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CPRD StudyPrimary Care PASS Study

Abstract 1090: Changes in Health Parameters Over 12 Months in Users of Once Weekly Exenatide (Bydureon[reg])

Bydureon®, licensed in 2011, is indicated for treatment of type 2 diabetes mellitus (T2DM).

CPRD StudyPrimary Care PASS Study

Abstract 874: Passive Enhanced Safety Surveillance In Children Receiving Fluenz® Tetra Vaccination In England During The Early 2015/2016 Influenza Season

Background: Fluenz® Tetra is a quadrivalent, live attenuated, intranasal, influenza vaccine recommended for use in children vaccinated as part of the seasonal influenza immunisation programme in the UK.

CPRD StudyPrimary Care PASS Study

Abstract 873: Methodological Approaches to Enhanced Safety Surveillance for Seasonal Flu Vaccines: Early Experience in the UK

In 2014, the European Medicines Agency issued draft guidance for enhanced safety surveillance (ESS) on seasonal influenza (flu) vaccines.

CPRD StudyPrimary Care PASS Study

Abstract 700: Risk Management and Specialist Cohort-Event Monitoring [ndash] Responding to Change

It is recognised that there is a paucity of data sources to conduct studies in the EU on hospitalised patients (pts) and those seeing specialists.

CPRD StudyPrimary Care PASS Study

Abstract 504: Use of New Oral Anticoagulants in the Secondary Care Setting vs Primary Care in the UK: Interim Results from Two Post-Authorisation Studies

The Risk Management Plan for rivaroxaban (Riv) included studies on the utilisation and safety monitoring of Riv prescribed in primary care.

CPRD StudyPrimary Care PASS Study

Abstract 339: Characterisation of Baseline Risk Factors for Bleeding Outcomes in Patients with Non-Valvular Atrial Fibrillation (AF) Prescribed Rivaroxaban in Primary Care in England: Interim Results from a Post Authorisation Safety Study (PASS)

Rivaroxaban, first approved in the EU in 2008, is one of the novel oral anticoagulants.

CPRD StudyPrimary Care PASS Study

Abstract 338: Cohort Characteristics and Determinants of Prescribing Rivaroxaban in Primary Care in England: Interim Results from a Post Authorisation Safety Study (PASS)

A UK PASS is being conducted as part of a risk management plan to monitor the safety and use of rivaroxaban (Riv) as prescribed for medical conditions requiring anticoagulation.

CPRD StudyPrimary Care PASS Study

Abstract 337: Factors Associated with Rivaroxaban Prescribing in Specialist Care Setting: Interim Results from the Rivaroxaban Observational Safety Evaluation (ROSE) Study

Increasingly choice of medicines is guided by published guidelines. ROSE is being conducted as part of a risk management plan to monitor short-term (first 3 months) safety and utilisation of rivaroxaban (Riv).

CPRD StudyPrimary Care PASS Study

Abstract 335: The Application of the HAS-BLED Criteria within Post Authorisation Safety Studies to Characterise Anticoagulant New User Patients with Non-Valvular Atrial Fibrillation (AF): Interim Results from a Specialist Cohort Event Monitoring (SCEM) Study

The Rivaroxaban Observational Safety Evaluation (ROSE) SCEM study is being conducted as part of a risk management plan to monitor short-term (first 3 months) safety and utilisation of rivaroxaban (Riv).

CPRD StudyPrimary Care PASS Study

Abstract 290: Utilisation of Once Weekly Exenatide (Bydureon[reg]) for Type 2 Diabetes Mellitus (T2DM): Interim Results from an Observational Cohort Study in England

Bydureon®, licensed in 2011, is indicated for treatment of T2DM in combination with metformin (MET), sulphonylurea (SU), thiazolidinedione (TZD), MET+SU or MET+TZD for patients (pts) with inadequate glycaemic control on maximally tolerated doses of these therapies alone.