We conducted a post-marketing surveillance to evaluate the safety and efficacy of TKN732, approved as "filgrastim biosimilar 2", in Japanese patients who developed neutropenia in the course of cancer chemotherapy or hematopoietic stem cell transplantation. A total of 653 patients were registered during the 2-year enrollment period starting from May 2013, and 627 and 614 patients were eligible for safety and efficacy analyses of the G-CSF biosimilar, respectively. Forty-three adverse drug reactions were reported in 33 patients (5.26%). Back pain was most frequently observed and reported in 20 patients (3.19%), followed by pyrexia (1.28%) and bone pain (0.96%). Risk factors for adverse reactions identified by logistic regression analyses were younger age, presence of past medical history, and lower total dose at the onset of adverse reactions. Among the 576 cancer patients who developed Grade 2-4 neutropenia after chemotherapy, recovery to Grade 1/0 was reported in 553 patients (96%) following filgrastim biosimilar 2 treatment. The median duration of neutrophil counts below 1500/μL was 5 days. In addition, all 11 patients who underwent hematopoietic stem cell transplantation had good responses to filgrastim biosimilar 2. In conclusion, this study showed that filgrastim biosimilar 2 has a similar safety profile and comparable effects to the original G-CSF product in the real world clinical setting.
Abstract13C‐NMR spectroscopy was used in a detailed study of vinyl chloride‐vinyl acetate and vinyl chloride‐vinyl propionate copolymers. The NMR spectra of the methylene carbon region showed three split peaks whose intensities changed with composition of the copolymers. These peaks were assigned to diad sequences and the observed diad concentrations were in good agreement with the calculated concentrations in terms of the random copolymerization theory. For the methine carbon spectra of vinyl acetate or vinyl propionate units in the copolymers the degree of splitting of the signal was improved by the addition of tris(1,1,1,2,2,3,3‐heptafluro‐7,7‐diemthyl‐1,4,6‐octanedinata)‐praseodymium as a shift reagent. Four peaks assigned to the methine carbon were interpreted in terms of triad sequence distribution and tacticity.
This paper describes a speaker recognition model using TDMC and self-growing LVQ. Two-dimensional mel-cepstrum (TDMC) consists of averaged and dynamic spectral features of the two-dimensional mel-log spectra in the analyzed interval. A self-growing algorithm is used for VQ. In the beginning of this algorithm, there is no centroid and the first input feature vector is set to the first centroid. Then an input vector is classified into a specified centroid. When the amount of data in the centroid becomes greater than a predetermined threshold, the centroid is divided into two so that each centroid has the same number of data. By these procedures the number of centroids increases gradually while the amount of the data in each centroid become almost equal. In this study, text-dependent speaker identification experiments for 30 speakers were carried out. Each speaker recorded 10 digits three times during five sessions. Each speaker model is created using the speech data of two sessions. The area, the number of centroids, and a combination of averaged and dynamic features of TDMC were studied. The experimental results have shown that the combination of averaged and dynamic features is very effective and the proposed model gives an averaged identification score of 95%.
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