Post-Marketing Surveillance Study
Safety and efficacy of Rapamune® (Sirolimus) in kidney transplant recipients: results of a prospective post-marketing surveillance study in Korea
... present study has some limitations. First, this study was an observational post-marketing surveillance study to satisfy the requirements of the ...this study is an ...
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Post-Marketing Surveillance Study to Assess S-Pantoprazole Induced Clinical Effectiveness (SPICE-Study)
... a post marketing surveillance (PMS) study conducted to assess the safety and efficacy of S-Pantoprazole 20 mg tablets in patients with gastroesophageal reflux disease (GERD) and/or peptic ...
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Multicenter, noninterventional, post-marketing surveillance study to evaluate dosing of recombinant human follicle-stimulating hormone using the redesigned follitropin alfa pen in women undergoing ovulation induction
... noninterventional, post-marketing surveillance study found that monofollicular or bifollicular development was achieved in 71% of the women who received r-hFSH using the redesigned follitropin ...
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Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: post-marketing surveillance study report
... a study confirming the effect in preventing the recurrence/relapse of mood episodes in patients with bipolar I disorder (BDI) suggested that lamotrigine significantly prolonged the time to recur- rence/relapse of ...
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Post-marketing surveillance study of the safety of dexamethasone intravitreal implant in patients with retinal vein occlusion or noninfectious posterior segment uveitis
... observational, post-authorization safety study conducted from March 2012 to March 2016 at 102 sites in France, Germany, Spain, and the ...The study was carried out in accordance with the tenets of ...
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Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch<sup>® </sup>capsules 2.5 μg) in 3,762 hemodialysis patients with intractable pruritus
... Preceding clinical trials had noted one patient who experienced temporary gynecomastia. This surveillance also found four patients with gynecomastia, urging suf- ficient attention to increased levels of serum ...
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Incidence and predictors of hypoglycemia in Japanese patients with type 2 diabetes treated by insulin glargine and oral antidiabetic drugs in real-life: ALOHA post-marketing surveillance study sub-analysis
... ADVANCE study, history of microvascular disease was associated with twofold increase in risk of severe hypoglycemia (hazards ratio ...current study also, hypoglycemia was associated with presence of ...
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Effects and safety profile of betahistine in patients in the Russian contingent of OSVaLD, an open-label observational study in vestibular vertigo
... open-label, post-marketing surveillance study of the response to betahistine 48 mg/day in vertigo of peripheral vestibular origin carried out in a total of 13 ...comes Study Short-Form ...
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AN OPEN LABELED, MULTICENTRIC, POST MARKETING SURVEILLANCE (PMS) TO SUBSTANTIATE THE SAFETY AND EFFICACY OF SINAREST SYRUP IN PATIENTS OF COMMON COLD
... Background: The common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and ...
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A data-capture system for post-marketing surveillance of drugs that integrates with hospital electronic health records
... Kyoto University Hospital launched an EHR system in January 2005. At the same time, a replicate of that database, known as Open DB, was established for other purposes. Using Open DB, we developed a combined cancer ...
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Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review
... Our study highlights that a systematic review of the published and grey literature as a method to identify po- tential safety issues or ruptures associated with the use of PTCA catheters in patients with CAD is ...
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Long term safety of secukinumab in patients with moderate to severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis: integrated pooled clinical trial and post marketing surveillance data
... of study medication, with data pooled at the indi- vidual patient level for all secukinumab treatment groups (any secukinumab) separately for the studies by ...
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Adverse Drug Reactions of Cardiovascular Drugs in Intensive Cardiac Care Unit in a Tertiary Care Hospital: A Prospective Study
... pre- marketing trials and post marketing surveillance and increased usage of cardiovascular drugs made the need for the present ...this study was conducted to monitor and to analyze the ...
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Post-marketing surveillance data of thrombomodulin alfa: sub-analysis in patients with sepsis-induced disseminated intravascular coagulation
... The data of patients re-treated with TM-α were ex- cluded from this analysis. TM-α was administered by intravenous infusion for 30 min once a day at a dose of 380-U/kg body weight [7]. Since TM-α is excreted by the ...
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Pharmacovigilance System in Bangladesh: A Regulatory Perspective
... conduct post- marketing surveillance activities; Suspected adverse reactions to drugs must be reported using the electronic version of the reporting form available in the fillable pdf on DGDA website ...
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Post marketing safety surveillance and re evaluation of Xueshuantong injection
... this study has been successfully used in our previous post-marketing safety surveillance of Danhong injec- ...our study contributed greatly to improve objectivity of results and ...
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Post marketing surveillance of anti malarial medicines used in Malawi
... the study suggest a widespread use of sub- standard anti-malarial medicines throughout the country with respect to API ...The post-marketing surveillance and pharmacovigilance sys- tem has ...
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A comprehensive study on regulatory requirements for registration of vaccines in usa, europe and canada
... USA, Marketing authorization application (MAA) in Europe and New Drug Submission (NDS) Application in Canada should be ...vaccine, post-marketing surveillance system such as Vaccine Adverse ...
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Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers
... Results: The study included 1788 patients with 1835 DFU (81% Wagner ’ s grades 3 or 4; 43% ischemic) treated from May 2007 to April 2010. Complete granulation was observed in 76% of the ulcers in 5 weeks (median). ...
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... In the second part, the paper focuses on the Italian social security system immediately after World War II. We emphasize the preponderance of the elements of continuity between the corporative welfare state built up by ...
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