On Construction of Safety Signal Automata for $MITL[\:\mathcal{U},\:\mathcal{S}]$ Using Temporal Projections

2011 ◽  
pp. 225-239 ◽  
Author(s):  
Dileep Raghunath Kini ◽  
Shankara Narayanan Krishna ◽  
Paritosh K. Pandya
Keyword(s):  
Safety Signal

Federal Advisory Panel Finds No Safety Signal With Vaccine

2010 ◽  
Vol 44 (2) ◽  
pp. 16
Author(s):  
MIRIAM E. TUCKER
Keyword(s):  
Advisory Panel ◽  
Safety Signal

A Safety Signal of Somnambulism with the Use of Antipsychotics and Lithium: A Pharmacovigilance Disproportionality Analysis

2020 ◽  
Author(s):  
Amandine Gouverneur ◽  
Amandine Ferreira ◽  
Camille Morival ◽  
Cécile Pageot ◽  
Marie Tournier ◽  
...  
Keyword(s):  
Safety Signal ◽  
Disproportionality Analysis

scholarly journals Safety of switching between rituximab biosimilars in onco-hematology

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Silvana A. M. Urru ◽  
Stefania Spila Alegiani ◽  
Anna Guella ◽  
Giuseppe Traversa ◽  
Annalisa Campomori
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Adverse Events ◽  
Prospective Observational Study ◽  
Randomized Trials ◽  
Lymphocytic Leukemia ◽  
Safety Signal ◽  
Efficacy And Safety ◽  
Clinical Safety ◽  
Study Population ◽  
Grade 3

AbstractComparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between different biosimilars. In this prospective observational study we aimed at evaluating the safety of switching between reference and biosimilar rituximab (TRUXIMA and RIXATHON) at Trento General Hospital (Italy). All patients (n = 83) with Non Hodgkin’s Lymphoma (NHL, n = 72) and Chronic Lymphocytic Leukemia (CLL, n = 11) who received rituximab between March 2018 and March 2019 were asked to take part in the study. In 2017 and 2018 two tenders were carried out and two different biosimilars became available in the hospital, these were used sequentially. Thus, patients with or without previous treatments with the originator rituximab either received a biosimilar or were switched between different biosimilars. The incidence of adverse events in these groups of patients is described. The study population received 465 rituximab infusions and all received biosimilars. Fifty patients (60%) experienced at least one switch between different biosimilars or between rituximab originator and biosimilar, whereas 33 (40%) received one of the two biosimilars and one patient received reference rituximab. Adverse events (n = 146) were reported in 71 patients (84.5%). Treatment-related grade 3–4 events were reported in 5 patients (5.9%), whereas grade 1 rituximab related infusion events were observed in 6 patients (7.1%). No safety signal emerged in association with the use of a specific biosimilar nor with the practice of switching. Adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of rituximab biosimilars.

scholarly journals Longitudinal medical records as a complement to routine drug safety signal analysis

2015 ◽  
Vol 24 (5) ◽  
pp. 486-494 ◽  
Author(s):  
Kristina Star ◽  
Sarah Watson ◽  
Lovisa Sandberg ◽  
Jeanette Johansson ◽  
I. Ralph Edwards
Keyword(s):  
Drug Safety ◽  
Medical Records ◽  
Signal Analysis ◽  
Safety Signal

Effects of fear-relevance on electrodermal safety signal learning

1989 ◽  
Vol 28 (2) ◽  
pp. 89-104 ◽  
Author(s):  
Gary M. Wilkinson ◽  
Peter F. Lovibond ◽  
David A.T. Siddle ◽  
Nigel Bond
Keyword(s):  
Safety Signal

safety signal

2000 ◽  
pp. 1511-1511
Author(s):  
Martin H. Weik
Keyword(s):  
Safety Signal

scholarly journals Appendicitis as a possible safety signal for the COVID-19 vaccines

Vaccine X ◽  
2021 ◽  
pp. 100122
Author(s):  
Joseph Mitchell ◽  
Qun-Ying Yue
Keyword(s):  
Safety Signal

Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database

2018 ◽  
Vol 27 (11) ◽  
pp. 1249-1256 ◽  
Author(s):  
Caitlin Dodd ◽  
Alexandra Pacurariu ◽  
Osemeke U. Osokogu ◽  
Daniel Weibel ◽  
Carmen Ferrajolo ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Safety Signal ◽  
Pediatric Drug
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