category 3 TAK-669-4018: A Survey Among Patients, Caregivers and Home Infusion Nurses Based in the European Union to Assess Their Awareness and Understanding of... No No 50308 Finalised Not included in RMP Evaluate the Real-World Safety Outcomes and Clinical Efficacy of Ponatinib and Other Tyrosine Kinase Inhibitors among Chronic Myeloid Leukemia... Yes Yes 103800 Finalised Not included in RMP TAK-771-4004: Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims... Yes Yes 104398 Ongoing Not included in RMP Evaluation of the Effectiveness of Risk Minimization Measures: A Survey Among Pharmacists to Assess the Impact of the RMP Material for Patients on... No No 104804 Planned Not included in RMP Brentuximab-5020_Real-world Evidence Study on Brentuximab Vedotin Retreatment Outcomes of Cutaneous T-cell Lymphoma Patients No No