Search results for: adverse event

Authors: Kwaku Damoah

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This study presents a comprehensive data-driven analysis to understand the evolution of adverse events (AEs) in pharmacovigilance. Utilizing data from the FDA Adverse Event Reporting System (FAERS), we employed three analytical methods: rank-based, frequency-based, and percentage change analyses. These methods assessed temporal trends and patterns in AE reporting, focusing on various drug-active ingredients and patient demographics. Our findings reveal significant trends in AE occurrences, with both increasing and decreasing patterns from 2000 to 2023. This research highlights the importance of continuous monitoring and advanced analysis in pharmacovigilance, offering valuable insights for healthcare professionals and policymakers to enhance drug safety.

Keywords: event analysis, FDA adverse event reporting system, pharmacovigilance, temporal trend analysis

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Authors: Arne Koschel

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This article discusses event monitoring options for heterogeneous event sources as they are given in nowadays heterogeneous distributed information systems. It follows the central assumption, that a fully generic event monitoring solution cannot provide complete support for event monitoring; instead, event source specific semantics such as certain event types or support for certain event monitoring techniques have to be taken into account. Following from this, the core result of the work presented here is the extension of a configurable event monitoring (Web) service for a variety of event sources. A service approach allows us to trade genericity for the exploitation of source specific characteristics. It thus delivers results for the areas of SOA, Web services, CEP and EDA.

Keywords: event monitoring, ECA, CEP, SOA, web services

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Authors: Nashed Atef Nashed Farag

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Introduction: Reporting adverse events following vaccination remains a challenge. WHO has mandated pharmacovigilance centers around the world to submit Adverse Events Following Immunization (AEFI) reports from different countries to a large electronic database of adverse drug event data called Vigibase. Despite sufficient information about AEFIs on Vigibase, they are not available to the general public. However, the WHO has an alternative website called VigiAccess, an open-access website that serves as an archive for reported adverse reactions and AEFIs. The aim of the study was to establish a reporting model for a number of commonly used vaccines in the VigiAccess system. Methods: On February 5, 2018, VigiAccess comprehensively searched for ESSI reports on the measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine, and tuberculosis vaccine (BCG). These are reports from all pharmacovigilance centers around the world since they joined the WHO Drug Monitoring Program. Results: After an extensive search, VigiAccess found 9,062 AEFIs from the measles vaccine, 185,829 AEFIs from the OPV vaccine, 24,577 AEFIs from the yellow fever vaccine, 317,208 AEFIs from the pneumococcal vaccine, 73,513 AEFIs from the rotavirus vaccine, and 145,447 AEFIs from meningococcal cal vaccine, 22,781 EI FI vaccines against tetanus and 35,556 BCG vaccines against AEFI. Conclusion: The study found that among the eight vaccines examined, pneumococcal vaccines were associated with the highest number of AEFIs, while measles vaccines were associated with the fewest AEFIs.

Keywords: surgical approach, anatomical approach, decompression, axillary nerve, quadrangular space adverse events following immunization, cameroon, COVID-19 vaccines, nOPV, ODK vaccines, adverse reactions, VigiAccess, adverse event reporting

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Authors: Mareen Brosterhaus, Antje Hammer, Steffen Kalina, Stefan Grau, Anjali A. Roeth, Hany Ashmawy, Thomas Gross, Marcel Binnebosel, Wolfram T. Knoefel, Tanja Manser

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Background: The identification of critical incidents in hospitals is an essential component of improving patient safety. To date, various methods have been used to measure and characterize such critical incidents. These methods are often viewed by physicians and nurses as external quality assurance, and this creates obstacles to the reporting events and the implementation of recommendations in practice. One way to overcome this problem is to use tools that directly involve staff in measuring indicators of quality and safety of care in the department. One such instrument is the global trigger tool (GTT), which helps physicians and nurses identify adverse events by systematically reviewing randomly selected patient records. Based on so-called ‘triggers’ (warning signals), indications of adverse events can be given. While the tool is already used internationally, its implementation in German hospitals has been very limited. Objectives: This study aimed to assess the feasibility and potential of the global trigger tool for identifying adverse events in German hospitals. Methods: A total of 120 patient records were randomly selected from two surgical, and one neurosurgery, departments of three university hospitals in Germany over a period of two months per department between January and July, 2017. The records were reviewed using an adaptation of the German version of the Institute for Healthcare Improvement Global Trigger Tool to identify triggers and adverse event rates per 1000 patient days and per 100 admissions. The severity of adverse events was classified using the National Coordinating Council for Medication Error Reporting and Prevention. Results: A total of 53 adverse events were detected in the three departments. This corresponded to adverse event rates of 25.5-72.1 per 1000 patient-days and from 25.0 to 60.0 per 100 admissions across the three departments. 98.1% of identified adverse events were associated with non-permanent harm without (Category E–71.7%) or with (Category F–26.4%) the need for prolonged hospitalization. One adverse event (1.9%) was associated with potentially permanent harm to the patient. We also identified practical challenges in the implementation of the tool, such as the need for adaptation of the global trigger tool to the respective department. Conclusions: The global trigger tool is feasible and an effective instrument for quality measurement when adapted to the departmental specifics. Based on our experience, we recommend a continuous use of the tool thereby directly involving clinicians in quality improvement.

Keywords: adverse events, global trigger tool, patient safety, record review

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Authors: Pankaj Prashar, Bimlesh Kumar, Ankita Sood, Anamika Gautam

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Pharmacovigilance (PV) is a rapidly growing discipline in pharmaceutical industries as an integral part of clinical research and drug development over the past few decades. PV carries a breadth of scope from drug manufacturing to its regulation with safer utilization. The fundamental steps of PV not only includes data collection and verification, coding of drugs with adverse drug reactions, causality assessment and timely reporting to the authorities but also monitoring drug manufacturing, safety issues, product quality and conduction of due diligence. Standardization of adverse event information, collaboration of multiple departments in different companies, preparation of documents in accordance to both governmental as well as non-governmental organizations (FDA, EMA, GVP, ICH) are the advancements in discipline of PV. De-harmonization, lack of predictive drug safety models, improper funding by government, non-reporting, and non-acceptability of ADRs by developing countries and reports directly from patients to the monitoring centres respectively are the major road backs of PV. Mandatory pharmacovigilance reporting, frequent inspections, funding by government, educating and training medical students, pharmacists and nurses in this segment can bring about empowerment in PV. This area needs to be addressed with a sense of urgency for the safe utilization of pharmaceuticals.

Keywords: pharmacovigilance, regulatory, adverse event, drug safety

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Authors: Kwan Hee Han, Jun Woo Lee, Sung Moon Bae, Twae Kyung Park

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ECA (Event-Condition-Action) languages are largely adopted for event processing since they are an intuitive and powerful paradigm for programming reactive systems. However, there are some limitations about ECA rules for processing of complex events such as coupling of event producer and consumer. The objective of this paper is to propose an ECA rule pattern to improve the current limitations of ECA rule, and to develop a prototype system. In this paper, conventional ECA rule is separated into 3 parts and each part is extended to meet the requirements of CEP. Finally, event processing logic is established by combining the relevant elements of 3 parts. The usability of proposed extended ECA rule is validated by a test scenario in this study.

Keywords: complex event processing, ECA rule, Event processing system, event-driven architecture, internet of things

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Authors: Anam Alam, Rahim Jamaluddin Kanji

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With the rapid growth of event in everywhere, event extraction has now become an important matter to retrieve the information from the unstructured data. One of the challenging problems is to extract the event from it. An event is an observable occurrence of interaction among entities. The paper investigates the effectiveness of event extraction capabilities of three software tools that are Wandora, Nitro and SPSS. We performed standard text mining techniques of these tools on the data sets of (i) Afghan War Diaries (AWD collection), (ii) MUC4 and (iii) WebKB. Information retrieval measures such as precision and recall which are computed under extensive set of experiments for Event Extraction. The experimental study analyzes the difference between events extracted by the software and human. This approach helps to construct an algorithm that will be applied for different machine learning methods.

Keywords: event extraction, Wandora, nitro, SPSS, event analysis, extraction method, AFG, Afghan War Diaries, MUC4, 4 universities, dataset, algorithm, precision, recall, evaluation

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Authors: Pranee Suecharoen, Ratchadaporn Soontornpas, Jaturat Kanpittaya

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Background: Contrast media has an important role for disease diagnosis through detection of pathologies. Contrast media can, however, cause adverse reactions after administration of its agents. Although non-ionic contrast media are commonly used, the incidence of adverse events is relatively low. The most common reactions found (10.5%) were mild and manageable and/or preventable. Pharmacists can play an important role in evaluating adverse reactions, including awareness of the specific preparation and the type of adverse reaction. As most common types of adverse reactions are idiosyncratic or pseudo-allergic reactions, common standards need to be established to prevent and control adverse reactions promptly and effectively. Objective: To measure the effect of using tools for symptom evaluation in order to reduce the severity, or prevent the occurrence, of adverse reactions from contrast media. Methods: Retrospective review descriptive research with data collected on adverse reactions assessment and Naranjo’s algorithm between June 2015 and May 2016. Results: 158 patients (10.53%) had adverse reactions. Of the 1,500 participants with an adverse event evaluation, 137 (9.13%) had a mild adverse reaction, including hives, nausea, vomiting, dizziness, and headache. These types of symptoms can be treated (i.e., with antihistamines, anti-emetics) and the patient recovers completely within one day. The group with moderate adverse reactions, numbering 18 cases (1.2%), had hypertension or hypotension, and shortness of breath. Severe adverse reactions numbered 3 cases (0.2%) and included swelling of the larynx, cardiac arrest, and loss of consciousness, requiring immediate treatment. No other complications under close medical supervision were recorded (i.e., corticosteroids use, epinephrine, dopamine, atropine, or life-saving devices). Using the guideline, therapies are divided into general and specific and are performed according to the severity, risk factors and ingestion of contrast media agents. Patients who have high-risk factors were screened and treated (i.e., prophylactic premedication) for prevention of severe adverse reactions, especially those with renal failure. Thus, awareness for the need for prescreening of different risk factors is necessary for early recognition and prompt treatment. Conclusion: Studying adverse reactions can be used to develop a model for reducing the level of severity and setting a guideline for a standardized, multidisciplinary approach to adverse reactions.

Keywords: role of pharmacist, management of adverse reactions, guideline for contrast media, non-ionic contrast media

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Authors: Peter Yamoah, Frasia Oosthuizen

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Introduction: Reporting of Adverse Events Following Immunization continues to be a challenge. Pharmacovigilance centers throughout the world are mandated by the WHO to submit AEFI reports from various countries to a large pool of adverse drug reaction electronic database called Vigibase. Despite the relevant information of AEFI in Vigibase, it is unavailable to the general public. However, the WHO has an alternative website called VigiAccess which is an open access website serving as a repository of reported adverse drug reactions and AEFIs. The aim of the study was to ascertain the reporting pattern of a number of commonly used vaccines in VigiAccess. Methods: VigiAccess was thoroughly searched on the 5th of February 2018 for AEFI reports of measles vaccine, oral polio vaccine (OPV), yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and tuberculosis (BCG) vaccine. These were reports from all pharmacovigilance centers in the world from the time they joined the WHO drug monitoring program. Results: After a thorough search in VigiAccess, there were 9,062 measles vaccine AEFIs, 185,829 OPV AEFIs, 24,577 yellow fever vaccine AEFIs, 317,208 pneumococcal vaccine AEFIs, 73,513 rotavirus vaccine AEFIs, 145,447 meningococcal vaccine AEFIs, 22,781 tetanus vaccine AEFIs and 35,556 BCG vaccine AEFIs. Conclusion: The study revealed that out of the eight vaccines studied, pneumococcal vaccines are associated with the highest number of AEFIs whilst measles vaccines were associated with the least AEFIs.

Keywords: vaccines, adverse reactions, VigiAccess, adverse event reporting

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Authors: Duhania O. Mahara, Santi W. Purnami, Aulia N. Fitria, Merissa N. Z. Wirontono, Revina Musfiroh, Shofi Andari, Sagiran Sagiran, Estiana Khoirunnisa, Wahyudi Widada

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For assessing interventions in numerous disease areas, the use of multiple time-to-event outcomes is common. An individual might experience two different events called bivariate time-to-event data, the events may be correlated because it come from the same subject and also influenced by individual characteristics. The bivariate time-to-event case can be applied by copula-based bivariate Cox survival model, using the Clayton and Frank copulas to analyze the dependence structure of each event and also the covariates effect. By applying this method to modeling the recurrent event infection of hemodialysis insertion on chronic kidney disease (CKD) patients, from the AIC and BIC values we find that the Clayton copula model was the best model with Kendall’s Tau is (τ=0,02).

Keywords: bivariate cox, bivariate event, copula function, survival copula

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Authors: Puntarikorn Rungrattanakasin

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Objectives: To develop the trigger tool to warn about the risk of bleeding as an adverse event from warfarin drug usage during admission in Medical Wards of Chumphae Hospital. Methods: A retrospective study was performed by reviewing the medical records for the patients admitted between June 1st,2020- May 31st, 2021. ADEs were evaluated by Naranjo’s algorithm. The international normalized ratio (INR) and events of bleeding during admissions were collected. Statistical analyses, including Chi-square test and Reciever Operating Characteristic (ROC) curve for optimal INR threshold, were used for the study. Results: Among the 139 admissions, the INR range was found to vary between 0.86-14.91, there was a total of 15 bleeding events, out of which 9 were mild, and 6 were severe. The occurrence of bleeding started whenever the INR was greater than 2.5 and reached the statistical significance (p <0.05), which was in concordance with the ROC curve and yielded 100 % sensitivity and 60% specificity in the detection of a bleeding event. In this regard, the INR greater than 2.5 was considered to be an optimal threshold to alert promptly for bleeding tendency. Conclusions: The INR value of greater than 2.5 (>2.5) would be an appropriate trigger tool to warn of the risk of bleeding for patients taking warfarin in Chumphae Hospital.

Keywords: trigger tool, warfarin, risk of bleeding, medical wards

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Authors: Khaliun Nyambayar, Nomindari Azzaya, Batkhuyag Purevjav

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Pharmacovigilance was officially introduced in Mongolia in 2003, in accordance with the Health Minister Order 183 for the registry of adverse drug reactions (ADR), approved in 2006 and was reviewed in 2010. This study was designed to evaluate the incidence and common types of adverse drug reactions among hospitalized children, the frequency of adverse drug reaction reported by health care providers, and the follow-up processes resulting from adverse drug reactions. A retrospective study of paediatric patients who experienced an adverse drug reaction from 2015 to 2019, extracted from the “yellow” card at the State Research Center for Maternal and Child Health, (city). A total of 417 adverse drug reactions were reported with an overall incidence was 80 (21.5%). Adverse reactions resulting from the use of antibiotics (particularly gentamycin, cephalosporins, and vancomycin) were usually mild. ADR’s were reported by physicians and nurses (93.8%), pharmacists (6.25%). Although documentation of physician notification occurred for 93% of adverse drug reactions, only 29% of cases were documented in the patient's medical chart, 13% included follow-up education for individuals involved, and 10% were updated in the allergy profile of the hospital computer system. Measures to improve the detection and reporting of adverse drug reactions by all health care professionals should be improved, to enhance our understanding of the nature and impact of these reactions in children.

Keywords: adverse drug reaction, pediatric, yellow card, Mongolia

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Authors: Mohsin Raza, Arne Bilberg, Thomas Ditlev Brunø, Ann-Louise Andersen, Filip SKärin

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Shifting from a dedicated or flexible manufacturing system to a reconfigurable manufacturing system (RMS) requires a significant amount of time, money, and effort. Therefore, it is vital to verify beforehand that the potential reconfigurable solution will be able to achieve the organizational objectives. Discrete event simulation offers the opportunity of assessing several reconfigurable alternatives against the set objectives. This study signifies the importance of using discrete-event simulation as a tool to verify several reconfiguration options. Two different industrial cases have been presented in the study to elaborate on the role of discrete event simulation in the implementation methodology of RMSs. The study concluded that discrete event simulation is one of the important tools to consider in the RMS implementation methodology.

Keywords: reconfigurable manufacturing system, discrete event simulation, Tecnomatix plant simulation, RMS

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Authors: Rajaa Filali, Mohamed Bouhdadi

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This paper presents an incremental formal development of the Wireless Transaction Protocol (WTP) in Event-B. WTP is part of the Wireless Application Protocol (WAP) architectures and provides a reliable request-response service. To model and verify the protocol, we use the formal technique Event-B which provides an accessible and rigorous development method. This interaction between modelling and proving reduces the complexity and helps to eliminate misunderstandings, inconsistencies, and specification gaps. As result, verification of WTP allows us to find some deficiencies in the current specification.

Keywords: event-B, wireless transaction protocol, proof obligation, refinement, Rodin, ProB

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Authors: Rajaa Filali, Mohamed Bouhdadi

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This paper presents an incremental development of the Dynamic Host Configuration Protocol (DHCP) in Event-B. DHCP is widely used communication protocol, which provides a standard mechanism to obtain configuration parameters. The specification is performed in a stepwise manner and verified through a series of refinements. The Event-B formal method uses the Rodin platform to modeling and verifying some properties of the protocol such as safety, liveness and deadlock freedom. To model and verify the protocol, we use the formal technique Event-B which provides an accessible and rigorous development method. This interaction between modelling and proving reduces the complexity and helps to eliminate misunderstandings, inconsistencies, and specification gaps.

Keywords: DHCP protocol, Event-B, refinement, proof obligation, Rodin

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Authors: Sabrine Ammar, Mohamed Tahar Bhiri

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Automatic planning has a de facto standard language called Planning Domain Definition Language (PDDL) for describing planning problems. It aims to formalize the planning problems described by the concept of state space. PDDL-related dynamic analysis tools, namely planners and validators, are insufficient for verifying and validating PDDL descriptions. Indeed, these tools made it possible to detect errors a posteriori by means of test activity. In this paper, we recommend a formal approach coupling the two languages Event-B and PDDL, for automatic planning. Event-B is used for formal modeling by stepwise refinement with mathematical proofs of planning problems. Thus, this paper proposes a refinement strategy allowing to obtain reliable PDDL descriptions from an ultimate Event-B model correct by construction. The ultimate Event-B model, correct by construction which is supposed to be translatable into PDDL, is automatically translated into PDDL using our MDE Event-B2PDDL tool.

Keywords: code generation, event-b, PDDL, refinement strategy, translation rules

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Authors: Yufen Qin

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Topic-to-Essay generation is a challenging task in Natural language processing, which aims to generate novel, diverse, and topic-related text based on user input. Previous research has overlooked the generation of articles under the constraints of event elements, resulting in issues such as incomplete event elements and logical inconsistencies in the generated results. To fill this gap, this paper proposes an event-constrained approach for a topic-to-essay generation that enforces the completeness of event elements during the generation process. Additionally, a language model is employed to verify the logical consistency of the generated results. Experimental results demonstrate that the proposed model achieves a better BLEU-2 score and performs better than the baseline in terms of subjective evaluation on a real dataset, indicating its capability to generate higher-quality topic-related text.

Keywords: event element, language model, natural language processing, topic-to-essay generation.

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Authors: Yi-De Liu

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Cultural tourism is one of the largest and fastest growing global tourism markets and the cultures are increasingly being used to promote cities and to increase their competitiveness and attractiveness. One of the major forms of cultural tourism development undertaken throughout Europe has been the staging of a growing number of cultural events. The event of European Capitals of Culture (ECOC) is probably the best example of the new trends of cultural tourism in Europe, which is therefore used in this article to demonstrate some of the key issues surrounding the event-led strategy for cultural tourism development. Based on the experience of the 2008 ECOC Liverpool, UK, the study’s findings point to a number of ways in which the ECOC constitutes a boost for the development of cultural tourism in terms of realising experience economy, enhancing city image, facilitating urban regeneration, promoting cultural production and consumption, as well as establishing partnerships. This study is concluded by drawing some critical factors that event and tourism organisers should consider.

Keywords: cultural tourism, event tourism, cultural event, European capital of culture, Liverpool

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Authors: Nisa Mohan

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Clinical coding is a feasible method for estimating the national prevalence of adverse drug event (ADE) admissions. However, under-coding of ADE admissions is a limitation of this method. Whilst the under-coding will impact the accurate estimation of the actual burden of ADEs, the feasibility of the coded data in estimating the adverse drug event admissions goes much further compared to the other methods. Therefore, it is necessary to know the reasons for the under-coding in order to improve the clinical coding of ADE admissions. The ability to identify the reasons for the under-coding of ADE admissions rests on understanding the decision-making process of coding ADE admissions. Hence, the current study aimed to explore the decision-making process of clinical coders when coding cases of ADE admissions. Clinical coders from different levels of coding job such as trainee, intermediate and advanced level coders were purposefully selected for the interviews. Thirteen clinical coders were recruited from two Auckland region District Health Board hospitals for the interview study. Semi-structured, one-on-one, face-to-face interviews using open-ended questions were conducted with the selected clinical coders. Interviews were about 20 to 30 minutes long and were audio-recorded with the approval of the participants. The interview data were analysed using a general inductive approach. The interviews with the clinical coders revealed that the coders have targets to meet, and they sometimes hesitate to adhere to the coding standards. Coders deviate from the standard coding processes to make a decision. Coders avoid contacting the doctors for clarifying small doubts such as ADEs and the name of the medications because of the delay in getting a reply from the doctors. They prefer to do some research themselves or take help from their seniors and colleagues for making a decision because they can avoid a long wait to get a reply from the doctors. Coders think of ADE as a small thing. Lack of time for searching for information to confirm an ADE admission, inadequate communication with clinicians, along with coders’ belief that an ADE is a small thing may contribute to the under-coding of the ADE admissions. These findings suggest that further work is needed on interventions to improve the clinical coding of ADE admissions. Providing education to coders about the importance of ADEs, educating clinicians about the importance of clear and confirmed medical records entries, availing pharmacists’ services to improve the detection and clear documentation of ADE admissions, and including a mandatory field in the discharge summary about external causes of diseases may be useful for improving the clinical coding of ADE admissions. The findings of the research will help the policymakers to make informed decisions about the improvements. This study urges the coding policymakers, auditors, and trainers to engage with the unconscious cognitive biases and short-cuts of the clinical coders. This country-specific research conducted in New Zealand may also benefit other countries by providing insight into the clinical coding of ADE admissions and will offer guidance about where to focus changes and improvement initiatives.

Keywords: adverse drug events, clinical coders, decision making, hospital admissions

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Authors: Humraaz Kaja, Kofi Mensah, Frasia Oosthuizen

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Background and Aim: Vilazodone was approved in 2011 as an antidepressant to treat the major depressive disorder. As a relatively new drug, it is not clear if all adverse effects have been identified. The aim of this study was to review the adverse effects reported to the WHO Programme for International Drug Monitoring (PIDM) in order to add to the knowledge about the safety profile and adverse effects caused by vilazodone. Method: Data on adverse effects reported for vilazodone was obtained from the database VigiAccess managed by PIDM. Data was extracted from VigiAccess using Excel® and analyzed using descriptive statistics. The data collected was compared to the patient information leaflet (PIL) of Viibryd® and the FDA documents to determine adverse drug reactions reported post-marketing. Results: A total of 9708 adverse events had been recorded on VigiAccess, of which 6054 were not recorded on the PIL and the FDA approval document. Most of the reports were received from the Americas and were for adult women aged 45-64 years (24%, n=1059). The highest number of adverse events reported were for psychiatric events (19%; n=1889), followed by gastro-intestinal effects (18%; n=1839). Specific psychiatric disorders recorded included anxiety (316), depression (208), hallucination (168) and agitation (142). The systematic review confirmed several psychiatric adverse effects associated with the use of vilazodone. The findings of this study suggested that these common psychiatric adverse effects associated with the use of vilazodone were not known during the time of FDA approval of the drug and is not currently recorded in the patient information leaflet (PIL). Conclusions: In summary, this study found several adverse drug reactions not recorded in documents emanating from clinical trials pre-marketing. This highlights the importance of continued post-marketing surveillance of a drug, as well as the need for further studies on the psychiatric adverse events associated with vilazodone in order to improve the safety profile.

Keywords: adverse drug reactions, pharmacovigilance, post-marketing surveillance, vilazodone

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Authors: Pranee Suecharoen, Jaturat Kanpittaya

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Background: The incidence of adverse reactions to iodinated contrast media has risen. The dearth of reports on reactions to the administration of iso- and low-osmolar contrast media should be addressed. We, therefore, studied the profile of adverse reactions to iodinated contrast media; viz., (a) the body systems affected (b) causality, (c) severity, and (d) preventability. Objective: To study adverse reactions (causes and severity) to iodinated contrast media at Srinagarind Hospital. Method: Between March and July, 2015, 1,101 patients from the Department of Radiology were observed and interviewed for the occurrence of adverse reactions. The patients were classified per Naranjo’s algorithm and through use of an adverse reactions questionnaire. Results: A total of 105 cases (9.5%) reported adverse reactions (57% male; 43% female); among whom 2% were iso-osmolar vs. 98% low-osmolar. Diagnoses included hepatoma and cholangiocarcinoma (24.8%), colorectal cancer (9.5%), breast cancer (5.7%), cervical cancer (3.8%), lung cancer (2.9%), bone cancer (1.9%), and others (51.5%). Underlying diseases included hypertension and diabetes mellitus type 2. Mild, moderate, and severe adverse reactions accounted for 92, 5 and 3%, respectively. The respective groups of escalating symptoms included (a) mild urticaria, itching, rash, nausea, vomiting, dizziness, and headache; (b) moderate hypertension, hypotension, dyspnea, tachycardia and bronchospasm; and (c) severe laryngeal edema, profound hypotension, and convulsions. All reactions could be anticipated per Naranjo’s algorithm. Conclusion: Mild to moderate adverse reactions to low-osmolar contrast media were most common and these occurred immediately after administration. For patient safety and better outcomes, improving the identification of patients likely to have an adverse reaction is essential.

Keywords: adverse reactions, contrast media, computed tomography, iodinated contrast agents

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Authors: Fatin Fadhilah Hasib, Dewi Nuraini, Nisful Laila, Muhammad Madyan

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A big political event such as Cabinet reshuffle mostly can affect the stock price positively or negatively, depend on the perception of each investor and potential investor. This study aims to analyze the movement of the market and trading activities which respect to an event using event study method. This method is used to measure the movement of the stock exchange in which abnormal return can be obtained by investor related to the event. This study examines the differences of reaction on abnormal return and trading volume activity from the companies listed in the Jakarta Islamic Index (JII), before and after the announcement of the Cabinet Work Volume II on 27 July 2016. The study was conducted in observation of 21 days in total which consists of 10 days before the event and 10 days after the event. The method used in this study is event study with market adjusted model method that observes market reaction to the information of an announcement or publicity events. The Results from the study showed that there is no significant negative nor positive reaction at the abnormal return and abnormal trading before and after the announcement of the cabinet reshuffle. It is indicated by the results of statistical tests whose value not exceeds the level of significance. Stock exchange of the JII just reflects from the previous stock prices without reflecting the information regarding to the Cabinet reshuffle event. It can be concluded that the capital market is efficient with a weak form.

Keywords: abnormal return, abnormal trading volume activity, event study, political event

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Authors: Majid Mathlouthi, Fethi Lebdi

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Throughout the world, the extent and magnitude of droughts have economic, social and environmental consequences. Today climate change has become more and more felt; most likely they increase the frequency and duration of droughts. An analysis by event of dry event, from series of observations of the daily rainfall is carried out. A daily precipitation threshold value has been set. A catchment localized in Northern Tunisia where the average rainfall is about 600 mm has been studied. Rainfall events are defined as an uninterrupted series of rainfall days understanding at least a day having received a precipitation superior or equal to a fixed threshold. The dry events are constituted of a series of dry days framed by two successive rainfall events. A rainfall event is a vector of coordinates the duration, the rainfall depth per event and the duration of the dry event. The depth and duration are found to be correlated. So we use conditional probabilities to analyse the depth per event. The negative binomial distribution fits well the dry event. The duration of the rainfall event follows a geometric distribution. The length of the climatically cycle adjusts to the Incomplete Gamma. Results of this analysis was used to study of the effects of climate change on water resources and crops and to calibrate precipitation models with little rainfall records. In response to long droughts in the basin, the drought management system is based on three phases during each of the three phases; different measurements are applied and executed. The first is before drought, preparedness and early warning; the second is drought management, mitigation in the event of drought; and the last subsequent drought, when the drought is over.

Keywords: dry spell, precipitation threshold, climate vulnerability, adaptation measures

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Authors: Jun Sung Go, Jong Kang Park, Jong Tae Kim

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As semi-conductor manufacturing technology evolves; the single event transient problem becomes more significant issue. Single event transient has a critical impact on both combinational and sequential logic circuits, so it is important to evaluate the soft error tolerance of the circuits at the design stage. In this paper, we present a soft error detecting simulation using scan chain. The simulation model generates a single event transient randomly in the circuit, and detects the soft error during the execution of the test patterns. We verified this model by inserting a scan chain in an 8051 microprocessor using 65 nm CMOS technology. While the test patterns generated by ATPG program are passing through the scan chain, we insert a single event transient and detect the number of soft errors per sub-module. The experiments show that the soft error rates per cell area of the SFR module is 277% larger than other modules.

Keywords: scan chain, single event transient, soft error, 8051 processor

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Authors: Shaban Guma, Naim Bajcinca

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We propose an event-triggered algorithm for the solution of a distributed optimization problem by means of the projected subgradient method. Thereby, we invoke an OFDMA resource allocation scheme by applying an event-triggered sensitivity analysis at the access point. The optimal resource assignment of the subcarriers to the involved wireless nodes is carried out by considering the sensitivity analysis of the overall objective function as defined by the control of vehicle clusters with respect to the information exchange between the nodes.

Keywords: consensus, cross-layer, distributed, event-triggered, multi-vehicle, protocol, resource, OFDMA, wireless

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Authors: Meena Kumari, Ajitha Sharma, Mohan Babu Amberkar, Hasitha Manohar, Joseph Thomas, K. L. Bairy

Abstract:

Aim: To evaluate the pattern of occurrence of adverse drug reactions (ADRs) with platinum compounds in cancer chemotherapy at a tertiary care hospital. Methods: It was a retrospective, descriptive case record study done on patients admitted to the medical oncology ward of Kasturba Hospital, Manipal from July to November 2012. Inclusion criteria comprised of patients of both sexes and all ages diagnosed with cancer and were on platinum compounds, who developed at least one adverse drug reaction during or after the treatment period. CDSCO proforma was used for reporting ADRs. Causality was assessed using Naranjo Algorithm. Results: A total of 65 patients was included in the study. Females comprised of 67.69% and rest males. Around 49.23% of the ADRs were seen in the age group of 41-60 years, followed by 20 % in 21-40 years, 18.46% in patients over 60 years and 12.31% in 1-20 years age group. The anticancer agents which caused adverse drug reactions in our study were carboplatin (41.54%), cisplatin (36.92%) and oxaliplatin (21.54%). Most common adverse drug reactions observed were oral candidiasis (21.53%), vomiting (16.92%), anaemia (12.3%), diarrhoea (12.3%) and febrile neutropenia (0.08%). The results of the causality assessment of most of the cases were probable. Conclusion: The adverse effect of chemotherapeutic agents is a matter of concern in the pharmacological management of cancer as it affects the quality of life of patients. This information would be useful in identifying and minimizing preventable adverse drug reactions while generally enhancing the knowledge of the prescribers to deal with these adverse drug reactions more efficiently.

Keywords: adverse drug reactions, platinum compounds, cancer, chemotherapy

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Authors: Weitao Lin

Abstract:

To quickly extract adequate information from large-scale unstructured text data, this paper studies the representation of events in Chinese scenarios and performs the regularized abstraction. It proposes a Chinese event detection technique based on dependency parsing and rule matching. The method first performs dependency parsing on the original utterance, then performs pattern matching at the word or phrase granularity based on the results of dependent syntactic analysis, filters out the utterances with prominent non-event characteristics, and obtains the final results. The experimental results show the effectiveness of the method.

Keywords: natural language processing, Chinese event detection, rules matching, dependency parsing

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Authors: Olajumoke Elizabeth Olawale-Olakunle

Abstract:

This research examined effective event development on the sustainability of tourism in Lagos State. The objectives were to ascertain the implication of effective event development on cost, environmental innovations, opportunity for participants, job creation and working conditions. Also, there was a focus on employee participation and the sustainability of the tourism industry. However, the primary data were obtained via the use of structured questionnaire administered to the selected respondents. Simple random sampling was used to select the respondents, using the Yaro Yame formula. The formulated hypothesis was tested using Analysis of Variance (ANOVA) and Non-parametric chi-square. From the tests conducted, the results showed that effective event development has helped to reduce costs, bring about environmental innovations, offer unique opportunity among event participants, create jobs and promote better working conditions, and the influence it has on employee participation affects the sustainability of the tourism industry. Based on these results, it was concluded that effective event development helps to achieve sustainability in the tourism industry by reducing costs, ensuring efficient use of tourism resources and offers a unique opportunity among event participants. It was, therefore, recommended that events should be developed in such a way that it can help to reduce cost and help leverage the financial burdens of participants and stakeholders, thereby, achieving sustainability in the tourism industry.

Keywords: tourism, hospitality, industry, development

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Authors: Nargess Fasih Mardanloo

Abstract:

The purpose of this study was to identify affecting Stadium factors on branding of sport events in Iran. Research methods was qualitative. Interviews was used to collect data. Research community were experts and elites of sports management, sports events and sports marketing who use theoretical and Snowball sampling, 11 individuals were selected. The results showed, Effective ingredients in the city of the event included: Design and branding stadiums and sport facilities, General welfare in Stadium, Reconstruction of Present sports places.Managers can pay attention to the effective stadium factors. Then they use of the benefits of branding event, such as an increase in interest and media sponsors, ticket sales are able to enjoy the event, and many others.

Keywords: brand, branding of sport event, sports events, stadium, sport management.

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Authors: Yusra Pintaningrum, Ilma Fahira Basyir, Sony Hilal Wicaksono, Vito A. Damay

Abstract:

Background: Coronary artery calcium (CAC) scores play an important role in improving prognostic accuracy and can be selectively used to guide the allocation of statin therapy for atherosclerotic cardiovascular disease outcomes and potentially associated with the occurrence of MACE (Major Adverse Cardiovascular Event) and MI (Myocardial Infarction). Objective: This systematic review and meta-analysis aim to analyze the findings of a study about CAC Score and statin treatment effect on MI and MACE risk. Methods: Search for published scientific articles using the PRISMA (Preferred Reporting, Items for Systematic Reviews and Meta-Analysis) method conducted on PubMed, Cochrane Library, and Medline databases published in the last 20 years on “coronary artery calcium” AND “statin” AND “cardiovascular disease” Further systematic review and meta-analysis using RevMan version 5.4 were performed based on the included published scientific articles. Results: Based on 11 studies included with a total of 1055 participants, we performed a meta-analysis and found that individuals with CAC score > 0 increased risk ratio of MI 8.48 (RR = 9.48: 95% CI: 6.22 – 14.45) times and MACE 2.48 (RR = 3.48: 95% CI: 2.98 – 4.05) times higher than CAC score 0 individual. Statin compared against non-statin treatment showed a statistically insignificant overall effect on the risk of MI (P = 0.81) and MACE (P = 0.89) in an individual with elevated CAC score 1 – 100 (P = 0.65) and > 100 (P = 0.11). Conclusions: This study found that an elevated CAC scores individual has a higher risk of MI and MACE than a non-elevated CAC score individual. There is no significant effect of statin compared against non-statin treatment to reduce MI and MACE in elevated CAC score individuals of 1 – 100 or > 100.

Keywords: coronary artery calcium, statin, cardiovascular disease, myocardial infarction, MACE

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