Bristol-Myers Squibb (BMS)

This sponsor has funded 39 studies across 25 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
2723 Finalised EU RMP category 3 A Multi-National, Prospective, Observational Study in Patients with Unresectable or Metastatic Melanoma (IMAGE) No No
4700 Finalised Not included in RMP Risk of stroke and other cardiovascular events among warfarin-treated atrial fibrillation patients – a nationwide cohort study in Finland (FinWAF) Yes Yes
4924 Finalised Not included in RMP YERVOY Risk Minimisation Tool Evaluation Survey No No
5177 Finalised Not included in RMP POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN Yes Yes
5184 Finalised Not included in RMP POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN THE NETHERLANDS Yes Yes
6033 Finalised EU RMP category 1 Ipilimumab 12-month intensive pharmacovigilance protocol No No
8718 Finalised Not included in RMP Post-marketing Study Assessing the Long-term Safety of Abatacept No No
10046 Finalised Not included in RMP Evaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in European Economic Area... No No
10122 Finalised EU RMP category 3 Evaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid... No Yes
10443 Finalised EU RMP category 3 Evaluation of the effectiveness of Eliquis® (apixaban) risk minimization tools in European No No
10691 Finalised Not included in RMP Disease progression and resource utilization in treated relapse/refractory multiple myeloma in Spain (PREMIERE) No No
11313 Finalised Not included in RMP Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims... Yes No
11521 Finalised Not included in RMP Benefit and risk of AntiThrombotic Treatments after Orthopaedic Surgery in real-life settings: a cohort study in the SNIIRAM claims and... No No
14071 Ongoing EU RMP category 3 Pattern of Use and Safety/Effectiveness of Nivolumab in Routine Oncology Practice (CA209234) No No
14786 Finalised Not included in RMP Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark Yes Yes
18323 Finalised Not included in RMP Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation – effectiveness... Yes Yes
18444 Ongoing Not included in RMP OBSERVATIONAL COHORT STUDY TO CHARACTERIZE THE SAFETY OF ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (HCT) FOR PATIENTS WITH CLASSICAL HODGKIN... No No
18596 Finalised Not included in RMP A Global Enhanced Pharmacovigilance Pregnancy Surveillance Study of Pregnant Women Exposed to Yervoy® with 5-year Pediatric Follow-up (CA184-487) No No
20861 Planned Not included in RMP Retrospective Chart Review Study of First-Line Treatment Patterns and Clinical Outcomes in Patients with Advanced (Unresectable or Metastatic)... No No
25305 Finalised Not included in RMP Real-world Evidence of Prolonged Apixaban Treatment of Unprovoked Venous Thromboembolism Yes Yes
25308 Finalised Not included in RMP Evaluation of Anticoagulants among Venous Thromboembolism Patients with Active Cancer: Pooled Analysis from Claims Databases Yes Yes
25405 Ongoing Not included in RMP Comparative safety of abatacept in rheumatoid arthritis with COPD: A real-world population-based observational study No No
25626 Ongoing Not included in RMP Long-term non-interventional monitoring of patients newly diagnosed with bronchogenic carcinoma (LUCAS) No No
29722 Ongoing EU RMP category 3 Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR) No No
29910 Ongoing Not included in RMP Venous Thromboembolism Treatment (VOLT) No No
29920 Planned Not included in RMP Preferences of patients and oncologists for the characteristics of the treatment for RCC in Spain and Portugal No No
30299 Planned Not included in RMP INVESTIGATING SECULAR TRENDS IN THE SURVIVAL OF MELANOMA PATIENTS IN ENGLAND Yes No
31529 Ongoing EU RMP category 3 A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Sweden Using the SRQ Register No No
31532 Ongoing EU RMP category 3 A Nationwide Post-Marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register No No
32365 Finalised Not included in RMP Evaluation of the Safety and Effectiveness of Anticoagulants Among Sub-Groups of Venous Thromboembolism Patients (VTE Subgroups) Yes Yes
35888 Ongoing Not included in RMP Anticoagulant treatment patterns and outcomes among venous thrombosis patients in France: a retrospective cohort analysis using SNDS database No No
44059 Ongoing Not included in RMP OPTIMISE:MS A Prospective, Real World Pharmacovigilance Study in Multiple Sclerosis Yes No
44615 Ongoing EU RMP category 3 ORION (Ozanimod Real-World Safety - A Post-Authorisation Multi-National Long-term Non-Interventional Study) No No
45152 Ongoing EU RMP category 1 Non-interventional Post-authorization Safety Study (PASS) of Patients Treated with Idecabtagene Vicleucel (ide-cel, BB2121) for Multiple Myeloma (MM)... Yes No
103852 Planned EU RMP category 1 Non-interventional, post-authorization efficacy study to assess the consistency of Breyanzi product quality and clinical outcomes in patients treated... Yes No
103855 Ongoing EU RMP category 1 Non-interventional, post-authorization safety study (PASS) of patients treated with commercially available liso-cel (lisocabtagene maraleucel) for... Yes No
104661 Planned Not included in RMP Immunological adverse effects of immune checkpoint inhibitors (ICIMMUN) No No
107906 Planned EU RMP category 3 Long-term follow-up of pediatric patients exposed to nivolumab + relatlimab fixed-dose combination (FDC) enrolled in the Dutch Melanoma Treatment... No No
108178 Planned EU RMP category 3 Mavacamten Real-World Safety: a post-authorisation multi-national, long-term, observational study in patients with obstructive Hypertrophic... No No

PAS by Risk Management Plan (RMP) requirement

Bristol-Myers Squibb (BMS)

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.