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References

34th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE), Prague, August 2018

CPRD StudyPrimary Care PASS Study

Abstract 1823: Sources of evidence supporting post-marketing pharmacovigilance regulatory actions since 2012.

Major updates to the European Union (EU) pharmacovigilance (PV) legislation were implemented in July 2012.

CPRD StudyPrimary Care PASS Study

Abstract 2085: Passive enhanced safety surveillance in children receiving Fluenz ® Tetra vaccination in England during the early 2017 influenza season.

Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza vaccine recommended for use in children aged 2 to 17 years vaccination as part of the seasonal influenza immunisation campaign in the UK.

CPRD StudyPrimary Care PASS Study

Abstract 2051: Incidence of Major and Clinically Relevant Non-Major (CRNM) Bleeding in Patients Prescribed Rivaroxaban in Secondary Care: Results from the Rivaroxaban Observational Safety Evaluation (ROSE) Study

The ROSE Specialist Cohort Event Monitoring (SCEM) study was conducted to monitor the safety and use of rivaroxaban for Stroke Prevention in patients (pts) with non-valvular AF (SPAF) and the prevention and/or treatment of Deep Vein Thrombosis and/or Pulmonary Embolism (DVT/PE).

CPRD StudyPrimary Care PASS Study

Abstract 2521: Assessment of initiation dose in patients prescribed rivaroxaban for stroke prevention in non-valvular AF (SPAF) and chronic kidney disease – results from the ROSE (Rivaroxaban Observational Safety Evaluation) study.

Rivaroxaban is used to treat patients with non-valvular AF for the prevention of stroke and systemic embolism.

CPRD StudyPrimary Care PASS Study

Abstract 2516: Characteristics of patients initiated on a reduced dose of rivaroxaban for atrial fibrillation (AF) – results from the ROSE (Rivaroxaban Observational Safety Evaluation) study.

Rivaroxaban is used to treat a range of conditions, including prevention of stroke and systemic embolism in patients with AF.

CPRD StudyPrimary Care PASS Study

Abstract 2082: Distribution of CHA2DS2-VASc scores in patients with atrial fibrillation treated with Rivaroxaban in primary vs. secondary care settings.

Since its incorporation in the European Society of Cardiology guidelines in 2010, the CHA2DS2-VASc score is widely used to characterise the risk of stroke in patients (pts) with atrial fibrillation (AF).

CPRD StudyPrimary Care PASS Study

Abstract 2508: Utilisation and safety of asenapine in secondary care in the UK: Results from the Observational Safety Evaluation of Asenapine (OBSERVA) study.

The OBSERVA specialist cohort event monitoring (SCEM) study, conducted in secondary care in the UK, formed part of an EU risk management plan to monitor the use and short-term safety of asenapine, licensed for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.

CPRD StudyPrimary Care PASS Study

Abstract 2500: Utilisation and safety of asenapine in primary care in England: Results from a PASS.

Asenapine is approved in the EU for the treatment of manic episodes associated with bipolar I disorder in adults.

CPRD StudyPrimary Care PASS Study

Multi-level modelling to investigate factors impacting prescribing variability.

Prescribing guidelines influence treatment choice based on patient (pt) and healthcare system factors.