Daiichi Sankyō

This sponsor has funded 13 studies across 16 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3177 Finalised Unspecified SEVIKAR HCT - treatment opportunity for patients with essential hypertension (SeviTarget) No Yes
5911 Finalised EU RMP category 3 Prasugrel Treatment Patterns in Outpatient Settings in Germany, the United Kingdom, and France (H7T-MC-B011) No Yes
5924 Finalised EU RMP category 3 Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel and Prasugrel during the Index Hospitalisation in Germany... No Yes
5934 Finalised EU RMP category 3 Treatment Patterns and Bleeding Risks Comparison in Patients Treated with Clopidogrel or Prasugrel during the Index Hospitalisation in Sweden... No Yes
5972 Finalised EU RMP category 3 Treatment patterns in acute myocardial infarction patients initiated with prasugrel or clopidogrel during the index hospitalisation with one year... No Yes
6355 Finalised EU RMP category 3 Assessment of the effectiveness of risk minimisation measures set up for new safety information for Efient® (Prasugrel): a multinational survey among... Yes No
8896 Ongoing EU RMP category 3 Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation (ETNA-AF-Europe) No No
9938 Finalised Unspecified Comparison Of Clinical Outcomes, Resource Utilisation, And Costs In Patients Hospitalized For ACS Managed With PCI And Receiving Prasugrel Or... Yes No
11765 Finalised EU RMP category 1 Evaluation of the Effectiveness of Risk Minimisation Measures: A Joint PASS Survey among Health Care Professionals to Assess their Knowledge and... Yes Yes
15504 Ongoing EU RMP category 3 Non-interventional study on Edoxaban treatment in routine clinical practice in patients with venous thromboembolism Yes No
17062 Ongoing Not included in RMP Edoxaban prescription patterns in Europe: a retrospective drug utilisation chart review study (ETNA-DUS) Yes No
28224 Finalised Not included in RMP Adherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants (QD versus BID DOACs) Yes Yes
46367 Planned EU RMP category 3 Health Care Professional survey on understanding of key risk minimisation measures related to interstitial lung disease (ILD) / pneumonitis with... Yes No

PAS by Risk Management Plan (RMP) requirement

Daiichi Sankyō

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.