scholarly journals Bias Correction of Risk Estimates in Vaccine Safety Studies With Rare Adverse Events Using a Self-controlled Case Series Design

2013 ◽  
Vol 178 (12) ◽  
pp. 1750-1759 ◽  
Author(s):  
C. Zeng ◽  
S. R. Newcomer ◽  
J. M. Glanz ◽  
J. A. Shoup ◽  
M. F. Daley ◽  
...  
Keyword(s):  
Adverse Events ◽  
Bias Correction ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Risk Estimates ◽  
Safety Studies

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design

2014 ◽  
Vol 56 (3) ◽  
pp. 513-525 ◽  
Author(s):  
Stanley Xu ◽  
Sophia Newcomer ◽  
Jennifer Nelson ◽  
Lei Qian ◽  
David McClure ◽  
...  
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Safety Studies

Use of the self-controlled case-series method in vaccine safety studies: review and recommendations for best practice

2011 ◽  
Vol 139 (12) ◽  
pp. 1805-1817 ◽  
Author(s):  
Y. G. WELDESELASSIE ◽  
H. J. WHITAKER ◽  
C. P. FARRINGTON
Keyword(s):  
Adverse Events ◽  
Best Practice ◽  
Good Practice ◽  
Case Series ◽  
Vaccine Safety ◽  
The Self ◽  
Series Method ◽  
Safety Studies ◽  
Definition Of ◽  
Study Designs

SUMMARYThe self-controlled case-series method was originally developed to investigate potential associations between vaccines and adverse events, and is now commonly used for this purpose. This study reviews applications of the method to vaccine safety investigations in the period 1995–2010. In total, 40 studies were reviewed. The application of the self-controlled case-series method in these studies is critically examined, with particular reference to the definition of observation and risk periods, control of confounders, assumptions and potential biases, methodological and presentation issues, power and sample size, and software. Comparisons with other study designs undertaken in the papers reviewed are also highlighted. Some recommendations are presented, with the emphasis on promoting good practice.

scholarly journals A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design

2013 ◽  
Vol 32 (19) ◽  
pp. 3290-3299 ◽  
Author(s):  
Stanley Xu ◽  
Simon J. Hambidge ◽  
David L. McClure ◽  
Matthew F. Daley ◽  
Jason M. Glanz
Keyword(s):  
Case Series ◽  
Vaccine Safety ◽  
Scan Statistic ◽  
Series Design ◽  
Safety Studies

Self-controlled case series design in vaccine safety: a systematic review

2021 ◽  
Author(s):  
Xiaolu Nie ◽  
Lu Xu ◽  
Yi Bai ◽  
Zuoxiang Liu ◽  
Zhike Liu ◽  
...  
Keyword(s):  
Systematic Review ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design

Adverse events associated with aprepitant pediatric bone cancer patients

2018 ◽  
Vol 25 (3) ◽  
pp. 735-738 ◽  
Author(s):  
Lucas M Okumura ◽  
Sacha A da Silva Ries ◽  
Clarice F Meneses ◽  
Mariana B Michalowski ◽  
Maria Angelica P Ferreira ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Adverse Events ◽  
Cancer Patients ◽  
Drug Information ◽  
Case Series ◽  
Bone Cancer ◽  
European Medicines Agency ◽  
Safety Studies ◽  
Official Sources

An eight-year long case series follow-up study with pediatric bone cancer patients was conducted to compare the occurrence of adverse events associated with aprepitant with official sources of drug information (manufacturer’s leaflet, clinical trials, and European Medicines Agency leaflet). All patients admitted were analyzed, representing 192 aprepitant cycles. Anorexia, febrile neutropenia, and headache were observed in frequencies over 43.8 per 100 patients, which was higher than previous estimates. Adverse events were classified as probable or possible, by using Naranjo score. The increased rates of adverse events, especially on the risk febrile neutropenia, warrant further safety studies on this population.

scholarly journals Olaparib dose re‐escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series

2021 ◽  
Vol 17 (S3) ◽  
pp. 3-11
Author(s):  
Siew‐Fei Ngu ◽  
Ka‐Yu Tse ◽  
Mandy M. Y. Chu ◽  
Hextan Y. S. Ngan ◽  
Karen K. L. Chan
Keyword(s):  
Ovarian Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Case Series

scholarly journals Ocular adverse events associated with immune checkpoint inhibitors: a novel multidisciplinary management algorithm

2021 ◽  
Vol 13 ◽  
pp. 175883592199298
Author(s):  
Orthi Shahzad ◽  
Nicola Thompson ◽  
Gerry Clare ◽  
Sarah Welsh ◽  
Erika Damato ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Case Reports ◽  
Case Series ◽  
Simple Algorithm ◽  
Cancer Therapeutics ◽  
Management Algorithm ◽  
Ocular Symptoms ◽  
Systemic Corticosteroids ◽  
Permanent Loss

Ocular immune-related adverse events (IrAEs) associated with use of checkpoint inhibitors (CPIs) in cancer therapeutics are relatively rare, occurring in approximately 1% of treated patients. Recognition and early intervention are essential because the degree of tissue damage may be disproportionate to the symptoms, and lack of appropriate treatment risks permanent loss of vision. International guidelines on managing ocular IrAEs provide limited advice only. Importantly, local interventions can be effective and may avoid the need for systemic corticosteroids, thereby permitting the continuation of CPIs. We present a single institution case series of eight affected patients managed by our multidisciplinary team. Consistent with previously published series and case reports, we identified anterior uveitis as the most common ocular IrAE associated with CPIs requiring intervention. Based on our experience, as well as published guidance, we generated a simple algorithm to assist clinicians efficiently manage patients developing ocular symptoms during treatment with CPIs. In addition, we make recommendations for optimising treatment of uveitis and address implications for ongoing CPI therapy.

scholarly journals POS0645 RITUXIMAB THERAPY IN THE INTERSTITIAL LUNG DISEASE OF RHEUMATOID ARTHRITIS: A SYSTEMATIC REVIEW

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 560.3-561
Author(s):  
E. F. Vicente-Rabaneda ◽  
J. De la Macorra ◽  
J. P. Baldivieso ◽  
F. Gutiérrez-Rodríguez ◽  
A. García-Vadillo ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Interstitial Lung Disease ◽  
Lung Function ◽  
Adverse Events ◽  
Lung Disease ◽  
Statistical Significance ◽  
Connective Tissue Diseases ◽  
Case Series ◽  
Original Research ◽  
Case Control Studies

Background:Interstitial lung disease (ILD) is a severe manifestation of rheumatoid arthritis (RA), linked to increased mortality. There is still no consensus on the best therapeutic strategy as there aren’t yet randomized controlled trials.Objectives:To analyze the available scientific evidence on the efficacy and safety of rituximab (RTX) treatment of interstitial lung disease (ILD) associated with rheumatoid arthritis (RA).Methods:A systematic search was carried out in PubMed until April 2020 following the PRISMA recommendations. Studies were selected according to the following inclusion criteria: (1) original research, including case series, case/control studies, cohort studies, and clinical trials; (2) population with RA and associated ILD, either monographically or together with other connective tissue diseases (CTD), provided that individualized data on patients with RA were provided; (3) patients treated with RTX; (4) objective and quantifiable results on the evolution of ILD after treatment with available data of FVC, DLCO and/or HRCT.Results:Of the 64 papers identified, 9 articles were selected. The studies showed great heterogeneity in design, both in the sample selection criteria and in the objectives of the analysis. Most were observational, retrospective (n = 6) or prospective (n = 2) studies, with only one open prospective experimental study. Those focused on RA predominated, but 3 of them also included patients with other CTDs. The mean age of the patients in the different studies ranged between 52 and 70 years, predominantly women. 40-79% had a history of smoking and were mostly positive for rheumatoid factor (83-100%) and anti-CCP (82-100%). The most frequent radiological patterns were NSIP, UIP and undefined. The outcome measures were diverse: changes in respiratory function tests (LTF) and HRCT, incidence of pulmonary dysfunction, mortality rates, effect on glucocorticoid deprivation, delay in inclusion in the lung transplant list and/or serious adverse events. The initiation of RTX was motivated by pulmonary and/or joint pathology, in patients with failure to other synthetic or biological DMARDs. A total of 393 treatment cycles were collected in 114 patients, with a mean of 3.45 cycles per patient. The RTX regimen was 2 infusions of 1g 2 weeks apart in all patients, except for 1 who received the lymphoma-like regimen. With regard to the efficacy of the treatment with RTX, improvement and especially stabilization of HRCT and LFT predominated, with numerically greater improvement for DLCO than for FVC. There was also a favorable trend in the evolution of patients treated with RTX compared to controls, although it did not reach statistical significance, and a lower risk of deterioration of lung function in patients treated with RTX versus those who had received other DMARDs. The mortality rate found at 5 years was lower than that previously described for the disease and half for the patients treated with RTX compared to those treated with anti-TNF. The adverse events described in the studies did not show additional safety alerts to those already described for RTX.Conclusion:RTX seems to be postulated as a promising therapy for patients with ILD associated with RA, showing a stabilizing effect on the lung function, with an acceptable safety profile. However, further research of higher methodological quality prospective studies is needed to confirm these favorable preliminary results.Disclosure of Interests:None declared

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