Abstract 1003: Application of the International Society on Thrombosis and Haemostasis (ISTH) Definition of Major Bleeds To Bleeding Events Within a Post Authorization Safety Study
Haemorrhage is a frequent complication of anticoagulant (AC) use. In order to compare incidencesbetween trials a definition of major bleeds (MB) in non surgical studies was developed by the InternationalSociety on Thrombosis and Haemostasis (ISTH) in 2005.
Abstract 821: Reasons for and Time To Antipsychotic (AP) Treatment Discontinuation: Results from a Post-Authorisation Safety Study
APs are generally effective but some patients (pts) may stop soon after starting due to poor tolerability.
Abstract 814: Defining Risk Profiles in Special Populations -Results from a Post Authorisation Safety Study (PASS) of Seroquel XL Conducted in Primary Care in England
A Risk Management Plan developed for quetiapine extended release (Seroquel XL©), included a PASS to examine its safety and use as prescribed in primary care.
Abstract 582: Observational Assessment of Safety in Seroquel (OASIS) Rates & Patterns of Common Events Observed in Users of Quetiapine Extended-Release (Seroquel XL) and Immediate Release (IR)
Background:The aim of OASIS (ENCePP Study reg.5412) was to extend the post-authorisation safety knowledge of quetiapine XL, with a focus on short-term (12-week (w)) safety and high dose (>600mg/day) use, as prescribed by psychiatrists in patients (pts) with Schizophrenia (Schiz) or Bipolar Disorder (BD), vs quetiapine IR. Study objectives incl. quantifying event incidence and pattern.
Abstract 308: New Methodology for Enhanced Safety Surveillance of Nasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Using Participant Questionnaire Feedback: Interim Results
An active surveillance study was performed at the start of the 2014/2015 influenza season following publication of EMA guidance for enhanced safety surveillance of influenza vaccines.
Abstract 295: Applying the Ready Reckoner (RRec) Tool for Assessing Antipsychotic (AP) Prescribing Within Post-Authorisation Safety Studies (PASS)
In the UK, the RRec monitors AP dosing in patients (pts) with complex AP regimens – each AP dose is converted to % of relevant max dose by indication and titration stage in SPC.
Abstract 266: Antipsychotic (AP) Use in Older Adults With Dementia: Results from a Post-Authorisation Safety Study (PASS)
The UK National Institute for Health and Care Excellence recommends that APs can be used in elderly patients (pts) under strict guidelines, however use is associated with serious safety concerns (incl cerebrovascular accidents (CVA)).
Abstract 217: Use of Antipsychotics (AP) in Mental Health Secondary Care Setting Vs Primary Care
Safety studies conducted exclusively in the primary care setting may be subject to bias because of exclusion of patients (pts) who are managed predominantly within secondary care.
Abstract 151: Utilisation of Asenapine in the Mental Health Care Setting in England and Wales: First Results from a Specialist Cohort Event Monitoring (SCEM) Study
OBSERVA is a SCEM study being conducted as part of the EU Risk Management Plan to monitor the short-term safety and utilisation of asenapine prescribed to new user patients (pts) by psychiatrists in the mental health care setting in England and Wales.
Abstract 147: Utilisation of a New Once Weekly Injection for Type 2 Diabetes Mellitus (T2DM): Interim Results from an Observational Cohort Study of Exenatide (Bydureon®) in England
Bydureon® is indicated for the treatment (Rx) of T2DM in combination with metformin, sulphonylurea (SU), thiazolidindione (TZD) alone, metformin & SU or metformin & TZD for patients (pts) who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies alone.