Search results for " adverse reactions"
showing 10 items of 100 documents
Safety of meglumine gadoterate (Gd-DOTA)-enhanced MRI compared to unenhanced MRI in patients with chronic kidney disease (RESCUE study).
2012
To prospectively compare the renal safety of meglumine gadoterate (Gd-DOTA)-enhanced magnetic resonance imaging (MRI) to a control group (unenhanced MRI) in high-risk patients.Patients with chronic kidney disease (CKD) scheduled for MRI procedures were screened. The primary endpoint was the percentage of patients with an elevation of serum creatinine levels, measured 72 ± 24 h after the MRI procedure, by at least 25 % or 44.2 μmol/l (0.5 mg/dl) from baseline. A non-inferiority margin of the between-group difference was set at -15 % for statistical analysis of the primary endpoint. Main secondary endpoints were the variation in serum creatinine and eGFR values between baseline and 72 ± 24 h …
Outcomes of Patients Hospitalized with Community-Acquired, Health Care-Associated, and Hospital-Acquired Pneumonia
2009
Background Traditionally, pneumonia has been classified as either community- or hospital-acquired. Although only limited data are available, health care-associated pneumonia has been recently proposed as a new category of respiratory infection. "Health care-associated pneumonia" refers to pneumonia in patients who have recently been hospitalized, had hemodialysis, or received intravenous chemotherapy or reside in a nursing home or long-term care facility. Objective To ascertain the epidemiology and outcome of community-acquired, health care-associated, and hospital-acquired pneumonia in adults hospitalized in internal medicine wards. Design Multicenter, prospective observational study. Sett…
Lack of effect of azithromycin on QT interval in children: a cohort study.
2016
Macrolides are a group of antimicrobial drugs used widely, being well known for their adverse cardiac effects. Erythromycin and clarithromycin are most commonly associated with these conditions. In recent years, azithromycin (AZM) has been assessed because of its possible relation to arrhythmias (mainly QT interval prolongation) and risk of cardiovascular death.1 The pharmacodynamics of these effects is complex and the occurrence of cardiovascular death is unpredictable.2 However, all published manuscripts on the cardiac effects of AZM to date are cases in adults or …
Adverse drug reactions in children reported by means of the yellow card in Spain.
2000
Abstract Objective: To analyze the case reports concerning children (14 years or younger) in the Spanish Pharmacovigilance System over a 10-year period (1982–1991). Findings: The study of 1419 reports of adverse drug reaction (9.8% of all those received) showed the most commonly involved organs and systems to be the skin, digestive tract, and nervous system (62.8%). The most commonly involved pharmacological groups were antibiotics, respiratory medications, and vaccines (69%). The absolute number of reports is higher in children between 1 and 4 years of age (37.9%). There were more reports among males than in females. Less than 5% of the reports notified directly life-threatening or fatal r…
Adverse effects of heavy cannabis use: even plants can harm the brain.
2020
The spread of laws legalising cannabis for medicinal or recreational use has been accompanied by more relaxed attitudes towards cannabis. Data from the United States show that in states that have legalised cannabis, prevalence of daily, weekly, and monthly cannabis use was 11.3%, 18.3%, and 25.0% respectively, whereas in countries where it is still illegal, it was lower (7.4%, 11.6%, and 16.8% respectively). Evidence indicates a trend of increase among adolescents, a particular vulnerable category for the initiation of substance use. In parallel, we have seen the concentration of THC (D-9-tetrahydrocannabinol) in the cannabis sold both in the United States and in Europe rising and those typ…
Safety and Pharmacokinetics/Pharmacodynamics of the First-in-Class Dual Action HER3/EGFR Antibody MEHD7945A in Locally Advanced or Metastatic Epithel…
2015
Abstract Purpose: The novel dual-action humanized IgG1 antibody MEHD7945A targeting HER3 and EGFR inhibits ligand-dependent HER dimer signaling. This phase I study evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of MEHD7945A. Experimental Design: Patients with locally advanced or metastatic epithelial tumors received escalating doses of MEHD7945A (1–30 mg/kg) every 2 weeks (q2w) until disease progression or intolerable toxicity. An expansion cohort was enrolled at the recommended phase II dose (14 mg/kg, q2w). Plasma samples, tumor biopsies, FDG-PET were obtained for assessment of pharmacokinetics, and pharmacodynamic modulation downstream of EGFR and HER3. …
Safety and activity of trastuzumab-containing therapies for the treatment of metastatic breast cancer: our long-term clinical experience (GOIM study).
2007
Background: Trastuzumab is widely used as the treatment of choice for HER2-positive metastatic breast cancer (MBC). Patients and methods: Seventy patients, median age 57 years and range 31-81 years, were included in our retrospective analysis with the aim to evaluate safety and activity of trastuzumab-containing therapies. Results: We observed for first-line treatment response rate (RR) 41%, stable disease (SD) 47% and time to progression (TTP) 8 months (range 1-44). Corresponding numbers for second line were RR 23%, SD 62% and (TTP) 9 months (range 3-23) and beyond second line RR 22%, SD 78% and (TTP) 9 months (range 4-19). Overall survival was 19.2 months (3-62 months). The median cumulat…
Efficacy and safety of irinotecan-based chemotherapy for advanced colorectal cancer outside clinical trials: an observational study.
2010
Background: This prospective observational study in typical community-based outpatient clinics evaluated the efficacy and toxicity of weekly and biweekly irinotecan-based chemotherapies and their compatibility depending on age. Methods: 601 patients with advanced or metastatic colorectal cancer receiving first-, second-, or third-line irinotecanbased therapy were regularly analyzed for response and toxicity until the end of therapy. Results: The median age was 65 (28–87) years, approximately one-third of the patients were ≥70 years old. Of all patients, 405 were treated weekly and 68 biweekly. Median overall survival (OS) for first-line therapy was 26.5 months for the <70-year-old patients …
Comparative assessment of docetaxel for safety and efficacy between hormone-sensitive and castration-resistant metastatic prostate cancer.
2019
To compare toxicity and response of docetaxel chemotherapy between metastatic hormone-sensitive prostate cancer (mHSPC) and castration-resistant metastatic prostate cancer (mCRPC) patients of the same therapeutic era for assessing of upfront docetaxel against the benchmark of docetaxel in the castrate resistant stage in the setting outside of clinical trials.A prospectively collected database of real-world prostate cancer patients receiving docetaxel was divided in mHSPC and mCRPC cases and retrospectively analyzed. Principal objectives were toxicity measured by the common criteria of adverse events terminology and response characterized by Prostate specific antigen decline and radiographic…
Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study.
2016
Abstract Purpose: Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months. Experimental Design: The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014. Results: Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor s…