Search results for "Adverse Events"

Adverse events as potential predictive factors of activity in patients with advanced hepatocellular carcinoma treated with lenvatinib

2021

Background and Aim: Lenvatinib is a standard of care option in first-line therapy of advanced hepatocellular carcinoma (HCC). In the present study, we aim to identify, in patients with HCC treated with lenvatinib, a possible association between occurrence and grading of adverse events (AEs) and outcome. Methods: We performed a retrospective analysis of 606 Japanese and Italian patients treated with lenvatinib in first-line setting and investigated the possible correlation between the onset of AEs, toxicity grade (G) and outcome measures such as overall survival (OS) and progression-free survival (PFS). Results: The appearance of arterial hypertension G ≥ 2 independently predicted prolonged …

An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

2016

Background: Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods: In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0-F2 fibrosis, patients with HCV-RNA 12-week regimen. Conclusions: Overall SVR12 rate (66%) was below the target of 80%, indicating that sho…

Dermatologic adverse events associated with Juvenile Idiopathic Arthritis treatment

2020

Introduction: Steroids and disease-modifying anti-rheumatic drugs (DMARDs) are widely used in the treatment of juvenile idiopathic arthritis (JIA). Dermatologic adverse events including psoriasis have been reported in treatment of various inflammatory diseases (1-3). However, data regarding the occurrence of dermatologic adverse events in JIA patients are scarce (4-6). Objectives: To determine the prevalence of dermatologic adverse events in JIA patients treated with systemic steroids and DMARDs. To investigate an association between drugs and dermatologic adverse events and the association between anti-TNF treatment and psoriasiform lesions.

Efficacy of a 12-Week Simeprevir Plus Peginterferon/Ribavirin (PR) Regimen in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 4 (GT4) …

2017

Background HCV GT4 accounts for up to 20% of HCV infections worldwide. Simeprevir, given for 12 weeks as part of a 24- or 48-week combination regimen with PR is approved for the treatment of chronic HCV GT4 infection. Primary study objectives were assessment of efficacy and safety of simeprevir plus PR in treatment-naïve patients with HCV GT4 treated for 12 weeks. Primary efficacy outcome was sustained virologic response 12 weeks post-treatment (SVR12). Additional objectives included investigation of potential associations of rapid virologic response and baseline factors with SVR12. Methods This multicentre, open-label, single-arm study (NCT01846832) evaluated efficacy and safety of simepre…

Principal adverse events due to everolimus therapy. A systematic review of the literature

2019

Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

2021

This study evaluates the frequency and causes of dolutegravir (DTG) discontinuation along 5 years of follow-up, in both antiretroviral treatment (ART)-naive and experienced people living with HIV (PLWH). This is a prospective multi-center cohort study enrolling PLWH on DTG from July 2014 until November 2020. DTG-durability was investigated using the Kaplan-Meier survival curve. The Cox proportional-hazards model was used for estimating the hazard ratio (HR) of DTG discontinuation for any cause, and for adverse events (AEs). Nine hundred sixty-three PLWH were included, 25.3% were women and 28.0% were ART-naive. Discontinuations for any causes were 10.1 [95% confidence interval (95% CI) 8.9-1…

Life events and primary monosymptomatic nocturnal enuresis: A pediatric pilot study

2017

Introduction: The association between primary monosymptomatic nocturnal enuresis (PMNE) and behavioral disorders was highlighted frequently, suggesting psychiatric origin. On the other hand, there is no difference between the incidence of mental disorders in children with PMNE and controls, although the psychological genesis could provide additional secondary forms, in which the child might react to stressful events with the resumption of involuntary urination at night, with a possible alteration of bowel control due to a high vulnerability to stressors. The purpose of this study is assessing the stressful events of life in a sample of children with PMNE. Materials and methods: 56 subjects …

Prognostic value of two geriatric screening tools in a cohort of older patients with early stage Non-Small Cell Lung Cancer treated with hypofraction…

2020

Objectives: To investigatewhether assessmentwith two geriatric screening tools shows a correlationwith clinical outcomes of patients aged 65 years or more, with early-stage Non-Small Cell Lung Cancer (es-NSCLC) treated with hypofractionated stereotactic radiotherapy. Methods: FromMarch 2014 to June 2018we retrospectively evaluated 42 patientswith stage I and II lung tumors. Patients were assessed with Charlson Comorbidity Index (CCI) and G8 screening tool. Median age was 74 years (range, 65–91). Stereotactic radiotherapy was performed with Helical Tomotherapy delivering 50–70 Gray (Gy) in 8–10 fractions. Toxicity was evaluated using Common Terminology Criteria for Adverse Events v4.0 criter…

PReS-FINAL-2088: Risk of severe adverse events in juvenile idiopathic arthritis and pediatric-onset inflammatory bowel disease, treated with anti-tnf…

2013

Introduction: Severe adverse events have been described in children affected by Juvenile Idiopathic Arthritis (JIA) and Inflammatory Bowel Disease (IBD) treated with anti-tnf drugs. Objectives: To define the risk of severe adverse events in patients with JIA and IBD treated with anti-tnf drugs. Methods: This is a retrospective cohort study. All patients with JIA and IBD attending the "IRCCS Burlo Garofolo" of Trieste from 2000 to 2012 were enrolled. They were divided into 2 groups on the basis of the presence or absence of anti-tnf exposure. Severe adverse events were considered the followings: a) infections needing anti-tnf permanent suspension and/or hospitalization; b) autoimmune disease…

Cytoreductive surgery and mitomycin C hyperthermic intraperitoneal chemotherapy with CO2 recirculation (HIPEC-CO2) for colorectal cancer peritoneal m…

2021

Peritoneal dissemination from colorectal cancer (CRC) has long been associated with unfavorable prognosis. However, in the last decades, the combination of cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) was able to obtain up to 30% 5-year survival rate in selected centers. Despite the wide diffusion of CRS and HIPEC, until now, there are no clear recommendations on the drug of choice for HIPEC nor its technique, and safety and efficacy data of HIPEC regimens and techniques are lacking. We performed a retrospective analysis of a prospectively maintained database of 26 CRS and mitomycin C HIPEC with CO2 recirculation (HIPEC-CO2) for CRC peritoneal metastasis…