Search results for " Adverse Events"
showing 10 items of 52 documents
Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational …
2019
Abstract Background Regorafenib prolonged overall survival (OS) versus placebo in patients with treatment-refractory metastatic colorectal cancer (mCRC) in phase III trials. We conducted an observational study of regorafenib for patients with mCRC in real-world clinical practice. Methods The international, prospective, CORRELATE study recruited patients with mCRC previously treated with approved therapies, for whom the decision to treat with regorafenib was made by the treating physician according to the local health authority approved label. The primary objective was safety, assessed by treatment-emergent adverse events (TEAEs; National Cancer Institute Common Terminology Criteria for Adve…
Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohor…
2019
Abstract Background Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 13…
Denosumab for bone health in prostate and breast cancer patients receiving endocrine therapy? A systematic review and a meta-analysis of randomized t…
2019
Highlights • Hormonal receptors positive breast tumor and prostate cancer are managed with endocrine therapies. • Endocrine therapies designed for breast and prostate cancer are often associated to serious adverse skeletal related events, such fractures. • Denosumab is a monoclonal anti-body binding RANKL which acts as inhibitor of osteoclasts activity, thus increasing bone mass. • Denosumab was showed to strongly prevent hormonal therapies-related skeletal issues. • Denosumab administration results safe in bone mass increase and reduction of fractures risk.
Cisplatin and 5-fluorouracil with or without epidermal growth factor receptor inhibition panitumumab for patients with non-resectable, advanced or me…
2020
Background Palliative chemotherapy of advanced oesophageal squamous cell cancer (ESCC) consists of cisplatin/5-fluorouracil (CF) to target epidermal growth factor receptor (EGFR) with panitumumab (P); chemotherapy enhanced overall survival (OS) in advanced colorectal or squamous cell head and neck cancers. With prospective serum and tumour biomarkers, we tested if P added to CF (CFP) improved OS in advanced ESCC. Patients and methods Eligible patients with confirmed ESCC that was not curatively resectable or did not qualify for definitive radiochemotherapy, were randomised 1 : 1 to receive CF [cisplatin (C) 100 mg/m2 i.v., day 1; 5-fluorouracil (F) 1000 mg/m2 i.v., days 1–4] or CF plus P (9…
Safety of red yeast rice supplementation: A systematic review and meta-analysis of randomized controlled trials.
2019
International audience; Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with oth…
Lipase elevation and type 1 diabetes mellitus related to immune checkpoint inhibitor therapy – A multicentre study of 90 patients from the German Der…
2021
Abstract Aim Immune checkpoint inhibition (ICI) triggers immune-related adverse events (irAEs). The relevance of lipase elevation remains unclear. Patients and methods Skin cancer patients with newly detected serum lipase elevation (at least twofold upper normal limit) or newly diagnosed type I diabetes mellitus upon ICI therapy were retrospectively collected at 14 German skin cancer centres. Results We identified 68 patients with lipase elevation occurring after a median time of 19 (range 1–181) weeks on ICI, 15 (22%) thereof had symptoms consistent with pancreatitis. Forty-seven patients (73%) had other irAE, mainly colitis. Discontinuation (n = 24, 35%) or interruption (n = 26, 38%) of I…
Adverse Childhood Experiences Among 28,047 Norwegian Adults From a General Population
2021
Aim: The purpose of this study was to estimate the prevalence of adverse childhood experiences (ACEs) among Norwegian adults from a general population and to identify potential associations with demographic and socioeconomic characteristics.Methods: A randomly drawn sample (N = 61,611) from the public registry of inhabitants was invited to participate in the Norwegian Counties Public Health Survey. The present study was based on online responses from 28,047 adults ≥18 years (mean age: 46.9 years, SD = 16.03). Log-link binomial regression analyses were performed to examine associations between four measures of ACEs (family conflict, lack of adult support, bad memories, and difficult childhoo…
The Prevalence and Consequences of Adverse Childhood Experiences in the German Population
2019
Background Multiple studies have shown a link between cumulative adverse experiences in childhood and a wide variety of psychosocial problems in later life. There have not been any pertinent representative studies of the German population until now. The goal of this study is to determine the frequency of adverse childhood experiences (ACE), the extent to which they manifest themselves in patterns of co-occurrence, and their possible connection to psychosocial abnormalities in the German population. Methods 2531 persons (55.4% female) aged 14 years and up (mean [M] = 48.6 years, standard deviation [SD] = 18) were retro- spectively studied for ACE and psychosocial abnormalities by means of th…
Childhood Victimization by Adults and Peers and Health-Risk Behaviors in Adulthood
2019
AbstractVictimization experienced in childhood has been linked with health-risk behaviors (HRBs) in adulthood. The purpose of this cross-sectional survey was to provide data regarding the HRBs using the ISPCAN Child Abuse Screening Tool Retrospective version (ICAST-R), Spanish version. This aimed to broaden existing knowledge by assessing both being victimized by adults and by peers in a Spanish general population of 348, aged 18–35. Age and timing of the reported victimization were also considered. Victimization: physical, psychological, sexual abuse by adults and/or peers showed a prevalence of 44.54%. Of these, 41.29% reported abuse by both. Children victimized by adults, regardless of t…
Second Malignancies Following Childhood Cancer Treatment in Germany From 1980 to 2014.
2018
BACKGROUND Because of improvements in cancer treatment, more than 80% of all children with cancer now survive at least five years from the time of diagnosis. As a result, late sequelae of cancer and its treatment have become more common, particularly second malignancies. We studied the current incidence of second malignancies among childhood cancer survivors in Germany. METHODS This study is based on the cohort of the German Childhood Cancer Registry (Deutsches Kinderkrebsregister, DKKR). Persons given the diagnosis of a first malignancy at any time in the years 1980-2014 who were no more than 14 years old at the time of diagnosis and survived at least six months thereafter were included in…