Sentences with phrase «adverse event data»

Not exact matches

The Finnish drug maker on Sunday presented results from phase I trial of a prostate cancer treatment, saying according the data it «has been well tolerated, with no significant treatment - related adverse events.»

The company reported that one patient saw a serious adverse event after the data collection cut - off.

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.

Where data were given for just one baby of the multiples, we need to know if it was decided beforehand which baby would contribute data (e.g. the first born), or if any adverse event was reported for whichever baby it happened to.

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).»

«Some may question the reliability of these data because the adverse events were determined and classified by investigators from the pharmaceutical company,» Emanuel said.

In certain patient groups or aspects of side effects (serious adverse events and treatment discontinuation), however, the data were robust and therefore conclusions could be drawn.

Data were available for the following outcomes: overall survival, time to first skeletal - related complication, adverse events and health - related quality of life.

This data was then compared with patients» outcomes, including heart attack or the occurrence of major adverse cardiac events within 30 days.

The lack of data on the characteristics of the users of medical marijuana, their medical conditions, and use patterns, as well as adverse events they may suffer by using different variations of the drug is an important knowledge gap.

Regarding the robustness of the data, however, there were exceptions in certain patient groups or aspects of side effects (serious adverse events and treatment discontinuation).

After adjusting the data for age, sex, race, education, smoking, alcohol use, blood pressure, diabetes, high blood pressure medication, cholesterol levels, statin use and body mass index, the researchers found that those people who met both the recommended activity levels and had vitamin D levels above 20 nanograms per milliliter experienced about a 23 percent less chance of having an adverse cardiovascular event than those people with poor physical activity who were deficient for vitamin D. On the other hand, people who had adequate exercise but were vitamin D deficient didn't have a reduced risk of an adverse event.

Putting the data into the CTD framework helps investigators develop and test hypotheses about how drugs might cause adverse events.

Limitations of the study include that causality of adverse events can not be determined from the data, health outcomes are self - reported and reports from consumers vs. health care professionals can not be distinguished.

«The more data a state has regarding the circumstances of an adverse event, the harder it is for a provider to be untruthful,» the researchers argue in their paper.

If, say, an unexpected adverse event pops up in a human trial, the informaticians can then sift animal, lab, and human data to investigate the possibility that certain gene variants or other factors predispose patients to the adverse event.

As part of the approval, the manufacturer must conduct a five year post approval study that will follow at least 100 patients and collect additional safety and effectiveness data including weight loss, adverse events, surgical revisions and explants and changes in obesity - related conditions.

«Our data show that daily cannabis users had no greater risk than non-users (control group) to experience serious adverse events,» Dr. Ware who is also a researcher from the Brain Repair and Integrative Neuroscience Program at the RI - MUHC.

The study analyzed data on 474,662 women who received anesthesia during labor, although adverse events (whether or not they occurred) were tracked in only a portion of patients.

Data on anesthesia adverse events collected through the Anesthesia Quality Institute's (AQI) National Anesthesia Clinical Outcomes Registry (NACOR) are being presented at the ANESTHESIOLOGY ™ 2014 annual meeting.

Combining information from multiple U.S. data sources, researchers found that mothers with preeclampsia and their infants were at a significantly increased risk for adverse health events compared to mothers without preeclampsia (increased 4.6 % to 10.1 % in mothers and 7.8 % to 15.4 % in infants within 12 months of childbirth).

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.

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.

the disclosure of certain enumerated events affecting a municipal security; these events include the following, if material: (1) principal and interest payment delinquencies; (2) non-payment related defaults; (3) unscheduled draws on debt service reserves; (4) unscheduled draws on credit enhancements; (5) substitution of credit or liquidity providers; (6) adverse tax events affecting the tax - exempt status of the security; (7) modifications to rights of securities holders; (8) bond calls; (9) defeasances; (10) release, substitution, or sale of property securing repayment; (11) rating changes; (12) failure to provide annual financial information as required; the MSRB, Electronic Municipal Market Access (a.k.a. EMMA) provides free access to municipal disclosures, market data and education

Clinical research data and analysis of adverse events to date do not demonstrate a causal relationship between BRAVECTO ® and liver or kidney issues or cancer.

It is a personal mission of mine, to collect data about adverse events with essential oils and animals, and I must say it is nearly impossible to find out brands, lot numbers, obtain samples, names of those involved, and veterinary records connected with any of the past «toxicity» reports.

A paper reporting a «rigorous double blind» study — the VIGOR trial — was submitted to NEJM in 1998, got through peer review at one of the most up - tight journals in the world of medicine, and — by way of cherry - picking the data submitted (selecting out some study subjects whose adverse events histories which, if considered, would've significantly affected the safety profile for rofecoxib and revealed something that Merck really didn't want us prescribers to learn about their «blockbuster» product — was published to be touted by Merck's marketing weevils as solid proofs of Vioxx's tolerability, efficacy, and safety.

The firm undertook an analysis of data in the FDA's Adverse Event Reporting System related to the stomach disorder drug,...

The firm undertook an analysis of data in the FDA's Adverse Event Reporting System related to the stomach disorder drug, and «identified at least 106 cases of tardive dyskinesia or other movement disorders reported among users of Reglan or its generic version, metoclopramide.»

• I was trained on performance of Pre-Clinical Study, Patient Registration and Inform Consent, SAE and Safety Data Reconciliation and reporting of Adverse Events in compliance with IRB stipulations.

Medical Data Coordinator 5/2000 — 11/2003 Coded adverse events, medical histories, medications, medication indications and other project - related coding to facilitate summarization, analysis, and reporting of dData Coordinator 5/2000 — 11/2003 Coded adverse events, medical histories, medications, medication indications and other project - related coding to facilitate summarization, analysis, and reporting of datadata.

Data processing including updating, cleaning, quality checks on the database, and Serious Adverse Event reconciliation to highlight discrepancies.

Checked, edited, reviewed and clarified adverse events, concomitant medications and other data as needed on projects.

Review and process ICSRs of adverse events obtained from various sources including spontaneous, clinical trials accurately to determine regulatory reporting requirements and ensure quality data

Oversaw all activities that ensured the completeness and validity of the clinical trial database, including authoring the data validation and query management process, adverse event and medication coding, and SAE reconciliation.

Core Competencies CDMS • Adverse Events • Single and Double Data Entry • Data Coding • Clinical Study Reports MedDRA / WHOART Dictionaries • Medidata RAVE Data Capture • eCTD • Data Validation

Trained on performance of Pre-Clinical Study, Patient Registration and Inform Consent, SAE and Safety Data Reconciliation and reporting of Adverse Events in compliance with IRB stipulations.

Expertise in BA / BE studies, managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.

Dr Taylor has been working on a Lowitja Institute project to measure the incidence of adverse events in hospitals experienced by Aboriginal and Torres Strait Islander peoples using data from the Australian Institute of Health and Welfare.

The studies did not present data on adverse events, and results for withdrawals were generally inconclusive.

For other risk factors, there were some missing data (20.7 % deviant peers, 6.1 % parental warmth, 4.1 % SES, 1.6 % adverse life events), which were mainly due to not assessed questionnaires, logistic problems or incompletely filled out questionnaire, and were randomly distributed over the groups.