Potential safety signals with biologic use identified

2018 ◽  
Vol 1707 (1) ◽  
pp. 9-9
Keyword(s):  
Potential Safety ◽  
Safety Signals

Re-using Mini-Sentinel data following rapid assessments of potential safety signals via modular analytic programs

2013 ◽  
Vol 22 (10) ◽  
pp. 1036-1045 ◽  
Author(s):  
Sengwee Toh ◽  
Jerry Avorn ◽  
Ralph B. D'Agostino ◽  
Jerry H. Gurwitz ◽  
Bruce M. Psaty ◽  
...  
Keyword(s):  
Potential Safety ◽  
Safety Signals

Drug safety profiling for assessment of drug combinations in oncology

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15037-15037
Author(s):  
S. N. Voss ◽  
A. Czarnecki
Keyword(s):  
Ovarian Cancer ◽  
Drug Safety ◽  
Gastrointestinal Disorders ◽  
Safety Database ◽  
New Drug ◽  
Combination Treatments ◽  
Potential Safety ◽  
Drug Regimens ◽  
Safety Signals ◽  
System Organ

15037 Background: It is important to understand the safety profile (SP)/toxicity of new drug regimens in oncology. We compared SPs of gemcitabine (Gem) + carboplatin (Carbo) in NSCLC with Gem alone and in different combinations and also tested the methodology of drug safety profiling (DSP). Methods: Spontaneous cases for the period of 1995–2005 were reviewed on the Lilly Safety Database (LSD). DSP was used to evaluate differences in the SPs of several combinations: Gem+Carbo in NSCLC, Gem+Carbo in ovarian cancer, Gem+ cisplatin (Cis) in NSCLC, Gem+Carbo in all indications, and Gem regardless of treatment regimen, for all indications. Frequencies of adverse events (AEs) for all MedDRA System Organ Classes (SOCs) were used for each regimen. In addition, the MedDRA Preferred Terms (PTs) were reviewed to detect potential safety signals. The numbers of AEs in different SOCs were assessed as proportions of the total reports for the Gem combinations in the LSD. Results: With the exception of the Investigations SOC, the proportions of AEs for patients treated for NSCLC with Gem+Carbo were consistent with those for patients treated for NSCLC with Gem+Cis and with Gem for all indications. However, the frequency in the Investigations SOC was consistent with that reported for Gem+Carbo in all indications (14.2% v. 12.0%). A greater frequency of AEs was seen in the Gastrointestinal Disorders SOC for patients treated with Gem+Carbo for ovarian cancer compared to patients treated with Gem+Carbo for NSCLC. The review of individual PTs for Gem+Carbo did not reveal any safety signals. Conclusions: The SP of Gem+Carbo in NSCLC using DSP showed similar patterns to all other Gem combinations with only some differences due to the indication. DSP is a useful tool in assessing the new drug combination treatments in existing or new indications. [Table: see text]

scholarly journals Early evidence for the safety of certain COVID-19 vaccines using empirical Bayesian modeling from VAERS

2021 ◽  
Author(s):  
Chris von Csefalvay
Keyword(s):  
Bayesian Modeling ◽  
Vaccination Campaign ◽  
Empirical Bayesian ◽  
Global Response ◽  
Early Evidence ◽  
Potential Safety ◽  
Mass Vaccination Campaign ◽  
Gamma Poisson Shrinker ◽  
The U.S ◽  
Safety Signals

The advent of vaccines against SARS-CoV-2 ushered in an unprecedented global response to COVID-19, with the largest and most ambitious mass vaccination campaign in human history. The scale of this effort means that safety signals suggesting adverse effects may only be detectable using passive reporting. This paper examines reports to the CDC/FDA's VAERS system in the first six months of 2021, using an empirical Bayesian model with a gamma Poisson shrinker to identify potential safety signals from COVID-19 vaccines currently on the U.S. market. Based on this preliminary data, it is concluded that the COVID-19 vaccine's safety significantly exceeds that of previously marketed vaccines, and other than a known risk of thrombotic events, no safety signals of concern emerge.

scholarly journals Potential Safety Signals and Their Significance

2012 ◽  
Vol 172 (1) ◽  
pp. 72 ◽  
Author(s):  
Abbey Powers ◽  
G. Elliott Cook
Keyword(s):  
Potential Safety ◽  
Safety Signals

scholarly journals Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database

2021 ◽  
Vol 12 ◽  
Author(s):  
Marion Allouchery ◽  
Cécile Tomowiak ◽  
Thomas Lombard ◽  
Marie-Christine Pérault-Pochat ◽  
Francesco Salvo
Keyword(s):  
Safety Profile ◽  
Large Scale ◽  
Reference Group ◽  
Heart Diseases ◽  
Proportional Reporting Ratio ◽  
World Health ◽  
Safety Database ◽  
Potential Safety ◽  
Pharmacovigilance Database ◽  
Safety Signals

As ibrutinib has become a standard of care in B-cell malignancies in monotherapy or in combination with other agents, definition of its safety profile appears essential. The aim of this study was to further characterize the safety profile of ibrutinib through the identification of potential safety signals in a large-scale pharmacovigilance database. All serious individual case safety reports (ICSRs) in patients aged ≥18 years involving ibrutinib suspected in the occurrence of serious adverse drug reactions or drug interacting from November 13th, 2013 to December 31st, 2020 were extracted from VigiBase, the World Health Organization global safety database. Disproportionality reporting was assessed using the information component (IC) and the proportional reporting ratio (PRR), with all other anticancer drugs used as the reference group. To mitigate the confounding of age, two subgroups were considered: patients aged<75 years and ≥75 years. A signal of disproportionate reporting (SDR) was defined if both IC and PRR were significant. A total of 16,196 ICSRs were included. The median age of patients was 72.9 years, 42.6% of ICSRs concerned patients aged ≥75 years, and 64.2% male patients. More than half (56.2%) of ICSRs resulted in hospitalization or prolonged hospitalization. Among 713 SDRs, 36 potential safety signals emerged in ibrutinib-treated patients, mainly ischemic heart diseases, pericarditis, uveitis, retinal disorders and fractures. All potential safety signals having arisen in this analysis may support patient care and monitoring of ongoing clinical trials. However, owing to the mandatory limitations of this study, our results need further confirmation using population-based studies.

An innovative prone positioning system for advanced deformity and frailty in complex spine surgery

2020 ◽  
Vol 32 (2) ◽  
pp. 229-234
Author(s):  
Benjamin Kolb ◽  
John Large ◽  
Stuart Watson ◽  
Glyn Smurthwaite
Keyword(s):  
Ankylosing Spondylitis ◽  
Three Dimensional ◽  
Technical Note ◽  
Positioning System ◽  
Prone Positioning ◽  
Economic Implications ◽  
Potential Safety ◽  
Chest Deformity ◽  
Positioning Device ◽  
Skin Quality

The authors present a technical note for a prone positioning system developed to facilitate cervical extension osteotomy for ankylosing spondylitis in the presence of severe deformity and frailty. Chin-on-chest deformity represents one of the most debilitating changes of ankylosing spondylitis. Where the chin-brow angle approaches or exceeds 90°, prone positioning becomes problematic due to the fixed position of the head. Furthermore, the challenge is compounded where physiological deconditioning leads to frailty, and the side effects of medical therapies decrease muscle mass and skin quality. Conventional prone positioning equipment is not able to cater to all patients. A versatile system was developed using a 3D reconstruction to enable a positioning simulation and verification tool. The tool was used to comprehensively plan the perioperative episode, including spatial orientation and associated equipment. Three-dimensional printing was used to manufacture a bespoke positioning device that precisely matched the contours of the patient, reducing contact pressure and risk of skin injury. The authors were able to safely facilitate surgery for a patient whose deformity and frailty may otherwise have precluded this possibility. The system has potential safety and economic implications that may be of significant utility to other institutions engaging in complex spinal surgery.

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