Results 41 to 50 of about 6,007,439 (376)
Adverse Event Burden Score—A Versatile Summary Measure for Cancer Clinical Trials
Cancers, 2020 Simple Summary In cancer clinical trials, adverse event data are collected after every treatment cycle, using the Common Terminology Criteria for adverse events, which includes 837 terms.
J. Le-Rademacher +6 more
semanticscholar +1 more source
Workplace Health & Safety, 2012 Millions of adults are vaccinated annually against the seasonal influenza virus. An undetermined number of individuals will develop adverse events to the influenza vaccination. Those who suffer substantiated vaccine injuries, disabilities, and aggravated conditions may file a timely, no-fault and no-cost petition for financial compensation under the ...
openaire +2 more sources
Spline-based self-controlled case series method [PDF]
, 2017 The self-controlled case series (SCCS) method is an alternative to study designs such as cohort and case control methods and is used to investigate potential associations between the timing of vaccine or other drug exposures and adverse events.
de Boor +15 more
core +1 more source
FDA Adverse Event Reporting System (FAERS) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse Event Data Reported to FAERS. [PDF]
Clin Pharmacol TherThe US Food and Drug Administration (FDA) performs safety assessments throughout the life cycle of a drug. Postmarketing safety surveillance promotes the identification of adverse events not known at the time of approval.
Potter E, Reyes M, Naples J, Dal Pan G.
europepmc +2 more sources
Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation. [PDF]
, 2020 Human cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients, and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit ...
Akard, Luke +22 more
core +3 more sources
Ethics of safety reporting of a clinical trial
Indian Journal of Dermatology, 2017 Clinical trial related injury and serious adverse events (SAE) are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the ...
Amrita Sil, Nilay Kanti Das
doaj +1 more source
Major Outcomes in Atrial Fibrillation Patients with One Risk Factor: Impact of Time in Therapeutic Range [PDF]
, 2016 BACKGROUND: The benefits and harms of oral anticoagulation (OAC) therapy in patients with only one stroke risk factor (i.e. CHA2DS2-VASc= 1 in males, or 2 in females) has been subject of debate.
Lip, Gregory Y. H., Proietti, Marco
core +2 more sources
Tolerability of BRAF/MEK inhibitor combinations: adverse event evaluation and management
ESMO Open, 2019 The inhibition of the mitogen-activated protein kinases signalling pathway through combined use of BRAF and MEK inhibitors (BRAFi+MEKi) represents an established therapeutic option in patients with BRAF-mutated, advanced melanoma.
L. Heinzerling +9 more
semanticscholar +1 more source
Which diagnostic tests are most useful in a chest pain unit protocol? [PDF]
, 2005 Background The chest pain unit (CPU) provides rapid diagnostic assessment for patients with acute, undifferentiated chest pain, using a combination of electrocardiographic (ECG) recording, biochemical markers and provocative cardiac testing.
Angelini, K. +4 more
core +3 more sources
Systematic Reviews, 2021 Background There has been an exponential growth in the number of clinical research studies regarding exercise training in multiple sclerosis, and literature reviews and meta-analyses have documented the many benefits of exercise training.
Y. C. Learmonth +5 more
doaj +1 more source