Adverse events - PowerPoint PPT Presentation


Ticagrelor Monotherapy vs. 12-Month Dual Anti-Platelet Therapy After Coronary Stent Implantation for ACS

The study compares the efficacy of ticagrelor monotherapy after less than 1 month of dual anti-platelet therapy (DAPT) to 12-month ticagrelor-based DAPT in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with drug-eluting stent implantation. The aim is

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Severity Assessment in Adverse Drug Reactions

The concept of severity assessment in adverse drug reactions (ADRs) categorizes the intensity of medical events into mild, moderate, severe, or lethal categories based on the required management steps. Various classification systems such as Karch and Lasagna, as well as modified Hartwig's and Siegel

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Active Tuberculosis Drug Safety Monitoring and Management Training Package 2023

This training package focuses on the safety monitoring and management of active tuberculosis drugs, specifically emphasizing causality assessment in determining adverse reactions. Participants will learn about assessing the likelihood of TB medicines causing adverse events, attributing relationships

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Overview of Serious Adverse Reactions and Transfusion Events

This data compilation covers the reporting trends, breakdown of reports, components issued, and specific types of adverse transfusion reactions experienced within the National Healthcare Organization (NHO) from 2019 to 2022. The information includes statistics on Serious Adverse Events (SAE), Seriou

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Understanding Adverse Events Following Immunization (AEFI)

Adverse Events Following Immunization (AEFI) are medical incidents that occur after immunization, potentially caused by the vaccine, leading to unfavorable symptoms. Pharmacovigilance plays a crucial role in detecting, assessing, and preventing these events. AEFI can impact immunization programs at

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NSFAS Annual Report 2021/22 - Adverse Audit Findings and Resolutions Update

Significant delays affected the compilation of NSFAS Annual Financial Statements for 2021/22, leading to an adverse audit opinion due to material misstatements and limitations in various financial areas. The report highlights issues with amounts owed, receivables, bursaries, cash flows, irregular ex

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Understanding Adverse Events in Clinical Trials

This presentation covers the identification, recording, and reporting of adverse events in clinical trials conducted by University of Edinburgh and/or NHS Lothian. It includes definitions, examples of adverse event recording, SAE form completion, and common mistakes. AEs can range from minor issues

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Understanding Adverse Childhood Experiences (ACEs): Impact and Implications for Practitioners

Delve into the world of Adverse Childhood Experiences (ACEs) and trauma-informed care through a bite-sized session aimed at practitioners. Learn about the various forms of ACEs, their impact on health and well-being, and the implications for those in caring and supportive roles. Discover how ACEs ar

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Association of Renal and Cerebral Near-Infrared Spectroscopy with Adverse Outcomes in Single Ventricle Patients after Stage I Palliation

Study investigates the association between renal and cerebral near-infrared spectroscopy (NIRS) values and low cardiac output syndrome in single ventricle patients post Stage I palliation. Data from infants who underwent surgery between 2010-2019 is analyzed to determine correlations with adverse ou

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Impact of Adverse Childhood Experiences (ACEs) on Individuals and Society

Adverse Childhood Experiences (ACEs) encompass a wide range of traumatic events during childhood that can have long-lasting effects on individuals. These experiences, such as abuse, neglect, and family issues, can significantly increase the risk of developing harmful behaviors and health conditions

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Understanding Medication Errors in Pharmacovigilance Centers

Adverse drug reactions resulting from medication errors are a significant concern faced by pharmacovigilance centers. This content discusses the importance of this problem, contributing factors, the relevance to pharmacovigilance centers, and strategies for managing medication errors. It highlights

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Bureau of EMS and Trauma System Secure Online EMS System Overview

The Bureau of EMS and Trauma System offers an online platform that allows the public to search for Emergency Medical Care Technicians (EMCT) by name or certification number. The system provides access to EMCT profiles, including information such as certification status, level, issuance and expiratio

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Understanding the Effects of Trauma on Health: Insights from Trauma-Informed Care Implementation

Individual trauma and adverse childhood experiences can have lasting effects on mental, physical, social, and emotional well-being. The Trauma-Informed Care Implementation Resource Center provides valuable insights on defining trauma, examples of traumatic events, prevalence statistics, and types of

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Understanding Frailty in Geriatric Care

Frailty in older adults is a clinical state of vulnerability with risks for adverse outcomes. It is distinct from old age or morbidity and requires careful identification due to its association with adverse events. Screening for frailty is crucial to target interventions effectively and improve pati

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Understanding the New Jersey Patient Safety Act and Reporting Process

The New Jersey Patient Safety Act, enacted in April 2004, aims to enhance patient safety, minimize adverse events, and improve system/facility performance. It emphasizes confidentiality, promotes a blame-free culture, and encourages evidence-based practices. Healthcare facilities, including ASCs, ar

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**Wisconsin Healthcare-Associated Infections in LTC Coalition: Urine Testing Guidelines**

The Wisconsin Healthcare-Associated Infections in LTC Coalition provides guidelines on when to test and submit urine specimens for testing in long-term care facilities. The focus is on reducing unnecessary urine testing, introducing tools like the UTI Stoplight Tool and the When To Test-Nursing Tool

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Ensuring Safety in Research: Guidelines and Reporting

Safety in research is crucial for protecting participants. This content covers key definitions, safety reporting responsibilities, regulatory guidelines, adverse event monitoring, and definitions related to adverse events in clinical trials. Understanding these aspects is essential for safeguarding

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Association of Renal and Cerebral Near Infrared Spectroscopy with Low Cardiac Output in Single Ventricle Patients

Near-infrared spectroscopy (NIRS) has been studied in infants after Stage I palliation surgery to assess its association with low cardiac output and adverse outcomes. This retrospective study investigated postoperative cerebral and renal NIRS values in infants with single ventricle physiology. Resul

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The CLEAR Trial: Investigating Hypertonic Saline and Carbocisteine in Bronchiectasis

The CLEAR Trial is a 2x2 factorial randomized trial evaluating the effectiveness of hypertonic saline and carbocisteine for airway clearance in bronchiectasis over 52 weeks. Led by Professor Stuart Elborn and Professor Judy Bradley from Queen's University Belfast, the trial focuses on clinical and c

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Safety Considerations and Regulatory Definitions in Drug Evaluation

This presentation by Ramy Abdelrahman, MD, delves into safety considerations, regulatory definitions, and practical responsibilities in drug evaluation. It covers adverse events, suspected adverse reactions, and reporting responsibilities for investigators and sponsors. The content emphasizes making

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Understanding the Notice of Adverse Benefit Determination (NOABD)

The Notice of Adverse Benefit Determination (NOABD) is a crucial document that informs Medi-Cal beneficiaries about decisions regarding their services. It outlines what actions were taken, reasons behind those actions, the beneficiaries' rights, and what they can do next. This notice must be provide

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Adverse Benefit Determination Training for Direct Service Providers

Training session on Notice of Adverse Benefit Determination (NOABD) requirements and templates, including types of NOABDs and steps to complete them. Learn background, purpose, and responsibilities related to issuing NOABDs for Fresno County Mental Health Plan providers.

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Aircraft Banking and Turning Techniques Overview

Aircraft banking and turning involve rolling the aircraft to a predetermined angle of bank while maintaining performance and balance for level, climbing, or descending flight to achieve a predetermined heading. The primary methods for banking include using ailerons to turn the airplane, rudder to ba

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Medium Turns Flight Training Manual Section 9

Learn how to execute medium turns in flight training, changing direction through 360 degrees at a constant rate while maintaining altitude and balance. Understand the principles of lift, adverse yaw, and overbanking performance involved in medium turns, along with techniques to reduce adverse yaw an

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Understanding Adverse Information Reporting in National Security

This detailed content covers the importance of reporting adverse information regarding cleared employees in national security settings. It outlines the impact of adverse information on security clearances, the 13 adjudicative guidelines used in determining eligibility for sensitive duties, NISPOM re

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Understanding Disclosure of Adverse Clinical Events in Healthcare

Exploring the essential elements of disclosing adverse clinical events to patients and families in healthcare settings. It covers why disclosure is crucial, barriers to disclosure, triggers for disclosure, policies and procedures, and the other important aspects related to the disclosure process.

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Comparison of NNRTI vs. NNRTI in SENSE Study

The comparison between Etravirine (ETR) and Efavirenz (EFV) in the SENSE Study showed differences in neuropsychiatric adverse events, treatment response, and patient characteristics. ETR with 2 NRTIs resulted in fewer drug-related adverse events than EFV with 2 NRTIs. ETR also showed better response

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Post Market Surveillance Procedures in Indonesia

Post-market surveillance of medical devices in Indonesia is overseen by the Surveillance Directorate of Medical Device and Household Health Supplies. Manufacturers must adhere to ASEAN guidelines and report adverse events through online systems. The country has specific regulations and requirements

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Stress Ulcer Prophylaxis in ICU - Adverse Reactions Reporting Guidelines

Guidelines for reporting adverse reactions in Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU), including definitions of Adverse Reactions (AR), Serious Adverse Reactions (SAR), Adverse Events (AE), Serious Adverse Events (SAE), SARs in SUP-ICU, and SUSARs. Specific conditions considere

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Yellow Fever: Adverse Reactions and Risks

Yellow fever vaccination can lead to severe adverse reactions like anaphylaxis, neurotropic disease, and viscerotropic disease. These reactions can range from immediate hypersensitivity to rare but serious outcomes such as meningitis and multiple system organ failure. The mortality rate associated w

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CARe Program: Enhancing Communication, Apology, and Resolution in Healthcare

The CARe program focuses on approaching adverse events in healthcare with empathy, emphasizing communication, apology, and resolution. It aims to improve patient outcomes, clinician-patient relationships, and overall healthcare system efficiency by addressing adverse events promptly and transparentl

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Noise Control Measures and Community Preferences at the Corn Exchange

Various images and references discuss the history of amplified music events at the Corn Exchange, noise complaints leading to control methods by the FTC, impacts on events and community preferences post-control, and survey findings on participant demographics, noise effects, and desired public event

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Understanding Skin Sensitisation through Adverse Outcome Pathways (AOP)

The Adverse Outcome Pathway (AOP) for Skin Sensitisation provides a mechanistic framework linking Molecular Initiating Events (MIE) to Adverse Outcomes (AO) through Key Events (KE) and Key Event Relationships (KER). AOPs offer a transparent justification for toxicological predictions and play a vita

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Comprehensive Training Package on Active Tuberculosis Drug Safety Monitoring and Management (aDSM) 2023

This comprehensive training package focuses on active tuberculosis drug safety monitoring and management (aDSM) in 2023. It covers indicators, learning objectives, and essential information for implementing effective drug safety measures in tuberculosis treatment. The presentation emphasizes definin

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Pharmacovigilance Guidelines for Clinical Trials in Bronchiectasis Research

The CLEAR Trial is a 2x2 factorial randomized trial evaluating the effectiveness of hypertonic saline and carbocisteine for airway clearance in bronchiectasis patients. The trial, led by Professor Stuart Elborn and Professor Judy Bradley, focuses on pharmacovigilance activities, adverse event defini

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Understanding Adverse Events and Unanticipated Problems in Clinical Research

Explore the significance of adverse event reporting in clinical research, including definitions of adverse events (AEs) and serious adverse events (SAEs), as well as unanticipated problems (UAPs). Learn about the responsibilities of Investigators, Clinical Research Coordinators (CRCs), and Sponsors

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EHR System Function and Information Model: Manage Allergy, Intolerance, and Adverse Reactions

This document outlines the function to manage patient-specific allergy, intolerance, and adverse reaction lists in an Electronic Health Record system. It covers capturing, maintaining, and viewing allergen information over time, including patient-reported events and provider-verified notations. The

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Switch to ATV/r + 3TC: ATLAS-M Study

The ATLAS-M Study focused on switching to ATV/r + 3TC in participants with specific criteria, aiming to assess non-inferiority compared to ATV/r + 2 NRTIs. Results at W48 indicated a higher proportion free of treatment failure with ATV/r + 3TC, with notable differences in virologic failure rates and

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Brain Oxygen Optimization in Severe TBI: Adverse Events Analysis

This study led by Dr. Robert Silbergleit focuses on adverse events in brain oxygen optimization for severe Traumatic Brain Injury (TBI) patients. It outlines key points for reporting adverse events, discusses relatedness algorithms, and presents scenarios to analyze adverse events occurrence post-en

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ASPIRE Study: Switch to DTG + 3TC Virologic Outcome at W24 and W48

The ASPIRE study evaluated the efficacy of switching to DTG + 3TC in HIV patients with stable triple ART regimens. The primary endpoint was treatment failure proportion at W24, with non-inferiority demonstrated at W48. Virologic outcomes, adverse events, and patient dispositions were reported, with

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