Sentences with phrase «related adverse events reported»

Not exact matches

More details: Teva Pharmaceuticals has not received any reports of adverse events or complaints related to this recall.

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.

One related Grade 3 or greater adverse event of Grade 3 increased blood phosphorus was reported.

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.»

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

«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.

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

Two serious adverse events (pneumonia and fentanyl - related hypersensitivity) that were not considered drug related were reported.

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.

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.

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.

Although all patients had treatment - related serious adverse events, no grade 4 events or dose - limiting toxicities were reported (Tables 1 and 2).

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.»

Remember that adverse events are vastly under - reported and the incidence of vaccine related disease is much higher than you would think.

If you have product - related questions or wish to report an adverse event associated with a Zoetis product, including a human exposure, please contact our Veterinary Medical Information & Product Support Team at 1 -888-ZOETIS-1 or 1-888-963-8471

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.»

Cardiologists and Risk Managers will be reporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA's MedWatch Safety Information and Adverse Event Reportingreporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA's MedWatch Safety Information and Adverse Event ReportingReporting Program.

The majority of the adverse event reports were related to kidney problems, ranging from kidney stones to kidney failure.

Additionally, our lawyers understand the regulatory process and have supported clients with supplemental reporting following clinical trial claims, documentation for PMA and 510 (k) device litigation, and with regulatory filings involving inquiries relating to possible adverse events.

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 data.