Sentences with phrase «of adverse events associated»

Each year FDA receives a small number of reports of adverse events associated with pet treats.

Not exact matches

Examples of these risks, uncertainties and other factors include, but are not limited to the impact of: adverse general economic and related factors, such as fluctuating or increasing levels of unemployment, underemployment and the volatility of fuel prices, declines in the securities and real estate markets, and perceptions of these conditions that decrease the level of disposable income of consumers or consumer confidence; adverse events impacting the security of travel, such as terrorist acts, armed conflict and threats thereof, acts of piracy, and other international events; the risks and increased costs associated with operating internationally; our expansion into and investments in new markets; breaches in data security or other disturbances to our information technology and other networks; the spread of epidemics and viral outbreaks; adverse incidents involving cruise ships; changes in fuel prices and / or other cruise operating costs; any impairment of our tradenames or goodwill; our hedging strategies; our inability to obtain adequate insurance coverage; our substantial indebtedness, including the ability to raise additional capital to fund our operations, and to generate the necessary amount of cash to service our existing debt; restrictions in the agreements governing our indebtedness that limit our flexibility in operating our business; the significant portion of our assets pledged as collateral under our existing debt agreements and the ability of our creditors to accelerate the repayment of our indebtedness; volatility and disruptions in the global credit and financial markets, which may adversely affect our ability to borrow and could increase our counterparty credit risks, including those under our credit facilities, derivatives, contingent obligations, insurance contracts and new ship progress payment guarantees; fluctuations in foreign currency exchange rates; overcapacity in key markets or globally; our inability to recruit or retain qualified personnel or the loss of key personnel; future changes relating to how external distribution channels sell and market our cruises; our reliance on third parties to provide hotel management services to certain ships and certain other services; delays in our shipbuilding program and ship repairs, maintenance and refurbishments; future increases in the price of, or major changes or reduction in, commercial airline services; seasonal variations in passenger fare rates and occupancy levels at different times of the year; our ability to keep pace with developments in technology; amendments to our collective bargaining agreements for crew members and other employee relation issues; the continued availability of attractive port destinations; pending or threatened litigation, investigations and enforcement actions; changes involving the tax and environmental regulatory regimes in which we operate; and other factors set forth under «Risk Factors» in our most recently filed Annual Report on Form 10 - K and subsequent filings by the Company with the Securities and Exchange Commission.

Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners.

Medscape: The report points out that the age of the infant is an important factor in deciding how to treat a mother, because most adverse events associated with drug exposure through breast milk occur in infants younger than 2 months.

This is a pressing clinical challenge, as these patients are at greater risk for liver - related adverse events,» said Rebecca G. Wells, MD, associate editor of Cellular and Molecular Gastroenterology and Hepatology.

«But colon resection doesn't come for free — it's a major abdominal operation associated with the risk of serious adverse events.»

The results of this study highlight the importance of the guidelines to avoid adverse events associated with benzodiazepine and related drug use.

«As two organizations committed to the health and safety of workers, it makes sense for us to address the potential consequences of workforce marijuana use on employers, ranging from the risk and associated cost of adverse events to the possible loss of productivity,» said AAOHN President Jeannie Tomlinson.

«Inadequate postoperative pain relief is associated with the development of a variety of adverse events, including cardiac and pulmonary complications, chronic postsurgical pain, decreased patient satisfaction, and increased morbidity and mortality.»

A two - drug antihypertensive treatment that included a beta - blocker was associated with increased risk for major adverse cardiovascular events (MACEs) and death in a study of Danish patients who underwent noncardiac surgery, according to an article published online by JAMA Internal Medicine.

«There was no analysis of all critical parameters and critical processing steps to try to determine differences in the 2010 lots associated with Adverse Event reports compared to lots from previous seasons» the letter states.

Writing in the journal Neurobiology of Aging, a research team, led by senior author William S. Kremen, PhD, professor of psychiatry and co-director of the Center for Behavior Genetics of Aging at UC San Diego School of Medicine, found that major adverse events in life, such as divorce, separation, miscarriage or death of a family member or friend, can measurably accelerate aging in the brains of older men, even when controlling for such factors as cardiovascular risk, alcohol consumption, ethnicity and socioeconomic status, which are all associated with aging risk.

For example, providers may face increased liability for vaccine - related injury in patients whose genotype is associated with greater risk of adverse events following vaccination.

In the context of prevention, genomic discoveries could also be used to minimize vaccine - associated adverse events, and augment immune responses in individuals who would otherwise have low or no response to vaccination [7].

«This analysis of a large population of patients across a broad scope of tumor types suggests that avelumab was associated with an incidence of immune - related adverse events that is consistent with that of other immune checkpoint inhibitors.»

There is evidence that rTMS is safe and not associated with any adverse events, but given the variability in technique and outcome reporting that prevented meta - analysis, the evidence for efficacy of rTMS for seizure reduction is still lacking despite reasonable evidence that it is effective at reducing epileptiform discharges.

A zero CAC score is typically associated with very low risk of heart attack or other adverse cardiac event within 10 years (22).

RECENT STUDY ON ADVERSE EFFECTS OF LOW SODIUM INTAKE About the same time that U.S. health officials announced their new initiative to reduce salt intake, The Lancet published a large population - based study which showed persuasively that the risk of mortality and serious cardiovascular events increases significantly when salt intake drops below 3000 mg per day (two - thirds teaspoon) in an adult of average weight.3 The study also found that sodium intake in excess of seven grams per day (over three teaspoons salt) was associated with an increased risk in those with hypertension, but not in those without hypertensioOF LOW SODIUM INTAKE About the same time that U.S. health officials announced their new initiative to reduce salt intake, The Lancet published a large population - based study which showed persuasively that the risk of mortality and serious cardiovascular events increases significantly when salt intake drops below 3000 mg per day (two - thirds teaspoon) in an adult of average weight.3 The study also found that sodium intake in excess of seven grams per day (over three teaspoons salt) was associated with an increased risk in those with hypertension, but not in those without hypertensioof mortality and serious cardiovascular events increases significantly when salt intake drops below 3000 mg per day (two - thirds teaspoon) in an adult of average weight.3 The study also found that sodium intake in excess of seven grams per day (over three teaspoons salt) was associated with an increased risk in those with hypertension, but not in those without hypertensioof average weight.3 The study also found that sodium intake in excess of seven grams per day (over three teaspoons salt) was associated with an increased risk in those with hypertension, but not in those without hypertensioof seven grams per day (over three teaspoons salt) was associated with an increased risk in those with hypertension, but not in those without hypertension.

Increased TMAO levels are associated with an increased risk of incident major adverse cardiovascular events.

History of safe traditional use No case reports of significant adverse events with high probability of causality No significant adverse events in clinical trials No identified concerns for use during pregnancy or lactation No innately toxic constituents Toxicity associated with excessive use is not a basis for exclusion from this class Minor or self - limiting side effects are not bases for exclusion from this class»

Such statements reflect the current views of Barnes & Noble with respect to future events, the outcome of which is subject to certain risks, including, among others, the general economic environment and consumer spending patterns, decreased consumer demand for Barnes & Noble's products, low growth or declining sales and net income due to various factors, possible disruptions in Barnes & Noble's computer systems, telephone systems or supply chain, possible risks associated with data privacy, information security and intellectual property, possible work stoppages or increases in labor costs, possible increases in shipping rates or interruptions in shipping service, effects of competition, possible risks that inventory in channels of distribution may be larger than able to be sold, possible risks associated with changes in the strategic direction of the device business, including possible reduction in sales of content, accessories and other merchandise and other adverse financial impacts, possible risk that component parts will be rendered obsolete or otherwise not be able to be effectively utilized in devices to be sold, possible risk that financial and operational forecasts and projections are not achieved, possible risk that returns from consumers or channels of distribution may be greater than estimated, the risk that digital sales growth is less than expectations and the risk that it does not exceed the rate of investment spend, higher - than - anticipated store closing or relocation costs, higher interest rates, the performance of Barnes & Noble's online, digital and other initiatives, the success of Barnes & Noble's strategic investments, unanticipated increases in merchandise, component or occupancy costs, unanticipated adverse litigation results or effects, product and component shortages, the potential adverse impact on the Company's businesses resulting from the Company's prior reviews of strategic alternatives and the potential separation of the Company's businesses, the risk that the transactions with Microsoft and Pearson do not achieve the expected benefits for the parties or impose costs on the Company in excess of what the Company anticipates, including the risk that NOOK Media's applications are not commercially successful or that the expected distribution of those applications is not achieved, risks associated with the international expansion contemplated by the relationship with Microsoft, including that it is not successful or is delayed, the risk that NOOK Media is not able to perform its obligations under the Microsoft and Pearson commercial agreements and the consequences thereof, risks associated with the restatement contained in, the delayed filing of, and the material weakness in internal controls described in Barnes & Noble's Annual Report on Form 10 - K for the fiscal year ended April 27, 2013, risks associated with the SEC investigation disclosed in the quarterly report on Form 10 - Q for the fiscal quarter ended October 26, 2013, risks associated with the ongoing efforts to rationalize the NOOK business and the expected costs and benefits of such efforts and associated risks and other factors which may be outside of Barnes & Noble's control, including those factors discussed in detail in Item 1A, «Risk Factors,» in Barnes & Noble's Annual Report on Form 10 - K for the fiscal year ended April 27, 2013, and in Barnes & Noble's other filings made hereafter from time to time with the SEC.

Such statements reflect the current views of Barnes & Noble with respect to future events, the outcome of which is subject to certain risks, including, among others, the effect of the proposed separation of NOOK Media, the general economic environment and consumer spending patterns, decreased consumer demand for Barnes & Noble's products, low growth or declining sales and net income due to various factors, possible disruptions in Barnes & Noble's computer systems, telephone systems or supply chain, possible risks associated with data privacy, information security and intellectual property, possible work stoppages or increases in labor costs, possible increases in shipping rates or interruptions in shipping service, effects of competition, possible risks that inventory in channels of distribution may be larger than able to be sold, possible risks associated with changes in the strategic direction of the device business, including possible reduction in sales of content, accessories and other merchandise and other adverse financial impacts, possible risk that component parts will be rendered obsolete or otherwise not be able to be effectively utilized in devices to be sold, possible risk that financial and operational forecasts and projections are not achieved, possible risk that returns from consumers or channels of distribution may be greater than estimated, the risk that digital sales growth is less than expectations and the risk that it does not exceed the rate of investment spend, higher - than - anticipated store closing or relocation costs, higher interest rates, the performance of Barnes & Noble's online, digital and other initiatives, the success of Barnes & Noble's strategic investments, unanticipated increases in merchandise, component or occupancy costs, unanticipated adverse litigation results or effects, product and component shortages, risks associated with the commercial agreement with Samsung, the potential adverse impact on the Company's businesses resulting from the Company's prior reviews of strategic alternatives and the potential separation of the Company's businesses (including with respect to the timing of the completion thereof), the risk that the transactions with Pearson and Samsung do not achieve the expected benefits for the parties or impose costs on the Company in excess of what the Company anticipates, including the risk that NOOK Media's applications are not commercially successful or that the expected distribution of those applications is not achieved, risks associated with the international expansion previously undertaken, including any risks associated with a reduction of international operations following termination of the Microsoft commercial agreement, the risk that NOOK Media is not able to perform its obligations under the Pearson and Samsung commercial agreements and the consequences thereof, the risks associated with the termination of Microsoft commercial agreement, including potential customer losses, risks associated with the restatement contained in, the delayed filing of, and the material weakness in internal controls described in Barnes & Noble's Annual Report on Form 10 - K for the fiscal year ended April 27, 2013, risks associated with the SEC investigation disclosed in the quarterly report on Form 10 - Q for the fiscal quarter ended October 26, 2013, risks associated with the ongoing efforts to rationalize the NOOK business and the expected costs and benefits of such efforts and associated risks and other factors which may be outside of Barnes & Noble's control, including those factors discussed in detail in Item 1A, «Risk Factors,» in Barnes & Noble's Annual Report on Form 10 - K for the fiscal year ended May 3, 2014, and in Barnes & Noble's other filings made hereafter from time to time with the SEC.

Such statements reflect the current views of Barnes & Noble with respect to future events, the outcome of which is subject to certain risks, including, among others, the general economic environment and consumer spending patterns, decreased consumer demand for Barnes & Noble's products, low growth or declining sales and net income due to various factors, including store closings, higher - than - anticipated or increasing costs, including with respect to store closings, relocation, occupancy (including in connection with lease renewals) and labor costs, the effects of competition, the risk of insufficient access to financing to implement future business initiatives, risks associated with data privacy and information security, risks associated with Barnes & Noble's supply chain, including possible delays and disruptions and increases in shipping rates, various risks associated with the digital business, including the possible loss of customers, declines in digital content sales, risks and costs associated with ongoing efforts to rationalize the digital business and the digital business not being able to perform its obligations under the Samsung commercial agreement and the consequences thereof, the risk that financial and operational forecasts and projections are not achieved, the performance of Barnes & Noble's initiatives including but not limited to its new store concept and e-commerce initiatives, unanticipated adverse litigation results or effects, potential infringement of Barnes & Noble's intellectual property by third parties or by Barnes & Noble of the intellectual property of third parties, and other factors, including those factors discussed in detail in Item 1A, «Risk Factors,» in Barnes & Noble's Annual Report on Form 10 - K for the fiscal year ended April 30, 2016, and in Barnes & Noble's other filings made hereafter from time to time with the SEC.

Please inform us of any vaccine - associated adverse event and follow - ups that may have occurred.

Adverse drug events are undesired side effects associated with a drug or a lack of effect (the drug doesn't do what it's supposed to do).

The Vaccination Guidelines Group also acknowledges that «there is gross under - reporting of vaccine - associated adverse events which impedes knowledge of the ongoing safety of these products» Day MJ, Horzinek MC and Schultz RD. Journal of Small Animal Practice.

In 2007, World Small Animal Veterinary Association Vaccine Guidelines reports said that there is «gross under - reporting of vaccine - associated adverse events which impedes knowledge of the ongoing safety of these products».

No wonder the dog and cat vaccination guidelines of the World Small Animal Veterinary Association note that «there is gross under - reporting of vaccine - associated adverse events which impedes knowledge of the ongoing safety of these products».

The 2007 World Small Animal Veterinary Association (WSAVA) Vaccine Guidelines reports (regarding all vaccines) there is: «gross under - reporting of vaccine - associated adverse events which impedes knowledge of the ongoing safety of these products.»

Likewise, we may refuse to provide financial support in the event of an adverse experience, lack of efficacy or quality defect associated with such products.

Manufacturers of spot - on flea - and - tick products have six months to make labeling changes, according to a new directive from the Environmental Protection Agency, to address increasing adverse events associated with the misapplication of these products by pet owners.

Professor Schultz is an author of the companion animal vaccination guidelines, which acknowledge that «there is gross under - reporting of vaccine - associated adverse events, because of the passive nature of reporting schemes, which impedes knowledge of the ongoing safety of these products».

Multiple recent adverse life events including relationship strain, especially for younger men was associated with higher risk of alcohol misuse.

This is a review of the literature that examines the exposure to violence as a psychosocial stressor that is independently associated with asthma morbidity even after adjustment for income, housing, and other adverse life events.

Afifi, T.O., Enns, M.W., Cox, B.J., Asmundson, G.J.G., Stein, M.B. and Sareen, J. (2008) Population attributable fractions of psychiatric disorders and suicidal ideation and attempts associated with adverse childhood events in the general population.

The analysis revealed that factors associated with a poor father - child relationship measured at age 10 (i.e. «current» factors) include: a male child; unmarried parents; low family socio - economic status; recent adverse family events; and the presence of a father figure rather than the biological father.

Several early family characteristics (whether one or both parents from a minority ethnic group, both parents» ages when their child was born, the number of children in the family, adverse family events such as illnesses and deaths) are not associated with later father - child relationships.

Male child gender, lower family socio - economic status, unmarried parents, recent experience of adverse family events and living with a non-biological father figure are all current risk factors independently associated with poor father - child relationships

Examples of risk factors that have been found to be associated with depression included partner conflict, single - parenthood, low education and stressful life events [44, 45, 46], which have all, in turn, been related to greater risk of adverse outcomes in children [47, 48, 49].

A growing body of evidence suggests that stressors associated with war - related events may predispose youth to adverse outcomes.10 - 17 This stream of research is consistent with family systems theory, which suggests that the experiences of a military - connected parent will affect the functioning of youth in that family system.18 Although some studies have considered the impact of military life during wartime, 12,17,19 to our knowledge, most researchers have examined negative outcomes associated specifically with deployments.1, 7,20 These studies have examined the psychosocial functioning of children during the deployment of a parent4, 14 or following 1 or multiple deployments.11, 13,21 Although many military - connected youth fare relatively well despite stressors, these studies concluded that a sizeable proportion appears to struggle with experiences of deployment and other war - related stressors.

After LASSO selection, the model showed a total explained deviance of 55.2 % (see Table 3) and showed that parental ADHD (27.2 %), higher levels of adverse life events (6.0 %), and maternal smoking during pregnancy (1.3 %) were associated with a heightened risk for ADHD - only compared with controls.

Different kinds of SoM reflecting insecure attachment differentiated the clinical groups studied, with OCD predominantly showing dismissing traits and depression attachment SoM commonly associated with severe adverse events.