Toxic Epidermal Necrolysis During Dronedarone Treatment: First Report of a Severe Serious Adverse Event Of A New Antiarrhythmic Drug

2015 ◽  
Vol 15 (4) ◽  
pp. 399-401 ◽  
Author(s):  
Thomas Gecks ◽  
Dirk Prochnau ◽  
Marcus Franz ◽  
Christian Jung ◽  
Helmut Kühnert ◽  
...  
Keyword(s):  
Adverse Event ◽  
Toxic Epidermal Necrolysis ◽  
Antiarrhythmic Drug ◽  
Serious Adverse Event ◽  
First Report

scholarly journals Interim Estimates of COVID-19 Vaccine Effectiveness in a Mass Vaccination Setting: Data from an Italian Province

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 628
Author(s):  
Maria Elena Flacco ◽  
Graziella Soldato ◽  
Cecilia Acuti Martellucci ◽  
Roberto Carota ◽  
Rossano Di Luzio ◽  
...  
Keyword(s):  
Adverse Event ◽  
Retrospective Cohort ◽  
Cox Model ◽  
National Health System ◽  
Vaccine Dose ◽  
Vaccine Hesitancy ◽  
Serious Adverse Event ◽  
Italian Province ◽  
Official Data

This retrospective cohort study compared the rates of virologically-confirmed SARS-CoV-2 infections, symptomatic or lethal COVID-19 among the residents of the Italian province of Pescara who received one or two doses of COVID-19 vaccines, versus the unvaccinated. The official data of the National Health System were used, and a total of 69,539 vaccinated adults were compared with 175,687 unvaccinated. Among the subjects who received at least one vaccine dose, 85 infections (0.12%), 18 severe and 3 lethal COVID-19 cases were recorded after an average follow-up of 38 days. Among the unvaccinated, the numbers were 6948 (4.00%), 933 (0.53%) and 241 (0.14%), respectively. The serious adverse event reports—yet unconfirmed—were 24 out of 102,394 administered doses. In a Cox model, adjusting for age, gender, and selected comorbidities, the effectiveness of either BNT162b2, ChAdOx1 nCoV-19 or mRNA-1273 vaccines was higher than 95% in preventing infections (mostly due to B.1.1.7 variant), symptomatic or lethal COVID-19. No differences were observed across genders, and among the 691 subjects who received the second dose of vaccine later than the recommended date. Although preliminary, these findings support current immunization policies and may help reducing vaccine hesitancy.

Myocarditis as a rare, yet serious adverse event associated with immune checkpoint inhibitors in patients with non-small cell lung cancer: Case series from a large community-based cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21047-e21047
Author(s):  
Mohamed Hendawi ◽  
Luke Peterson ◽  
Eyob ale Tadesse ◽  
Frank M. Wolf ◽  
Thomas D. Brown ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Event ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Small Cell ◽  
Small Cell Lung ◽  
Serious Adverse Event

e21047 Background: Patients (pts) with lung cancer and other cancers treated with immune checkpoint inhibitors (ICI) may experience immune related adverse events (irAE). These can present with variable severity and with single- or multi-organ involvement including pneumonitis, colitis, hepatitis, and myocarditis/pericarditis. The incidence of myocarditis has been reported between 0.06% and 2.4% and is associated with a high mortality (25% to 50%). This retrospective review of real-world data (RWD) investigates myocarditis as a high-grade adverse event in pts with lung cancer treated with ICIs. Methods: Pts were identified and characterized using RWD in the Syapse Learning Health Network platform from 2010 to 2020 at Advocate Aurora Health Care. Eligible pts included: ≥18 years old; histologically confirmed NSCLC; and myocarditis diagnosis by ICD codes. Additional chart review was performed to confirm timing of ICI treatment and myocarditis. All pts identification and review were performed after IRB review. Results: 12,686 pts with non-small cell lung cancer were eligible for review. The median age at diagnosis was 70; 54% were female; 86% were White and 12% were Black; 1,975 (15.6%) were treated with an ICI and of those 4 cases (0.2%) of myocarditis were identified. All 4 pts were White females, ages 46, 59, 65, and 74 years. Pathology included lung adenocarcinoma (3) and an undifferentiated lung carcinoma (1). All pts had metastatic disease, and none had a prior history of cardiac disease. ICIs were pembrolizumab (2), durvalumab (1), and nivolumab (1). Median time from initial dose of ICI to diagnosis of myocarditis was 62 days [range: 42-185]. All 4 pts presented with chest pain and elevated troponin T [median 0.07 ng/ml (range: 0.06-0.08)]. All pts had echocardiography at the time of diagnosis, and 2 pts had cardiac MRI that confirmed myocarditis. 3 pts were treated with a prednisone taper. 1 pt died of recurrent congestive heart failure and ventricular tachycardia despite rescue attempt with high dose corticosteroids. 2 pts had additional concomitant irAEs of hypothyroidism/colitis, and thyroiditis/pneumonitis, respectively. Conclusions: Many irAEs are reversible. This RWD analysis confirms that clinically evident myocarditis is a rare but serious adverse event of ICI therapy. Early consideration, diagnosis, and intervention may help prevent poor outcomes. Termination of ICI therapy along with initiation of corticosteroids constitute the current standard of management. Further research is warranted to better identify high risk groups, surveillance measures, and improved management of ICI associated myocarditis.

scholarly journals Pneumonitis from immune checkpoint inhibitors and COVID-19: current concern in cancer treatment

2020 ◽  
Vol 8 (2) ◽  
pp. e000952 ◽  
Author(s):  
Ernesto Rossi ◽  
Giovanni Schinzari ◽  
Giampaolo Tortora
Keyword(s):  
Adverse Event ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Clinical Symptoms ◽  
Checkpoint Inhibitors ◽  
Radiological Findings ◽  
Serious Adverse Event ◽  
Appropriate Treatment ◽  
Current Concern ◽  
Coronavirus Infection

Pneumonitis is a rare but serious adverse event caused by cancer immunotherapy. The diagnosis between COVID-19-induced pneumonia and immunotherapy-induced pneumonitis may be challenging in the era of COVID-19 outbreak. Some clinical symptoms and radiological findings of pneumonitis can be attributed to the coronavirus infection as well as to an immune-related adverse event. Identifying the exact cause of a pneumonitis in patients on treatment with immunotherapy is crucial to promptly start the most appropriate treatment. The proper management of immune checkpoint inhibitors for the risk of pneumonia must take into account a series of parameters. Accurate attention should be payed to symptoms like cough, fever and dyspnea during immunotherapy.

scholarly journals A previously unreported serious adverse event during balloon sinuplasty

2013 ◽  
Vol 2013 (jan28 1) ◽  
pp. bcr2012007879-bcr2012007879 ◽  
Author(s):  
N. Hughes ◽  
J. Bewick ◽  
R. Van Der Most ◽  
M. O'Connell
Keyword(s):  
Adverse Event ◽  
Serious Adverse Event ◽  
Balloon Sinuplasty

scholarly journals Analysis of loss to follow-up in 4099 multidrug-resistant pulmonary tuberculosis patients

2019 ◽  
Vol 54 (1) ◽  
pp. 1800353 ◽  
Author(s):  
Ian F. Walker ◽  
Oumin Shi ◽  
Joseph P. Hicks ◽  
Helen Elsey ◽  
Xiaolin Wei ◽  
...  
Keyword(s):  
Risk Factors ◽  
Adverse Event ◽  
Treatment Success ◽  
Multidrug Resistant ◽  
Cox Proportional Hazards Model ◽  
Serious Adverse Event ◽  
Loss To Follow Up ◽  
Factors Associated ◽  
Mdr Tb

Loss to follow-up (LFU) of ≥2 consecutive months contributes to the poor levels of treatment success in multidrug-resistant tuberculosis (MDR-TB) reported by TB programmes. We explored the timing of when LFU occurs by month of MDR-TB treatment and identified patient-level risk factors associated with LFU.We analysed a dataset of individual MDR-TB patient data (4099 patients from 22 countries). We used Kaplan–Meier survival curves to plot time to LFU and a Cox proportional hazards model to explore the association of potential risk factors with LFU.Around one-sixth (n=702) of patients were recorded as LFU. Median (interquartile range) time to LFU was 7 (3–11) months. The majority of LFU occurred in the initial phase of treatment (75% in the first 11 months). Major risk factors associated with LFU were: age 36–50 years (HR 1.3, 95% CI 1.0–1.6; p=0.04) compared with age 0–25 years, being HIV positive (HR 1.8, 95% CI 1.2–2.7; p<0.01) compared with HIV negative, on an individualised treatment regimen (HR 0.7, 95% CI 0.6–1.0; p=0.03) compared with a standardised regimen and a recorded serious adverse event (HR 0.5, 95% CI 0.4–0.6; p<0.01) compared with no serious adverse event.Both patient- and regimen-related factors were associated with LFU, which may guide interventions to improve treatment adherence, particularly in the first 11 months.

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