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Incidence in Medical Technology

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

... estrogens. Across the SMART-1 trial, the incidence of treatment-emergent adverse events, breast ... The primary end point of the SMART-1 trial was incidence of endometrial hyperplasia at one year. Secondary ... 2. Bazedoxifene/Conjugated Estrogens (BZA/CE): incidence of Uterine Bleeding in Postmenopausal Women ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... statistically significant. Overall, the incidence of adverse events and serious adverse events was ... concern for advanced breast cancer patients, with incidence rates as high as 75 percent. When cancer spreads ... with certain types of advanced cancer, with incidence rates of nearly 100 percent in myeloma patients ...

5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH

... was associated with a significantly greater incidence of severe hypoglycemia than was insulin glargine ... was no observable trend for a difference in the incidence of serious adverse events including cancer, as ... was associated with a significantly greater incidence of severe hypoglycemia than was insulin glargine ...

Responses After Completion of Therapy Increase Pixantrone Complete Remission (CR)/Unconfirmed Complete Remission (CRu) Rate to 24% and Overall Response Rate (ORR) to 40% Compared to 7% and 14% for Comparator Agents in Phase III EXTEND Trial in 3rd Line Th

... versus 19.4% on the comparator arm. However, the incidence of grade 3, 4 febrile neutropenia was only 7.4% ... arm. Grade 3, 4 infections had a similar incidence in both study arms (18% vs. 13%). Although the ... (1.5% vs. 1.5%), there was a slightly higher incidence of serious cardiac disorders in patients treated ...

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

... of exposure, respectively. The unadjusted incidence of experiencing at least one CV event was 2.0 ... interval: 0.46-1.03). The Exposure Adjusted incidence Rate (expressed as per 1,000 patient years) was ... BYETTA provides sustained A1C control and low incidence of hypoglycemia when used with metformin or a ...

Pixantrone Produces High Rates of Complete and Partial Remissions Even Among Aggressive NHL Patients With Extensive Prior Doxorubicin Treatment or Prior Rituximab Treatment

... of over 550 mg/m2 are associated with a high incidence of CHF if the cumulative dose levels were solely ... that that while numerically higher, the overall incidence of cardiac events were lower than expected in ... versus 19.4% on the comparator arm. However, the incidence of grade 3, 4 febrile neutropenia was only 7.4% ...

IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant

... (oral valganciclovir) significantly reduced the incidence of CMV disease by 56% in high-risk kidney ... in 84% of patients and significantly reduced the incidence of CMV disease by 56%, compared to the current ... patients, there was a significantly higher incidence of tissue-invasive CMV disease in the ...

Living Donor Kidney Transplants Using Alemtuzumab Pre-Conditioning and Tacrolimus Monotherapy: Long-Term Safety and Efficacy

... and 57.6 (+/-24.6), respectively. The cumulative incidence of acute cellular rejection (ACR) at 1, 3, 6, 12, ... monotherapy. Among 60 recipients with ACR, the incidence of pre-weaning ACR was 8.5% and post-weaning ACR ... and 53.9 (+/-21.7), respectively. The cumulative incidence of ACR after 1, 3, 6, 12, 18, 24, 30, and 36 ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... in CAPACITY 1. While there was a slightly higher incidence of Grade 3 adverse events in the pirfenidone ... data from the CAPACITY studies pertaining to the incidence and cause of deaths, treatment discontinuations due to adverse events and laboratory tests. incidence and Cause of Deaths Analysis of ...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

... than placebo was edema. The placebo-subtracted incidence was 5.7 percent (5/20 mg), 6.2 percent (5/40 mg), ... mg), and 11.2 percent (10/40 mg). The edema incidence for placebo was 12.3 percent. Adverse ... at lower rates but at about the same or greater incidence as in patients receiving placebo included ...

RAPAFLO(TM) (silodosin) Provides Rapid and Sustained Benign Prostatic Hyperplasia (BPH) Symptom Relief in as Little as Three Days

... the targeted prostatic muscle tissue, with a low incidence of vasodilatory and orthostatic effects. ... (2.6% and 1.5%, respectively). In addition, the incidence of treatment-related dizziness was only slightly ... adverse event was dizziness. The incidence of treatment-related dizziness was low and only ...

Schering-Plough Highlights Hepatitis C Clinical Data Presentations at the European Association for the Study of the Liver (EASL) Annual Meeting

... report such cases by calling 1-800-593-2214. incidence of Adverse Events Most common adverse ... were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the ... as treatment continues. There was a 23-24% incidence overall for injection site reactions or ...

Phase 3 Trial of Nexavar in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint

... in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction ... Nexavar vs. 1.3% for placebo. In RCC patients, incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... were fatigue, anemia, nausea and headache. The incidence of skin adverse events (rash or pruritus) ... was shown in the HCV SPRINT-1 study to reduce the incidence of viral breakthrough regardless of treatment ... report such cases by calling 1-800-593-2214. incidence of Adverse Events Most common adverse ...

Newly Published Phase III Study Shows Arzoxifene Significantly Increased Bone Mineral Density

... the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with ... There were no significant differences in the incidence of endometrial hyperplasia or cancer between the ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

... report such cases by calling 1-800-593-2214. incidence of Adverse Events Most common adverse reactions ... were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the ... as treatment continues. There was a 23-24% incidence overall for injection site reactions or ...

Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C

... for baseline stratification factors). The incidence of serious and/or severe adverse events was 28.3% ... alfa-2a treatment group. The incidence of serious and/or severe pulmonary adverse events ... typically expected with interferon therapy. The incidence of discontinuations due to adverse events was ...

Compared to Standard Therapies, Pixantrone Decreases Time to Achieve Complete Remission by 47% in Relapsed Aggressive Non-Hodgkin's Lymphoma

... of treatment. Pixantrone recipients had a low incidence of severe neutropenia complicated by either fever ... Pixantrone patients also experienced a low incidence of hair loss, a very common side effect of other drugs in this class. Overall, the incidence of serious adverse events was similar between ...

ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients

... The primary efficacy endpoint was the incidence of CMV disease (either symptomatic CMV infection ... time to onset of CMV infection and disease; the incidence and time to onset of anti-CMV therapy; and ... CMV infection or disease; in addition to the incidence of adverse effects that limit the use of current ...

Mayo Clinic Study Finds Younger Men With Erectile Dysfunction at Double Risk of Heart Disease

... and older. Those initial data and the increasing incidence of erectile dysfunction over time were linked to ... dysfunction. Statistically, that's a cumulative incidence of 48.52 per 1,000 person years in those with ... In men in their 50s, 60s and 70s, the total incidence of new cases of heart disease also was higher in ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... interim analysis showed that Nplate reduced the incidence of clinically significant, treatment-related ... In controlled clinical studies, the incidence of thrombotic/thromboembolic complications was ... studies among patients with chronic ITP, the incidence of hematologic malignancy was low and similar ...

Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer

... of an antithrombotic medication can reduce the incidence of thromboembolic events in patients with cancer. ... experienced a major bleeding episode, and the incidence of minor bleeding in the treatment arm was ... this study confirms that nadroparin reduces the incidence of thromboembolic events in cancer patients ...

New Phase II Data Show Safety of Once-Daily Oral Factor Xa Inhibitor, DU-176b, Comparable to Warfarin in Patients With Non-Valvular Atrial Fibrillation

... as compared to warfarin. While the incidence of major and clinically relevant non-major ... 60 mg twice per day), compared with warfarin, the incidence reported in the once-daily DU-176b treatment ... The primary endpoints of the study were the incidence of bleeding events (major and clinically relevant ...

Studies Examine Quality of Care for Hospitalized Sickle Cell Disease Patients and Effective Methods for Detecting Risk of Stroke in Children With This Disorder

... the impact of the screening tool on the overall incidence of stroke in these patients had not been ... to classify based on available information). incidence rates for stroke were calculated and compared ... groups. The study found that the incidence of overt stroke in the pre-TCD group was ...

Bayer Announces Upcoming Presentations of Campath(R) and Leukine(R) Data at the 50th Annual Meeting of the American Society of Hematology

... the time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and ... doses greater than 90mg per week increase the incidence of pancytopenia. ... the time to neutrophil recovery and reduce the incidence of severe and life-threatening infections and ...

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

... such cases by calling 1-800-593-2214. incidence of Adverse Events There are no new ... PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, ... In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the ...

Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation

... 37 percent (p<0.001), dronedarone reduced the incidence of first non-AF related CV hospitalization (e.g. ... (p=0.016). Dronedarone did not increase the incidence of non-cardiovascular hospitalizations in comparison to the placebo arm. "The incidence of AF-related hospital admissions has ...

Boceprevir Phase II Study Showed High Rate of Sustained Response With 28- and 48-Week Regimens in Genotype 1 Treatment-Naive Hepatitis C Patients

... the addition of boceprevir appears to reduce the incidence of viral breakthrough regardless of treatment ... to report such cases by calling 1-800-593-2214. incidence of Adverse Events There are no new adverse ... PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, ...

Pivotal Data Showed SYMBICORT(R) Improved Lung Function in Adults with COPD

... its monocomponents and placebo.(2) The incidence of pneumonia-related adverse events were similar ... treatment arms compared to placebo.(2) -- The incidence of other potential lung infections (e.g., ... and placebo for up to 12 months.(4) The incidence of pneumonia-related adverse events were similar ...

New Data Show In Vitro Potency of Doripenem Against Resistant Bacteria

... meeting in Washington, D.C. In the study, the incidence and susceptibility of ... Additionally, the study examined the incidence of ESBLE and CIPRE in baseline Enterobacteriaceae ... The study results showed: -- Relative incidence of ESBLE was highest in Europe (8% of all ...

Derma Sciences' MEDIHONEY(TM) Proven to Speed Healing in Stalled Leg Ulcers

... that, "the [honey] group had shown a greater incidence of healing, more effective desloughing, and lower incidence of infection than the control group." CEO Ed ... an aging population, the rise in the global incidence of diabetes and chronic vascular disorders, and a ...

Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months

... low over six months of treatment. incidence of weight gain of 7 percent or more from baseline ... percent, all p less than or equal to .05). The incidence of all injection site reactions, including ... 2008 were also reviewed. As of 31 May 2008, the incidence of Olanzapine LAI Post-Injection Syndrome ...

Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis C Patients

... to report such cases by calling 1-800-593-2214. incidence of Adverse Events There are no new adverse ... PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, ... In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the ...

Independent Analyses of the SEAS, SHARP and IMPROVE-IT Studies of Ezetimibe

... risk (active vs placebo) suggested by the cancer incidence and mortality from all 3 trials together (or just ... appears to be a small increase in total cancer incidence in the group allocated ezetimibe + statin, but ... If there were a real adverse effect on cancer incidence or cancer mortality then previous experience with ...

Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss

... in both A1C and weight loss with a lower incidence of nausea than in previous exenatide studies. ... mm Hg for placebo (means +/- SEM). There was an incidence of reported nausea in both the 5 mcg and 10 ... 3 and 13 percent, respectively, which is a lower incidence than what was observed in previous studies, where ...

Kosan's Lead Hsp90 Inhibitor, Tanespimycin, Shows High Level of Activity in Trastuzumab Resistant/Refractory HER2-Positive Breast Cancer in a Phase 2 Trial

... 4 cycles), yielding an overall clinical benefit incidence of 63%. Common toxicities were mainly mild to ... rate of 22% and a clinical benefit incidence of 61%. -- For the Injectable Suspension ... rate of 33% and a clinical benefit incidence of 67%. -- Patients with an objective ...

Node-Negative Early Stage Breast Cancer Patients Benefit from Taxotere(R)-Based Chemotherapy

... the first cycle of TAC, in order to reduce the incidence and severity of hematological toxicities ... event (24.6%) reported with the TAC regimen. The incidence of febrile neutropenia decreased to 6.5% with the ... 25 years in western countries. In addition, the incidence is highest in western countries. This appears to ...

Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment

... to report such cases by calling 1-800-593-2214. incidence of Adverse Events There are no new adverse ... PEGINTRON as compared to INTRON A; however, the incidence of some (e.g., injection site reactions, fever, ... In the PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the ...

Nexavar Significantly Improves Overall Survival by 47 Percent in Asia-Pacific Liver Cancer Study

... region continues to grow because of a high incidence of chronic hepatitis B viral infections, which ... Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 ... in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction ...

Eribulin Mesylate Demonstrated Anti-Tumor Activity in Heavily Pretreated Patients with Advanced Breast Cancer

... Tolerability Profile, with Low incidence of Grade 3 and 4 Neuropathy WOODCLIFF LAKE, ... has a manageable tolerability profile, with a low incidence of Grade 3 (severe) and no Grade 4 (disabling or ... profile, particularly with regard to the low incidence of peripheral neuropathy," noted Vahdat. "None of ...
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(Date:4/16/2014)... ,, Sometimes known as Kennedy,s disease, spinal and bulbar muscular ... slowly progressive muscle weakness and atrophy. Researchers have long considered ... the cells in the spinal cord and brainstem that ... in the April 16, 2014 online issue of Neuron ...
(Date:4/16/2014)... thoughts and feelings are the result of neurons talking ... of the conversations might not be all that private. Brain ... even participating in, some of those discussions. But a new ... part of the time specifically, when the neurons get ...
(Date:4/16/2014)... Klaus Aktories and Dr. Panagiotis Papatheodorou from the Institute of ... Freiburg have discovered the receptor responsible for smuggling the toxin ... The TpeL toxin, which is formed by C. perfringens ... It is very similar to the toxins of many other ...
Breaking Biology News(10 mins):Mutant protein in muscle linked to neuromuscular disorder 2Eavesdropping on brain cell chatter 2Eavesdropping on brain cell chatter 3Gate for bacterial toxins found 2
(Date:4/16/2014)... marvel of the embryo. It begins as a glob of ... to become the cells of our lungs, muscles, nerves and ... in a feat of reverse tissue engineering, Stanford University researchers ... embryonic cells to proliferate and transform into all of the ...
(Date:4/16/2014)... Therapeutics, Inc. (NASDAQ: CLDX) announced today that final data ... tumors, including long-term patient follow-up, have been published in ... The data demonstrate robust antibody and T cell responses ... advanced cancers and suggest that CDX-1401 may predispose patients ...
(Date:4/16/2014)... DOWNERS GROVE, Ill. April 16, 2014 According ... surveillance colonoscopy in average-risk patients with one to two ... 90 percent of cases. This may be an appropriate ... endoscopic database study to quantify adherence to guidelines for ...
(Date:4/15/2014)... Cases of diabetes and pre-diabetes in the United States have ... Hopkins Bloomberg School of Public Health, with obesity apparently to ... burden of the disease has not hit all groups equally, ... elderly. , According to new research reported in the April ...
(Date:4/15/2014)... solved a decades-old medical mystery and in the process have ... which kill about 1.5 million people a year. The researchers say ... drug that has been in use for more than 50 years ... as it is to the microbes it attacks. , A ...
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