• efficacy
  • Other presentations demonstrate BLINCYTO ' s potential in a high risk subpopulation of patients with relapsed or refractory Philadelphia chromosome-positive (Ph+) B-precursor ALL (abstract #679) and confirm BLINCYTO's efficacy in a subset of patients with relapsed or refractory Philadelphia chromosome-negative (Ph-) ALL after an allogeneic hematopoietic stem cell transplantation (alloHSCT), who typically have poor outcomes with current therapies (abstract #861). (amgen.com)
  • A total of 1964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent open-label extension studies. (rxlist.com)
  • BIAL and Eisai also announced details of a new pan-European, pooled analyses of real-world safety and efficacy data for patients treated with adjunctive eslicarbazepine acetate, to complement evidence from clinical trials. (perssupport.nl)
  • The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients. (clinicaltrials.gov)
  • In fact, data derived from the French cohort CUPIC including HCV-monoinfected, cirrhotic patients, show that tolerability and efficacy of TVR and BOC-based treatment is lower than observed in pivotal trials. (clinicaltrials.gov)
  • monotherapy
  • In a Phase 2 confirmatory multicenter single-arm trial (BLAST), adult patients with B-cell precursor ALL with minimal residual disease (MRD) who received BLINCYTO monotherapy demonstrated clinically meaningful relapse-free survival (RFS), as measured in the key secondary endpoint (abstract #680). (amgen.com)
  • Data from an investigational Phase III study for adjunctive Zebinix(R) (eslicarbazepine acetate) in a monotherapy setting showed that eslicarbazepine acetate is non-inferior to controlled release (CR) carbamazepine in patients with newly diagnosed partial onset seizures. (perssupport.nl)
  • Cohort
  • Patients in the second dose cohort achieved peak FIX expression of 13%, 20%, and 12% at weeks 4, 8, and 8, respectively. (dimensiontx.com)
  • The findings in the low-dose cohort are comparable to results published by Nathwani et al in the New England Journal of Medicine (2011), where patients have had measurable levels of FIX for 3-5 years or more at last follow-up (Nienhuis et al . (dimensiontx.com)
  • In addition, none of the patients in Cohort 2 have required prophylactic or on-demand recombinant FIX transfusion for spontaneous bleeds post-dosing. (dimensiontx.com)
  • Preliminary Phase 1/2 findings from 2 patients in each of Cohort 1 and 2 prompted administration of a standard tapering course of corticosteroids to treat mild, asymptomatic elevations in ALTs (52-98 IU/L), similar to findings from multiple studies using other AAV serotypes, including AAV8 and AAV9. (dimensiontx.com)
  • The third patient in Cohort 2 also received corticosteroids, experiencing a peak ALT of 914 IU/L, and was at 431 IU/L at 6 weeks post-dosing. (dimensiontx.com)
  • We expect that Cohort 2 will continue to receive a standard tapering course of corticosteroid therapy and as of the January 28, 2017 data cutoff, 2 of 3 patients' ALT levels were in the normal range. (dimensiontx.com)
  • Cohort 1 patients were all clinically stable and off steroids with ALT levels in the normal range. (dimensiontx.com)
  • As required by the trial protocol, we have reported the ALT levels for patient 3 in Cohort 2 to the Data Safety Monitoring Committee (DSMC), the U.S. Food and Drug Administration ( FDA ), and the appropriate regulatory authorities and will await their feedback prior to initiating dosing of Cohort 3. (dimensiontx.com)
  • Phase
  • The safety of Toviaz was evaluated in Phase 2 and 3 controlled trials in a total of 2859 patients with overactive bladder , of which 2288 were treated with fesoterodine. (rxlist.com)
  • In the phase 1/2 study, patients received serotype AAVrh10 vector with a codon-optimized FIX gene expressing wild-type FIX protein. (dimensiontx.com)
  • 1980
  • A biotechnology pioneer since 1980, Amgen has reached millions of patients around the world. (amgen.com)
  • The first case report in which the shortening of the QT interval by primidone was documented, published in the July 1980 issue of Annals of Internal Medicine, involved three patients, a 31-year-old woman, her 15-year-old nephew, and his 16-year-old sister. (wikipedia.org)
  • severe
  • ZOSYN is a combination product consisting of a penicillin -class antibacterial , piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below. (rxlist.com)
  • cardiovascular
  • Subgroup analyses, including the assessment of elderly patients, comorbidities (such as depression and cardiovascular disease) and the preferred combinations of epilepsy treatments employed with eslicarbazepine acetate are also planned. (perssupport.nl)
  • blood
  • The most common grade 3 or 4 AEs seen in at least 10% of patients were fatigue, urinary tract infection, increased aspartate aminotransferase (AST) and increased blood CK. (arraybiopharma.com)
  • months
  • At 3 months, one patient in the cyclosporine group versus three in the control group were rehospitalized for heart failure (p = 0.28). (acc.org)
  • The primidone suppressed the fibrillations and lengthened the QT interval for two years and eight months in the patient. (wikipedia.org)
  • Mass
  • B M I = mass kg height m 2 = mass lb height in 2 × 703 {\displaystyle \mathrm {BMI} ={\frac {{\text{mass}}_{\text{kg}}}{{\text{height}}_{\text{m}}^{2}}}={\frac {{\text{mass}}_{\text{lb}}}{{\text{height}}_{\text{in}}^{2}}}\times 703} BMI provides a simple numeric measure of a person's thickness or thinness, allowing health professionals to discuss weight problems more objectively with their patients. (wikipedia.org)
  • trial
  • As part of the trial design, the primary analysis was based on a Blinded Independent Central Review (BICR) of patient scans, while results by local review at the investigative site were also analyzed. (biospace.com)
  • Approximately
  • Plasma clearance is significantly decreased and excretion in urine was significantly increased from approximately 30% to 50% in patients with biliary obstruction and cirrhosis. (drugs.com)
  • This combination prompt SVR only in approximately 50% of the HCV genotype 1 (HCV-1)-infected patients. (clinicaltrials.gov)
  • safety
  • On the other hand, similar to dual therapy including Peg-IFN/RBV, it is possible that both response rates and safety profiles of DAAs are not comparable between HCV-monoinfected and HIV/HCV-coinfected patients. (clinicaltrials.gov)
  • high
  • Metadoxine is a selective antagonist of the serotonin receptor subtype 5-HT2B and displays high affinity to the gamma-aminobutyric acid (GABA) transporter. (wikipedia.org)
  • activity
  • FIX activity was 5% and 8% in two patients at 12-weeks follow-up, and 7% for the third patient at 7 weeks. (dimensiontx.com)
  • We are encouraged by the apparent efficiency of gene transduction and the early trend we are seeing in sustained FIX activity across both cohorts with our wild-type FIX AAVrh10 vector in patients. (dimensiontx.com)
  • study
  • The non-inferiority study included 785 eligible patients (greater than or equal to18 years) with newly diagnosed partial-onset seizures, who were randomised to receive eslicarbazepine acetate or carbamazepine CR in a three-step dose-level design. (perssupport.nl)
  • The primary endpoint for the study was the proportion of patients with 26-week seizure freedom (non-inferiority difference margin of -12%) in the per-protocol (PP) population. (perssupport.nl)
  • disease
  • Achieving a complete minimal residual disease, or MRD response, is important because having no detectable MRD places ALL patients at a lower risk for relapse when compared to patients with persistent or recurrent MRD. (amgen.com)
  • The data presented are highly encouraging because they support the potential of BLINCYTO in a broader spectrum of ALL patients, including those at an earlier stage of disease. (amgen.com)
  • majority
  • A majority of the patients with myocardial dysfunction had concurrent hypertension which may have exacerbated cardiac dysfunction in patients at risk possibly by increasing cardiac afterload. (drugs.com)
  • data
  • We are collating data from over 17 real-world patient registries and clinical studies sponsored by Eisai and BIAL to provide a single source of information. (perssupport.nl)