scholarly journals Signal detection on spontaneous reports of adverse events following immunisation: a comparison of the performance of a disproportionality‐based algorithm and a time‐to‐onset‐based algorithm

2013 ◽  
Vol 23 (2) ◽  
pp. 178-185 ◽  
Author(s):  
Lionel Holle ◽  
Vincent Bauchau
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Spontaneous Reports ◽  
Time To Onset

scholarly journals One size does not fit all: a summary of signal detection methods

2021 ◽  
Vol 2 (3) ◽  
pp. 4-6
Author(s):  
Dr. Rajrajeshwari R. Patil ◽  
Dr. Vivek Singh
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Health Care Professionals ◽  
Quantitative Methods ◽  
Detection Methods ◽  
Universal Method ◽  
Spontaneous Reports ◽  
Safety Alert ◽  
The Right ◽  
Safety Signals

The selection of an appropriate signal detection method is pivotal in the identification process of safety signals in pharmacovigilance. Nevertheless, the early detection of safety signals is even more important to prevent the occurrence of another thalidomide tragedy in humans. Spontaneous reports, follow-up studies, scientific literature, preclinical & clinical studies, are valuable sources of adverse events; but on the other hand, these reported adverse events are extremely diverse, hence comprehending this can result in formulating the right signal detection and evaluation strategies. Broadly, signal detection methods fall into two categories: qualitative and quantitative, each having its significance; while the quantitative methods help to handle the voluminous data during signal detection, the qualitative one does its part to pick the rare signals. Hence, there is no single universal method that would be a perfect fit to identify safety signals from all data sources or for all types of adverse events. Further, the signal detection process involves a series of steps right from signal detection to its final assessment & submission, to regulatory authorities confirming a signal as a 'possible safety alert'. Finally, the completed task of finding a confirmed safety alert would be meaningless if it does not reach the end-users of the drug concerned. Therefore, effective communication to health care professionals, patients including clinical trial subjects, pharmaceutical companies, and other stakeholders is equally important.

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

scholarly journals Programmed cell death-1 and programmed cell death ligand-1 antibodies-induced dysthyroidism

2018 ◽  
Vol 7 (5) ◽  
pp. R196-R211 ◽  
Author(s):  
Jaafar Jaafar ◽  
Eugenio Fernandez ◽  
Heba Alwan ◽  
Jacques Philippe
Keyword(s):  
Clinical Trials ◽  
Cell Death ◽  
Programmed Cell Death ◽  
Adverse Events ◽  
English Language ◽  
Case Series ◽  
Immune Checkpoints ◽  
Pubmed Database ◽  
Programmed Cell Death 1 ◽  
Time To Onset

Background Monoclonal antibodies blocking the programmed cell death-1 (PD-1) or its ligand (PD-L1) are a group of immune checkpoints inhibitors (ICIs) with proven antitumor efficacy. However, their use is complicated by immune-related adverse events (irAEs), including endocrine adverse events (eAEs). Purpose We review the incidence, time to onset and resolution rate of dysthyroidism induced by PD-1/PD-L1 Ab, and the clinical, biological and radiological findings. We aim to discuss the potential mechanisms of PD-1/PD-L1 Ab-induced dysthyroidism, and to propose a management algorithm. Methods We performed a literature search of available clinical trials regarding PD-1/PD-L1 Ab in the PubMed database. We selected all English language clinical trials that included at least 100 patients. We also present selected case series or reports, retrospective studies and reviews related to this issue. Findings In patients treated with PD-1 Ab, hypothyroidism occurred in 2–10.1% and hyperthyroidism occurred in 0.9–7.8%. When thyroiditis was reported separately, it occurred in 0.34–2.6%. Higher rates were reported when PD-1 Ab were associated with other ICI or chemotherapy. The median time to onset of hyperthyroidism and hypothyroidism after PD-1 Ab initiation was 23–45 days and 2–3.5 months, respectively. Regarding PD-L1 Ab, hypothyroidism occurred in 0–10% and hyperthyroidism in 0.5–2% of treated patients. The average time to onset of dysthyroidism after PD-L1 Ab was variable and ranged from 1 day after treatment initiation to 31 months. Conclusion Dysthyroidism occurs in up to 10% of patients treated with PD-1/PD-L1 Ab. Hypothyroidism and reversible destructive thyroiditis are the most frequent endocrine adverse events (eAE) in PD-1/PD-L1 treated patients. Immune and non-immune mechanisms are potentially involved, independently of the presence of thyroid antibodies.

Comprehensive Analysis of Bortezomib-Induced Adverse Events Using the Japanese Real-World Database

Oncology ◽  
2021 ◽  
Author(s):  
Aya Satoki ◽  
Mayako Uchida ◽  
Masaki Fujiwara ◽  
Yoshihiro Uesawa ◽  
Tadashi Shimizu
Keyword(s):  
Peripheral Neuropathy ◽  
Adverse Events ◽  
Cardiac Failure ◽  
Tumor Lysis Syndrome ◽  
Adverse Event Reporting System ◽  
Japanese Patients ◽  
Comprehensive Analysis ◽  
Drug Event ◽  
Lung Disorder ◽  
Time To Onset

Background: Bortezomib is used as first-line therapy for multiple myeloma. Observational studies based on the FDA Adverse Event Reporting System (FAERS) database analysis and systematic reviews indicate that the incidence of peripheral neuropathy and tumor lysis syndrome (TLS) tends to be higher with bortezomib than that of other drugs. In a comprehensive analysis assessing drugs that cause peripheral neuropathy in Japanese patients, the incidence of bortezomib-induced adverse events (AEs) was reportedly high. However, a comprehensive assessment of bortezomib is lacking. Objectives: The purpose of this study was to determine the frequency of bortezomib AEs in Japanese patients and to determine the incidence, time to onset, and post hoc outcomes of unique AEs using the Japanese Adverse Drug Event Report (JADER) database. Method: To investigate the association between bortezomib and AEs, we analyzed the JADER database, which contains spontaneous AE reports submitted to the Pharmaceuticals and Medical Devices Agency from April 2004 to December 2020. Criteria indicating the presence of an AE signal were met when the following requirements were fulfilled: proportional reporting ratios (PRR) ≥ 2 and χ2 ≥ 4. Time to onset and post-event outcomes were analyzed for characteristic AEs. Results: Among 26 extracted AEs, 13 presented AE signals. The post-exposure outcomes of 12 AEs showed fatal outcomes at rates exceeding 10%, including cardiac failure (30%), lung disorder (24%), pneumonia (18%), and TLS (10%). Furthermore, a histogram of time to onset revealed that the 12 AEs were concentrated from the beginning to approximately one month after bortezomib administration. The median onset times for cardiac failure, lung disorder, pneumonia, and TLS were 28, 13, 42, and 5 days, respectively. Conclusions: Cardiac failure, lung disorder, pneumonia, and TLS had a higher rate of fatal clinical outcomes after onset than other AEs. These AEs exhibited a greater onset tendency in the early post-dose period. This study suggests that there is a need to monitor signs of cardiac failure, lung disorder, pneumonia, and TLS, potentially resulting in serious outcomes.

Safety of cenobamate as adjunctive therapy in adults with uncontrolled focal seizures: Time to onset, duration, and severity of the most common adverse events

2021 ◽  
Vol 429 ◽  
pp. 119099
Author(s):  
Gabriele Camattari ◽  
Bernhard Steinhoff ◽  
Elinor Ben-Menachem ◽  
Christian Brandt ◽  
Irene García Morales ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adjunctive Therapy ◽  
Focal Seizures ◽  
Time To Onset
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