Search results for "Drug-related side effects and adverse reaction"
showing 10 items of 98 documents
What can visual caregivers expect with patients treated for SARS-CoV-2? An analysis of ongoing clinical trials and ocular side effects
2020
Within the COVID-19 pandemic context, the WHO has proposed a list of medicines to treat patients with severe acute respiratory syndrome (SARS-CoV-2). An analysis of their ocular side effects was performed. Only chloroquine and hydroxychloroquine were found to have an ocular impact in the medium and long-term. Detailed search strategies were performed in EMBASE, MEDLINE, SCOPUS and WOS Core Collection. Additionally, the worldwide ongoing clinical trials including chloroquine or hydroxychloroquine were evaluated, and their proposals of drug administration and exclusion criteria analyzed. In general, high maximum cumulative doses of chloroquine or hydroxychloroquine are being used for a short…
Towards identifying drug side effects from social media using active learning and crowd sourcing.
2019
Motivation Social media is a largely untapped source of information on side effects of drugs. Twitter in particular is widely used to report on everyday events and personal ailments. However, labeling this noisy data is a difficult problem because labeled training data is sparse and automatic labeling is error-prone. Crowd sourcing can help in such a scenario to obtain more reliable labels, but is expensive in comparison because workers have to be paid. To remedy this, semi-supervised active learning may reduce the number of labeled data needed and focus the manual labeling process on important information. Results We extracted data from Twitter using the public API. We subsequently use Ama…
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Canc…
2018
AbstractPurpose: This single-arm, open-label phase II study evaluated the safety and efficacy of taselisib (GDC-0032) plus fulvestrant in postmenopausal women with locally advanced or metastatic HER2-negative, hormone receptor (HR)-positive breast cancer.Patients and Methods: Patients received 6-mg oral taselisib capsules daily plus intramuscular fulvestrant (500 mg) until disease progression or unacceptable toxicity. Tumor tissue (if available) was centrally evaluated for PIK3CA mutations. Adverse events (AE) were recorded using NCI-CTCAE v4.0. Tumor response was investigator-determined using RECIST v1.1.Results: Median treatment duration was 4.6 (range: 0.9–40.5) months. All patients expe…
Medication safety in a psychiatric hospital
2007
Objective: We sought to assess the epidemiology of medication errors (MEs) and adverse drug events (ADEs) in a psychiatric hospital. Methods: We conducted a 6-month prospective observational study in a 172-bed academic psychiatric hospital. Errors and ADEs were found by way of chart review, staff reports and pharmacy intervention reports. Physicians rated incidents as to the presence of injury, preventability and severity of an injury. Serious MEs were nonintercepted MEs with potential for harm (near misses) and preventable ADEs. Results: We studied 1871 admissions with 19,180 patient-days. The rate of ADEs and serious MEs were 10 and 6.3 per 1000 patient-days, respectively. Preventable ADE…
Gastrointestinal disturbances and their management in miglustat‐treated patients
2011
Miglustat (Zavesca®) is approved for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease (GD1) for whom enzyme replacement therapy is unsuitable, and for the treatment of progressive neurological manifestations in adult and paediatric patients with Niemann-Pick disease type C (NP-C). Gastrointestinal disturbances such as diarrhoea, flatulence and abdominal pain/discomfort have consistently been reported as the most frequent adverse events associated with miglustat during clinical trials and in real-world clinical practice settings. These adverse events are generally mild or moderate in severity, occurring mostly during the initial weeks of therapy. The mechanis…
How we prevent and treat differentiation syndrome in patients with acute promyelocytic leukemia
2014
Abstract Differentiation syndrome (DS), formerly known as retinoic acid syndrome, is a relatively common and potentially severe complication seen in patients with acute promyelocytic leukemia treated with all-trans retinoic acid and/or arsenic trioxide. The full-blown syndrome consists of unexplained fever, weight gain, dyspnea with pulmonary infiltrates, pleuropericardial effusion, hypotension, and renal failure. Most measures currently used for management of DS have very little evidence-based support, and therefore, many remain controversial. Despite the lack of evidence supporting DS prophylaxis, several groups have adopted a preventive strategy with corticosteroids, especially for patie…
Clinical evaluation of drug-induced hepatitis
2005
Objective: to ascertain the epidemiological characteristics, clinical symptoms, and evolution of drug-induced hepatitis over the last 22 years. Experimental design and subjects: an observational, retrospective study between 1982 and 1993, and prospective study between 1994 and 2003. All patients in our department diagnosed with having drug-induced hepatitis were studied analyzing epidemiological (age, sex, cases per year, hospitalization) and clinical features (previous liver disease, hepatic symptoms, laboratory results), and follow-up (complete recovery or chronicity). Results: a total of 61 patients were diagnosed as having drug-induced hepatitis, 26 men and 35 women (57%), mean age 52.4…
Efficacy and tolerability of lasmiditan, an oral 5-HT1F receptor agonist, for the acute treatment of migraine : a phase 2 randomised, placebo-control…
2012
Lasmiditan (COL-144) is a novel, centrally acting, highly selective 5-HT(1F) receptor agonist without vasoconstrictor activity that seemed effective when given as an intravenous infusion in a proof-of-concept migraine study. We aimed to assess the efficacy and safety of oral lasmiditan for the acute treatment of migraine.In this multicentre, double-blind, parallel-group, dose-ranging study in 43 headache centres in five European countries, patients with migraine with and without aura and who were not using prophylaxis were randomly assigned (1:1:1:1:1) to treat one moderate or severe attack at home with 50 mg, 100 mg, 200 mg, or 400 mg lasmiditan, or placebo. Study drug and placebo were sup…
Intravenous injection of bortezomib, melphalan and dexamethasone in refractory and relapsed multiple myeloma
2013
Abstract Background A combination of bortezomib (1.3 mg/m2), melphalan (5 mg/m2), and dexamethasone (40 mg) (BMD), with all three drugs given as a contemporary intravenous administration, was retrospectively evaluated. Patients and methods Fifty previously treated (median 2 previous lines) patients with myeloma (33 relapsed and 17 refractory) were assessed. The first 19 patients were treated with a twice-a-week (days 1, 4, 8, 11, ‘base’ schedule) administration while, in the remaining 31 patients, the three drugs were administered once a week (days 1, 8, 15, 22, ‘weekly’ schedule). Results Side-effects were predictable and manageable, with prominent haematological toxicity, and a better tox…
Caspofungin for the treatment of candidaemia in patients with haematological malignancies
2010
AbstractThis study was prospectively conducted in 11 haematology divisions over a 2-year period to evaluate the efficacy of caspofungin in 24 neutropenic patients with haematological malignancies (HM) and candidaemia. These patients had received chemotherapy for HM and were neutropenic (PNN < 0.5 × 109/L) for a median of 12 days (2–41) before candidaemia. The patients received caspofungin for a median duration of 12 days (range 6–26), obtaining a favourable overall response of 58%. At 30 days, 11 patients had died (46%); candidaemia was responsible for mortality in six patients (25%). These results suggest that treatment of candidaemia with caspofungin in neutropenic HM was efficacious, as …