National registry of thoracoamniotic shunting using a double‐basket catheter: A post‐marketing surveillance registry of 295 patients with fetal hydrothorax
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DOI: 10.1002/pd.6587
Abstract: We report on the 1‐year outcomes of fetuses who underwent thoracoamniotic shunting (TAS) with a double‐basket catheter for fetal hydrothorax (FHT) using a national post‐marketing surveillance registry. read more here.
Keywords: basket catheter; double basket; registry; post marketing ... See more keywords
Real-world safety and effectiveness of nivolumab for advanced renal cell carcinoma in Japan: a post-marketing surveillance
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DOI: 10.1007/s10147-022-02155-3
Abstract: This all-case post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab monotherapy in Japanese patients with un-resectable or metastatic renal cell carcinoma (RCC). This multicenter, open-label, non-interventional, observational PMS study (registered from August… read more here.
Keywords: safety effectiveness; post marketing; marketing surveillance; real world ... See more keywords
Safety of nivolumab monotherapy in five cancer types: pooled analysis of post-marketing surveillance in Japan
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DOI: 10.1007/s10147-024-02515-1
Abstract: Nivolumab has been approved for treating ≥ 10 cancer types. However, there is limited information on the incidence of rare, but potentially serious, treatment-related adverse events (TRAEs), as well as notable TRAEs in patients with certain… read more here.
Keywords: cancer; safety nivolumab; post marketing; cancer types ... See more keywords
Isatuximab with pomalidomide-dexamethasone in relapsed/refractory multiple myeloma: post-marketing surveillance in Japan
Sign Up to like & getrecommendations! Published in 2024 at "International Journal of Hematology"
DOI: 10.1007/s12185-024-03800-5
Abstract: This post-marketing surveillance assessed the safety and effectiveness of isatuximab plus pomalidomide and dexamethasone (Isa-Pd) for relapsed or refractory multiple myeloma (RRMM) during real-world use in Japan. Data from 211 individuals with RRMM treated with… read more here.
Keywords: marketing surveillance; post marketing; refractory multiple; relapsed refractory ... See more keywords
Venetoclax treatment for chronic lymphocytic leukemia/small lymphocytic leukemia in Japan: post-marketing surveillance
Sign Up to like & getrecommendations! Published in 2024 at "International Journal of Hematology"
DOI: 10.1007/s12185-024-03832-x
Abstract: Venetoclax was approved for relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and small lymphocytic leukemia (SLL) in Japan in September 2019; however, clinical data in Japanese patients are limited. This all-case post-marketing surveillance assessed efficacy and… read more here.
Keywords: small lymphocytic; chronic lymphocytic; post marketing; japan ... See more keywords
A Post-Marketing Surveillance Study of Nusinersen for Spinal Muscular Atrophy in Routine Medical Practice in China: Interim Results
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DOI: 10.1007/s12325-024-02852-7
Abstract: Spinal muscular atrophy (SMA) is a rare, autosomal recessive, neuromuscular disease that leads to progressive muscular weakness and atrophy. Nusinersen, an antisense oligonucleotide, was approved for SMA in China in February 2019. We report interim… read more here.
Keywords: spinal muscular; interim results; muscular atrophy; post marketing ... See more keywords
Safety of Secukinumab from 1 Million Patient-Years of Exposure: Experience from Post-Marketing Setting and Clinical Trials
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DOI: 10.1007/s13555-024-01122-2
Abstract: Secukinumab is an anti-interleukin (IL)-17A monoclonal antibody indicated for multiple immunological disorders. Here, we aim to summarize secukinumab safety in clinical trials (CTs) and post-marketing setting (PMS) until 25 June 2022. Adverse events (AEs) were… read more here.
Keywords: post marketing; safety; marketing setting; clinical trials ... See more keywords
Acetyl-cholinesterase-inhibitors reconsidered. A narrative review of post-marketing studies on Alzheimer’s disease
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DOI: 10.1007/s40520-023-02675-6
Abstract: The real efficacy of Acetyl-cholinesterase-inhibitors (AChEI) has been questioned. In this narrative review we evaluated their effect on cognitive decline, measured by Mini Mental State Examination (MMSE), and on total mortality rates in patients with… read more here.
Keywords: alzheimer disease; disease; acetyl cholinesterase; cholinesterase inhibitors ... See more keywords
Safety and effectiveness of oral blonanserin for schizophrenia: A review of Japanese post-marketing surveillances.
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DOI: 10.1016/j.jphs.2020.09.006
Abstract: Schizophrenia significantly limits social functioning with positive and negative symptoms and cognitive dysfunction. Blonanserin (LONASEN®), a novel second-generation antipsychotic approved for treating schizophrenia in Japan in 2008, reportedly shows beneficial effects on cognitive function as… read more here.
Keywords: schizophrenia; japanese post; post marketing; blonanserin ... See more keywords
Guidance for the governance of public-private collaborations in vaccine post-marketing settings in Europe.
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DOI: 10.1016/j.vaccine.2019.04.073
Abstract: INTRODUCTION The 2009 influenza pandemic highlighted challenges for vaccine post-marketing monitoring in Europe, particularly the need to have appropriate infrastructures to strengthen public-private collaborations (PPCs) with suitable processes to improve stakeholder interactions and collection and… read more here.
Keywords: public private; post marketing; governance; vaccine post ... See more keywords
Post-marketing safety surveillance for inactivated Enterovirus 71 vaccines in Jiangsu, China from 2017 to 2019.
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DOI: 10.1016/j.vaccine.2021.01.048
Abstract: INTRODUCTION Two types of enterovirus 71 (EV71) vaccines, manufactured using human diploid (H2) and Vero cells, have been administered in Jiangsu Province, China since 2017. In this study, we evaluated their safety profiles using records… read more here.
Keywords: safety; marketing safety; post marketing; china ... See more keywords