Sentences with phrase «adverse events reported in»

There were no harms or adverse events reported in both phases.»

Serious adverse events reported in the clinical study included nausea, pain at the neuroregulator site, vomiting, as well as surgical complications.

Importantly, these benefits were achieved with just one - third the rate of serious adverse events reported in the standard chemotherapy group.

Not exact matches

The scope of the challenge can be sized up in the FDA's Adverse Events Reporting System.

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.

In a letter to Martek FDA said: «some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice and apnea in infants fed long - chain polyunsaturated fatty acids.&raquIn a letter to Martek FDA said: «some studies have reported adverse events and other morbidities including diarrhea, flatulence, jaundice and apnea in infants fed long - chain polyunsaturated fatty acids.&raquin infants fed long - chain polyunsaturated fatty acids.»

There were no significant differences in adverse events between groups, which were reported by 2 % of children taking the three types of honey compared to 1 % taking placebo.

Breastfeeding was more effective in reducing crying duration or pain scores during vaccination compared to: 25 % dextrose and topical anaesthetic cream (EMLA), vapocoolant, maternal cuddling, and massage.No included studies reported adverse events.

Also, there is no reporting of medical errors in the U.S., so we really don't have the data to draw conclusions, but the Institute of Medicine in 2000 reported that «at least 44,000 and perhaps as many as 98,000 Americans die in hospitals each year as a result of medical errors,» meaning that «deaths due to preventable adverse events in hospitalized patients exceed the deaths attributable to motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516).»

One important point for me is that there were no adverse events (scientific - speak for bad side effects) reported in either the 2010 study or the 2014 study.

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.

A total of 647 serious adverse events were reported, 402 (62 %) in the vaccine group and 245 (38 %) in the placebo group.

In fact, after follow - up (2.5 to 3.1 years), there were a total of 216 adverse events reported among study participants including 108 deaths, of which 27 were cardiovascular, plus 34 heart attacks, 30 strokes, 18 experienced unstable angina and hospitalized, and 79 needed revascularization procedures.

The therapy had a favorable safety profile with the most common adverse event reported as irritation at injection site, which was reported in the placebo group as well.

Patients with multiple health issues and who are at higher risk of adverse events are less likely to receive follow - up care from a physician after visiting an emergency department for chest pain, reports a study published in CMAJ (Canadian Medical Association Journal)

Professor Marco Metra, director of the Institute of Cardiology at the University and Civil Hospital of Brescia, Italy and co-principal investigator of RELAX - AHF, said: «We have reported that all of these adverse effects of a worsening heart failure event are related to increased overall mortality and that a worsening heart failure event itself is related to a two-fold increased risk of dying in 180 days.»

In 2009, however, varenicline received a black box warning by the FDA based on their adverse event reports of neuropsychiatric symptoms like depression and thoughts of suicide.

Over a 10 - year period, from 2006 to 2016, the FDA collected reports of «adverse events» in more than 370 children who had used Hyland's homeopathic teething tablets or gel, a similar product that is applied directly to a baby's gums.

In light of antipsychotic treatment - emergent cardiometabolic adverse events, several government reports called for efforts to improve pediatric psychotropic medication oversight in state Medicaid agencieIn light of antipsychotic treatment - emergent cardiometabolic adverse events, several government reports called for efforts to improve pediatric psychotropic medication oversight in state Medicaid agenciein state Medicaid agencies.

Serious adverse events were reported in 9 % of patients and treatment discontinuation related to adverse events in 3.1 %.

A new research letter published by JAMA Internal Medicine examines adverse events for cosmetics and personal care products in the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CFSAN), a repository made publically available iadverse events for cosmetics and personal care products in the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CFSAN), a repository made publically available iAdverse Event Reporting System (CFSAN), a repository made publically available in 2016.

«It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product,» the spokeswoman, Lyndsay Meyer, said in a statement.

In the seven years since then, there has been a steady stream of reports of adverse events tied to Hyland's homeopathic teething products.

«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.

Sixty - nine percent of patients experienced simeprevir - related adverse events while 86 percent in the telaprevir group reported telaprevir - related adverse events.

Dr. Chen went on to point out that, though 56 of the patients treated in the study experienced mild peripheral neuropathy (an adverse event characterized by tingling in the extremities, commonly reported among those treated with BV), 88 percent reported that symptoms abated over time.

There were no deaths or hospitalizations reported in any included studies of the drugs, but commonly reported adverse events included dizziness, fatigue, confusion, and visual disturbances.

The NIH registry proved far more complete, especially for reporting adverse events — signs that a therapy might be going badly wrong.Piller has noted earlier in the story how some institutions point to published scientific papers as a place they have reported findings.

Pramod Srivastava, Giorgio Parmiani, and colleagues report that immunization with autologous tumor - derived gp96 - peptide complexes elicits tumor regression in stage IV melanoma patients, without any immunization - related adverse events.

No adverse events or complications was reported in 4 - month outcome.

Fewer patients in the combination group reported grade 3/4 adverse events than in either of the other groups, at 58 % compared with 66 % in the encorafenib group and 63 % of the vemurafenib patients.

Grade 3 local adverse events consisted mainly of injection site swelling (Figure 2), which was reported in all study groups, but had a higher frequency in the 50 µg malaria vaccine group.

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.

The ocular adverse events most frequently reported in the therapy group were mainly related to the injection procedure, except for the occurrence of intraocular inflammation (accompanied by elevation of intraocular pressure in some patients) that is likely related to GS010, and which was responsive to conventional treatment and without sequelae.

to entities regulated by the Food and Drug Administration, if necessary, to report adverse events, product defects, or to participate in product recalls;

Stem Cell Reports promotes transparency in stem cell research and related fields of research through the publication of confirmatory findings, negative results, and adverse events.

A 2015 Cochrane review of current research on cryotherapy also came to a similar conclusion: «There is insufficient evidence to determine whether whole - body cryotherapy (WBC) reduces self - reported muscle soreness or improves subjective recovery after exercise compared with passive rest or no WBC... Further high - quality, well - reported research in this area is required and must provide detailed reporting of adverse events.»

In contrast, US drug manufacturers are required to make a full report on all adverse events to the FDA, and for an event that is regarded as both serious and unexpected, the report must be made «as soon as possible, but not later than 15 days after» it becomes known.

The researchers cautioned that the adverse events database from the FDA isn't the ideal solution for comparing adverse event rates in type 2 diabetes drugs, due to its known limitations, like reporting biases and incomplete data.

The FDA is collecting reports of adverse events that have occurred in people who took products marketed as «energy drinks» or «energy shots.»

However, manufacturers and distributors are now required to send reports of Adverse Event Reactions to the FDA, thanks to the Dietary Supplement and Nonprescription Drug Consumer Protection Act passed in the late 2016.

(5) Compare this to no reported adverse events from bio-identical hormones in 2008, according to an FDA press conference January 2008.

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»

In this study of both stevioside and rebaudioside A in Food and Chemical Toxicology in 2008... ``... No safety concerns were noted as determined by reporting of adverse events, laboratory assessments of safety or vital signs.&raquIn this study of both stevioside and rebaudioside A in Food and Chemical Toxicology in 2008... ``... No safety concerns were noted as determined by reporting of adverse events, laboratory assessments of safety or vital signs.&raquin Food and Chemical Toxicology in 2008... ``... No safety concerns were noted as determined by reporting of adverse events, laboratory assessments of safety or vital signs.&raquin 2008... ``... No safety concerns were noted as determined by reporting of adverse events, laboratory assessments of safety or vital signs.»

A course that fills an urgent need in the health care field because literally no Medical School teaches anything more than a lesson or two on this polarizing and diverse subject often leaving Licensed MD and NDs alike at a severe disadvantage when it comes to being able to interpret Vaccine Ingredients, How to Identify Vaccine Injuries, and How to Report Them as well per the Vaccine Adverse Events Reporting System established by the 1986 National Vaccine Law.

Over the period 2008 to 2011, the Government Accountability Office (GAO) of the United States received 6,307 reports of health problems (identified as adverse events) from use of dietary supplements containing a combination of ingredients in manufactured vitamins, minerals or other supplement products, [72] with 92 % of tested herbal supplements containing lead and 80 % containing other chemical contaminants.

There is evidence that vaccines may cause harm well beyond what would show up in an adverse events report — harm that may manifest over many years, rather than in the days and weeks immediately following vaccination.

The substantial reduction in risk of death, low adverse events reported and low costs related to this intervention suggest great potential for melatonin in treating cancer.»

Serious adverse events, such as hospitalization, procedure utilization, or death, were not reported in any of the evaluated studies with enough frequency to allow an assessment of whether the diet may have contributed to those events.

Reports to the FDA of serious adverse drug events, including deaths, have more than doubled in recent years.