Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database

[1]  C. Kessler,et al.  Emicizumab for the Treatment of Acquired Hemophilia a: A Multicenter US Case Series , 2021, Blood.

[2]  K. Meijer,et al.  A boy with joint pain associated with emicizumab treatment: The importance of plasma level measurement , 2020, Haemophilia : the official journal of the World Federation of Hemophilia.

[3]  S. Kitchen,et al.  Effects of emicizumab on APTT, one‐stage and chromogenic assays of factor VIII in artificially spiked plasma and in samples from haemophilia A patients with inhibitors , 2020, Haemophilia : the official journal of the World Federation of Hemophilia.

[4]  J. Oldenburg,et al.  A multicenter, open-label, phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. , 2019, Blood.

[5]  C. Hermans,et al.  Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study. , 2019, The Lancet. Haematology.

[6]  M. Streiff,et al.  Successful use of emicizumab in a patient with refractory acquired hemophilia A and acute coronary syndrome requiring percutaneous coronary intervention , 2019, Research and practice in thrombosis and haemostasis.

[7]  L. Valentino,et al.  Emicizumab: Review of the literature and critical appraisal , 2018, Haemophilia : the official journal of the World Federation of Hemophilia.

[8]  J. Oldenburg,et al.  Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors , 2018, The New England journal of medicine.

[9]  J. Reichert,et al.  Antibodies to watch in 2018 , 2018, mAbs.

[10]  O. Christophe,et al.  Emicizumab, a bispecific antibody recognizing coagulation factors IX and X: how does it actually compare to factor VIII? , 2017, Blood.

[11]  N. Kotani,et al.  A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A , 2017, Clinical Pharmacokinetics.

[12]  J. Oldenburg,et al.  Emicizumab Prophylaxis in Hemophilia A with Inhibitors , 2017, The New England journal of medicine.

[13]  Yongfang Hou,et al.  Exploration of statistical shrinkage parameters of disproportionality methods in spontaneous reporting system of China , 2015, Pharmacoepidemiology and drug safety.

[14]  J. Mahlangu,et al.  Guidelines for the management of hemophilia , 2013, Haemophilia : the official journal of the World Federation of Hemophilia.

[15]  D. Lewandowski,et al.  Validity of assessing inhibitor development in haemophilia PUPs using registry data: the EUHASS project , 2012, Haemophilia : the official journal of the World Federation of Hemophilia.

[16]  Johan Hopstadius,et al.  Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery , 2011, Statistical methods in medical research.

[17]  W. DuMouchel,et al.  Novel Statistical Tools for Monitoring the Safety of Marketed Drugs , 2007, Clinical pharmacology and therapeutics.

[18]  D. Wysowski,et al.  Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. , 2005, Archives of internal medicine.

[19]  Daisuke Koide,et al.  Comparison of data mining methodologies using Japanese spontaneous reports , 2004, Pharmacoepidemiology and drug safety.

[20]  D J Graham,et al.  The role of databases in drug postmarketing surveillance , 2001, Pharmacoepidemiology and drug safety.

[21]  E G Tuddenham,et al.  The hemophilias--from royal genes to gene therapy. , 2001, The New England journal of medicine.

[22]  A. Bate,et al.  A Bayesian neural network method for adverse drug reaction signal generation , 1998, European Journal of Clinical Pharmacology.

[23]  M. Lindquist,et al.  A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions , 2002, Pharmacoepidemiology and drug safety.