Bayer

This sponsor has funded 75 studies across 55 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
1597 Finalised EU RMP category 3 International Active Surveillance study - Folate and Oral Contraceptive Utilization Study (INAS-FOCUS) Yes Yes
1613 Finalised EU RMP category 3 International Active Surveillance Study of Women Taking Dienogest for Endometriosis: Visanne Post-approval Observational Study (VIPOS) Yes Yes
2679 Finalised EU RMP category 3 SURVEILLANCE STUDY OF PHOTOCONTACT DERMATITIS LEADING TO HOSPITALIZATION IN EUROPE WITH A SPECIAL FOCUS ON TOPICAL KETOPROFEN AND OTHER TOPICAL... Yes No
3911 Finalised EU RMP category 3 Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages Yes Yes
3979 Finalised EU RMP category 3 An Observational Post-Authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of Rivaroxaban... Yes Yes
4564 Finalised Not included in RMP OPTIMIS - Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib Yes Yes
4934 Finalised Not included in RMP RECORA- Regorafenib in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy Yes Yes
5944 Finalised Not included in RMP Correlate - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings Yes Yes
6115 Finalised EU RMP category 3 EXPERT, EXPosurE Registry RiociguaT in patients with pulmonary hypertension Yes Yes
6476 Ongoing EU RMP category 1 European Active Surveillance Study of LCS12 (EURAS-LCS12) Yes No
7187 Ongoing EU RMP category 3 Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation (REASSURE) Yes No
8365 Finalised EU RMP category 1 Drug Utilization Study on the Prescribing Indications for CPA/EE in 5 European Countries Yes Yes
8412 Finalised EU RMP category 1 Drug utilization study of cyproterone/ethinylestradiol (Diane®-35 and generics) in the Netherlands, UK and Italy Yes Yes
8494 Finalised EU RMP category 3 A Drug Utilization Study of Xofigo Use in Sweden Yes Yes
8498 Finalised EU RMP category 3 Pharmacoepidemiological study (Drug Utilization Study) of JAYDESS use in routine clinical practice in Sweden (Jaydess DUS) Yes Yes
9020 Finalised Not included in RMP PARABO - Pain evaluation in Radium-223 (Xofigo®) treated mCRPC patients with bone metastases – a non-interventional study in nuclear medicine centers Yes Yes
9312 Finalised EU RMP category 1 Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation... Yes Yes
9895 Finalised EU RMP category 1 A pharmacoepidemiological study of rivaroxaban use and potential adverse outcomes in routine clinical practice in Sweden Yes Yes
9977 Finalised EU RMP category 1 An Observational Post-authorization Safety Specialist Cohort Event Monitoring Study (SCEM) to Monitor the Safety and Utilization of rivaroxaban... Yes Yes
9991 Finalised EU RMP category 3 Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study Yes Yes
10249 Finalised Not included in RMP BETAPREDICT - MS patients treated with BETAferon®: PREDICTors of treatment adherence Yes Yes
10837 Finalised Not included in RMP A pharmacoepidemiological study on the risk of bleeding in new users of low-dose aspirin (ASA) in The Health Improvement Network (THIN), UK (EPISAT) Yes Yes
11141 Finalised EU RMP category 1 A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands Yes Yes
11145 Finalised EU RMP category 1 A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in Germany Yes Yes
11299 Finalised EU RMP category 1 A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the United Kingdom Yes Yes
12608 Finalised Not included in RMP COSIMO Cancer associated thrombosis - patient reported outcomes with rivaroxaban. A non-interventional study on patients changing to Xarelto® for... Yes Yes
12665 Finalised Not included in RMP Second primary cancers in patients with castration resistant prostate cancer (BOCARP) Yes Yes
13054 Finalised EU RMP category 3 EPID Multiple Sclerosis Pregnancy study - Pregnancy outcomes in Multiple Sclerosis populations exposed and unexposed to interferon beta - a... Yes Yes
13602 Finalised Not included in RMP Incidence of Second Primary Malignancies in Patients With Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US Yes Yes
14567 Finalised Not included in RMP Benefit-Risk Of arterial THrombotic prEvention with Rivaroxaban for atrial fibrillation in daily clinical practice. A French cohort within the... Yes Yes
15459 Finalised Not included in RMP A Multinational Phase IV Study Evaluating “Real World” Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog... Yes Yes
15491 Finalised Not included in RMP Incidence of Second primary Malignancies in prostate Cancer patients with bone metastases – an observational retrospective cohort study in Sweden... Yes Yes
15687 Finalised EU RMP category 3 A prospective observational study conducted in France to describe routine clinical practice for treatment naïve or previously treated patients with... Yes Yes
15755 Finalised Not included in RMP Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists... Yes Yes
15961 Finalised EU RMP category 1 An observational post-authorization Modified Prescription-Event Monitoring safety study to monitor the safety and utilization of rivaroxaban... Yes Yes
18521 Finalised Not included in RMP Pattern of use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation patients in UK general practices Yes Yes
20981 Finalised EU RMP category 3 REFINE: Regorafenib observational study in hepatocellular carcinoma Yes Yes
21253 Finalised Not included in RMP Evaluation of Clinical outcomes among non-valvular atrial fibrillatIon patients with renal dysfunction treated with warfarin or reduced dose... Yes Yes
21800 Finalised Not included in RMP Comparative effectiveness of rivaroxaban and warfarin for stroke prevention in multi-morbid patients with nonvalvular atrial fibrillation Yes Yes
23099 Finalised Non-EU RMP-only Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia Yes Yes
23347 Finalised Not included in RMP Association between the Prevalence of cardiovascular risk factors and new use of testosterone Yes Yes
23407 Finalised Not included in RMP Treatment and outcomes among patients with atrial fibrillation and acute coronary syndrome in Sweden Yes Yes
24270 Finalised Not included in RMP Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with Factor Xa nonvitamin-K oral anticoagulants... Yes Yes
24796 Finalised Not included in RMP URANIS –Data collection in urological centers during treatment with Ra-223 dichloride (Xofigo) within the framework of a non-interventional study... Yes Yes
25089 Finalised Not included in RMP Risk of anaphylactoid reactions of Iopromide after intra-arterial administration (UVIA Study) Yes Yes
26416 Ongoing Not included in RMP Observational Study Evaluating Effectiveness and Safety of Real-World Treatment with Damoctocog alfa pegol in Previously Treated Patients with... Yes No
26922 Finalised Not included in RMP Risk association of orofacial cleft and glucocorticoids exposure during pregnancy: a meta-analysis (GC_OC) Yes No
28126 Finalised Not included in RMP Non-traumatic Haemorrhagic Adverse Events: A Cross-sectional Study in Emergency Departments (HARER) No Yes
28234 Finalised Not included in RMP Safety and Effectiveness of Rivaroxaban and Apixaban compared to warfarin in non-valvular atrial fibrillation patients in the routine clinical... Yes Yes
29848 Finalised Not included in RMP PRostAte Cancer vTe In SwEden: epidemiology and anticoagulation treatment of VTE (PRACTISE) Yes Yes
30727 Finalised EU RMP category 3 Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept Administered by Intravitreal Injection in Europe: A Follow-up... Yes Yes
31146 Ongoing Not included in RMP Epidemiology, treatment and healthcare utilization in patients with diabetes mellitus – a population-based observational study using data from the... No No
31734 Ongoing Not included in RMP Darolutamide Observational Study in non-metastatic castration-resistant prostate cancer patients (DAROL) No No
32136 Ongoing EU RMP category 3 PrOspective Non-interventional study in patients with locally advanced or metastatic TRK fusion cancer treated with larotrectinib (ON-TRK) Yes No
32349 Finalised Not included in RMP Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry (XARENO-Registry) Yes Yes
33167 Ongoing Not included in RMP Real-world evidence for non-valvular atrial fibrillation patients treated with oral anticoagulation in the Nordics (REATTAIN) Yes No
33448 Finalised EU RMP category 1 PRECISE/Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium-223 in routine... Yes Yes
33461 Finalised Non-EU RMP-only Study on the association of uterine perforation and intrauterine device (IUD) expulsion with breastfeeding status at the time of IUD insertion and... Yes Yes
33520 Ongoing EU RMP category 1 Observational study evaluating long-term safety of real-world treatment with damoctocog alfa pegol in previously treated patients with hemophilia A... Yes No
33537 Finalised Not included in RMP Adverse ReNal OuTcomEs in patients with NoN-Valvular Atrial fibrillation treated with Rivaroxaban or Vitamin K Antagonists (ANTENNA) Yes Yes
33562 Finalised Not included in RMP Incidence and Trend of Ectopic Pregnancy 2009-2018 - A population-based Study Yes Yes
36102 Finalised Not included in RMP Real-world comparative effectiveness of rivaroxaban versus heparin and phenprocoumon for the treatment and secondary prevention of venous... Yes Yes
36634 Finalised Not included in RMP RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health... Yes Yes
37163 Finalised EU RMP category 3 Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT) Yes Yes
37597 Finalised Not included in RMP Safety profile of Ultravist in children and elderly (UV Age) Yes Yes
38736 Planned EU RMP category 3 INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden Yes No
39592 Ongoing Not included in RMP Effectiveness and safety of non-vitamin K anticoagulants (NOACs) versus warfarin in frail patients with nonvalvular atrial fibrillation (AF): a... No No
41194 Finalised EU RMP category 3 Study to Evaluate Physician Awareness and Knowledge of Safety and Safe Use Information for Androcur and Other Cyproterone Acetate Monotherapies in... Yes Yes
43329 Finalised Not included in RMP Observational Studies in Cancer Associated Thrombosis for Rivaroxaban – United Kingdom Cohort (OSCAR—UK) Yes Yes
43355 Finalised Not included in RMP Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE) Yes Yes
46493 Ongoing Not included in RMP FINE-REAL: Non-interventional study to collect real-world data and providing insights into the use of finerenone in routine clinical practice Yes No
46800 Planned EU RMP category 3 Xarelto Paediatric VTE PASS Drug Utilization Study: An observational, longitudinal, multi-source drug utilization safety study to evaluate the drug... Yes No
47805 Finalised Not included in RMP Safety profile of Ultravist in patients with different sexes, races and from different countries/regions Yes Yes
48148 Ongoing Not included in RMP FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic... Yes No
105067 Ongoing Not included in RMP Effectiveness and safety of low dose rivaroxaban plus aspirin in patients with Chronic Coronary Syndrome and high ischemic risk. (Dutch CCS Registry) No No

PAS by Risk Management Plan (RMP) requirement

Bayer

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.