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Event Reports (event + report)
Kinds of Event Reports Selected AbstractsSafety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trialsHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2005James I. Hudson Abstract Objective To examine the safety and tolerability of the antidepressant duloxetine across multiple studies for major depressive disorder (MDD). Method Safety data were integrated from the acute phases of eight double-blind, placebo-controlled trials in which patients were randomized to duloxetine (40,120,mg/d; n,=,1139) or placebo (n,=,777) for up to 9 weeks. This data set included all acute-phase clinical trials that formed the basis of the New Drug Application (United States) or European Union submission package for duloxetine in the treatment of MDD. Two studies included continuation phases in which acute treatment responders received duloxetine or placebo for an additional 26 weeks. Safety assessments included serious adverse event reports, rates of discontinuation, spontaneously reported treatment-emergent adverse events, changes in vital signs and laboratory values, and electrocardiograms. Results The rates of serious adverse events for duloxetine- and placebo-treated patients were 0.3% and 0.6%, respectively (p,=,0.282). Adverse events led to discontinuation in 9.7% of duloxetine-treated patients, compared with 4.2% of patients receiving placebo (p,<,0.001). Treatment-emergent adverse events with an incidence for duloxetine ,,5.0% and significantly greater than placebo were nausea, dry mouth, constipation, insomnia, dizziness, fatigue, somnolence, increased sweating and decreased appetite. Mean changes in blood pressure and heart rate were small, and the incidence of increases above normal ranges was low. Duloxetine-treated patients had a mean decrease in weight of 0.5,kg compared with an increase of 0.2,kg for patients receiving placebo (p,<,0.001). No significant differences were found between duloxetine and placebo in the incidence of potentially clinically significant laboratory values at anytime while on treatment. Conclusion These results are consistent with those obtained previously from smaller pooled data sets, and suggest that duloxetine is safe and well tolerated in patients with MDD. Copyright © 2005 John Wiley & Sons, Ltd. [source] Bisphosphonate-Associated Osteonecrosis of the Jaw: Report of a Task Force of the American Society for Bone and Mineral Research,,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 10 2007Sundeep Khosla (Chair) Abstract ONJ has been increasingly suspected to be a potential complication of bisphosphonate therapy in recent years. Thus, the ASBMR leadership appointed a multidisciplinary task force to address key questions related to case definition, epidemiology, risk factors, diagnostic imaging, clinical management, and future areas for research related to the disorder. This report summarizes the findings and recommendations of the task force. Introduction: The increasing recognition that use of bisphosphonates may be associated with osteonecrosis of the jaw (ONJ) led the leadership of the American Society for Bone and Mineral Research (ASBMR) to appoint a task force to address a number of key questions related to this disorder. Materials and Methods: A multidisciplinary expert group reviewed all pertinent published data on bisphosphonate-associated ONJ. Food and Drug Administration drug adverse event reports were also reviewed. Results and Conclusions: A case definition was developed so that subsequent studies could report on the same condition. The task force defined ONJ as the presence of exposed bone in the maxillofacial region that did not heal within 8 wk after identification by a health care provider. Based on review of both published and unpublished data, the risk of ONJ associated with oral bisphosphonate therapy for osteoporosis seems to be low, estimated between 1 in 10,000 and <1 in 100,000 patient-treatment years. However, the task force recognized that information on incidence of ONJ is rapidly evolving and that the true incidence may be higher. The risk of ONJ in patients with cancer treated with high doses of intravenous bisphosphonates is clearly higher, in the range of 1,10 per 100 patients (depending on duration of therapy). In the future, improved diagnostic imaging modalities, such as optical coherence tomography or MRI combined with contrast agents and the manipulation of image planes, may identify patients at preclinical or early stages of the disease. Management is largely supportive. A research agenda aimed at filling the considerable gaps in knowledge regarding this disorder was also outlined. [source] Systematic review: adverse event reports for oral sodium phosphate and polyethylene glycolALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2009J. BELSEY Summary Background, Screening colonoscopy exposes healthy patients to the risk of serious adverse events associated with bowel preparation. Randomized controlled trials are not an effective method for evaluating this risk. Aim, To search published literature in order to characterize the risk of adverse events associated with oral polyethylene glycol (PEG) or sodium phosphate (NaP). Methods, A systematic review identified case reports of any serious events associated with PEG or NaP. Reports to the Food and Drug Administration (FDA) were also examined. Results, Fifty-eight publications of significant events in 109 patients using NaP and 22 patients using PEG were identified. As the total number of prescriptions issued is unknown, rates for the two agents cannot be directly compared. Most commonly reported were electrolyte disturbances, renal failure and colonic ulceration for NaP and Mallory,Weiss tear, electrolyte disturbances and allergic reactions for PEG between January 2006 and December 2007; there were 171 cases of renal failure reported to the FDA following use of NaP and 10 following PEG. Conclusions, Adverse events following bowel preparation are uncommon, but potentially serious. Given that many of these patients are healthy individuals undergoing screening, the benefit/risk ratio must be carefully considered when deciding which preparation to prescribe in individual patients. [source] Use of parenteral iron products and serious anaphylactic-type reactions,,§AMERICAN JOURNAL OF HEMATOLOGY, Issue 9 2010Diane K. Wysowski Controversy exists about the safety of the parenteral iron dextran products, Dexferrum and INFeD, which have been associated with rare, serious anaphylactic-type reactions. In the United States, their product labels carry boxed warnings of this adverse event; some have called for the withdrawal from marketing of the higher molecular weight Dexferrum. Between 2002 and 2007, sales of Dexferrum, INFeD, and iron gluconate Ferrlecit declined 32.5%, 21%, and 4.8%, respectively, while sales of iron sucrose Venofer increased 160%. Voluntary reports submitted to the Food and Drug Administration show anaphylactic reactions and symptoms for the four parenteral iron products. Because of underreporting, possible differential reporting, absence of iron dextran brand names, and incomplete use (denominator) data, incidence rates and relative risk estimates cannot be calculated. U.S. death certificate data show that for most years from 1979 through 2006, no more than 3 deaths per year were coded to "adverse events in therapeutic use of iron preparations;" brand names were not consistently recorded. Emergency department data show small numbers of visits for treatment of allergic reactions with intravenous iron preparations. The data presented herein show that allergic reactions are possible with all four parenteral iron products, and it is difficult to determine which product has the largest risk based on sales data, voluntarily submitted adverse event reports, death certificates, ED visits, and observational studies performed to date. To help differentiate risk among the parenteral iron products, the brand name of the product always should be provided on medical records, death certificates, and adverse drug reaction reports. Am. J. Hematol., 2010. Published 2010 Wiley-Liss, Inc. [source] Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical OverstressPACING AND CLINICAL ELECTROPHYSIOLOGY, Issue 7 2001ROBERT G. HAUSER Hauser, R., et al.: Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress. Because it is a lifesaving device, the unexpected failure of an ICD can be catastrophic. We report ICD electronic circuit failure due to electrical overstress damage (EOS) to the high voltage hybrid circuit and other electronic components in a series of ICD pulse generator models. Data were obtained from the Multicenter Registry of Pacemaker and ICD Pacemaker and Lead Failures, and from the manufacturers' adverse event reports, that were in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. Of 16 nonbattery Guidant/CPI ICD pulse generator failures reported to the registry, 6 (38%) have been confirmed by the manufacturer to be EOS related, and Guidant/CPI has reported 273 such failures to the FDA as of 12/29/00. The signs of failure included loss of telemetry and inability to deliver therapy, and some patients have experienced serious adverse events. Hybrid circuit damage may have occurred during capacitor charging or reform, and the majority appears to have happened during normal ICD function. While the incidence of this problem is unknown, a management strategy should be adopted that includes routine follow-up every 3 months and device evaluation after a shock or exposure to external defibrillation or electrosurgical devices. This study suggests that additional data are needed to determine the incidence of this problem, and that our present methods for monitoring the performance of ICDs following market release are inadequate. [source] Guidelines for submitting adverse event reports for publication,,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 5 2007FISPE (Chair), William N. Kelly Pharm D Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events. Copyright © 2007 Kelly et al. Reproduced with permission by John Wiley & Sons, Ltd. [source] What remains of that day: The survival of children's autobiographical memories across timeAPPLIED COGNITIVE PSYCHOLOGY, Issue 4 2010Gwynn Morris In this study we investigated the contributions of the content and the coherence of initial event reports to the survival of autobiographical memories during part of the lifespan eventually obscured by childhood amnesia. Over 100 children reported personal experiences when they were 4, 6 or 8 years old, enabling a determination of age-related differences in two aspects of narrative coherence: Theme and chronology. Content was assessed separately through the presentation of directed memory probes. After a 1-year delay, younger children more frequently failed to report target experiences. Multilevel modelling indicated that the survivability of a memory was predicted over and above the child's age by high thematic coherence of the initial memory narrative, but not by the memory content. It is possible that memories described in a highly thematically coherent narrative are indicative of well-integrated event memories, and thus likely to be cued more often, resulting in their long-term survival. Copyright © 2009 John Wiley & Sons, Ltd. [source] Do early interviews affect children's long-term event recall?APPLIED COGNITIVE PSYCHOLOGY, Issue 7 2004Margaret-Ellen Pipe The present study examined the effects of the timing of an initial interview on children's recall of an event over delays of 1 and 2 years. Fifty-five children who had originally participated in a novel event when they were between 5- and 6-years old and had been interviewed about it following either short (1 week or less) or long (1 or 6 month) delays were re-interviewed 1 and 2 years after the original experience. An additional 20 children not interviewed prior to the 1-year interview were included as a no-prior-interview control group. Long delays to the initial interview led to better open-ended recall at the 1-year delay than short delays to initial interview or no prior interview. However, initial interviews that followed short delays had a greater impact on children's responses to specific questions. The results suggest that prior interview history is an important consideration when examining the effects of long delays on children's event reports, and that the effects of the timing of an initial interview depend on the nature of the information recalled. Copyright © 2004 John Wiley & Sons, Ltd. [source] How quickly do children forget events?APPLIED COGNITIVE PSYCHOLOGY, Issue 7 2002A systematic study of children's event reports as a function of delay Sixty-six children aged between 5 and 7 years participated in the event, ,Visiting the Pirate', and were interviewed about it at one of five delays, namely, no delay (immediate interview), or at a 1-week, 1-day, 1-month or 6-month delay. For open-ended recall, a significant decrease in the amount of information reported was detected only at the 6-month delay, although forgetting functions indicated forgetting was most rapid at the shorter delays. Accuracy of open-ended recall was maintained over all delays. In contrast, in response to specific, leading and misleading questions, accuracy had decreased significantly by the 6-month delay. The theoretical and practical implications of these findings regarding the effects of delays on children's event reports are discussed. Copyright © 2002 John Wiley & Sons, Ltd. [source] Emergency Medical Services Provider Perceptions of the Nature of Adverse Events and Near-misses in Out-of-hospital Care: An Ethnographic ViewACADEMIC EMERGENCY MEDICINE, Issue 7 2008EMT-P, Rollin J. Fairbanks MD Abstract Objectives:, The objectives were to examine the perceptions of emergency medical services (EMS) providers regarding near-misses and adverse events in out-of-hospital care. Methods:, This study uses qualitative methods (focus groups, interviews, event reporting) to examine the perceptions of EMS providers regarding near-misses and adverse events in out-of-hospital care. Results were reviewed by five researchers; analytic domains were assigned and emerging themes were identified. Descriptive statistics were calculated. Results:, Fifteen in-depth interviews (73% advanced life support [ALS], 40% volunteer, and 87% male) resulted in 50 event descriptions. Eleven additional event reports were obtained from the anonymous reporting system. Of the 61 total events, 27 (44%) were near-misses and 34 (56%) were adverse events. Fourteen (23%) involved a child (<19 years). Types of error included 33 clinical judgment (54%), 13 skill performance (21%), 9 medication event (15%), 3 destination choice (5%), and 3 others (5%). For the 21 cases where the provider discussed the event, 10 (48%) were reported to a physician, and 9 (43%) to a supervisor; 4 (19%) were not reported, and none were reported to the patient. Focus groups supported interview and event report data. Emerging themes included a focus on the errors of others and a "blame-and-shame" culture. Conclusions:, Adverse events and near-misses were common among the EMS providers who participated in this study, but the culture discourages sharing of this information. Participants attributed many events to systems issues and to inadequacies of other provider groups. Further study is necessary to investigate whether these hypothesis-generating themes are generalizable to the EMS community as a whole. [source] | ||||||||||