Adverse Drug Reaction Reporting Systems
-
Subject Areas on Research
-
A 12-week, randomized, double-blind, placebo-controlled study evaluating the effect of eszopiclone 2 mg on sleep/wake function in older adults with primary and comorbid insomnia.
-
A Review of Methods for Monitoring Adverse Events in Pediatric Psychopharmacology Clinical Trials.
-
A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus.
-
Adverse drug events caused by serious medication administration errors.
-
Adverse event load, onset, and maximum grade: A novel method of reporting adverse events in cancer clinical trials.
-
Age-related differences in reporting of drug-associated liver injury: data-mining of WHO Safety Report Database.
-
All-Cause Mortality and Cardiovascular Outcomes With Non-Vitamin K Oral Anticoagulants Versus Warfarin in Patients With Heart Failure in the Food and Drug Administration Adverse Event Reporting System.
-
Application of FDA adverse event report data to the surveillance of dietary botanical supplements.
-
Association between pathologic gambling and parkinsonian therapy as detected in the Food and Drug Administration Adverse Event database.
-
Atypical antipsychotic drugs and diabetes mellitus in the US Food and Drug Administration Adverse Event database: a systematic Bayesian signal detection analysis.
-
Atypical antipsychotics and pituitary neoplasms in the WHO database.
-
Atypical antipsychotics and pituitary tumors: a pharmacovigilance study.
-
Automated support for pharmacovigilance: a proposed system.
-
Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST).
-
Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.
-
Case reports of heart failure after therapy with a tumor necrosis factor antagonist.
-
Cholinesterase inhibitors and Pisa syndrome: a pharmacovigilance study.
-
Clopidogrel-associated TTP: an update of pharmacovigilance efforts conducted by independent researchers, pharmaceutical suppliers, and the Food and Drug Administration.
-
Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
-
Comedications alter drug-induced liver injury reporting frequency: Data mining in the WHO VigiBase™.
-
Comparing data mining methods on the VAERS database.
-
Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
-
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology.
-
Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
-
Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events.
-
Culture counts--sustainable inpatient computerized surveillance across Duke University Health System.
-
Design, implementation and evaluation of a clinical decision support system to prevent adverse drug events.
-
Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).
-
Do geriatric conditions increase risk of adverse drug reactions in ambulatory elders? Results from the VA GEM Drug Study.
-
Drug induced hepatotoxicity: data from the Serbian pharmacovigilance database.
-
Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work.
-
Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative.
-
Evaluation of different recall periods for the US National Cancer Institute's PRO-CTCAE.
-
Final conclusions and recommendations of the National Lipid Association Statin Safety Assessment Task Force.
-
Glucose homeostasis abnormalities associated with use of gatifloxacin.
-
Identifying genomic and developmental causes of adverse drug reactions in children.
-
Idiosyncratic Drug Induced Liver Injury in African-Americans Is Associated With Greater Morbidity and Mortality Compared to Caucasians.
-
Impediments to clinical research in the United States.
-
Incidence and predictors of all and preventable adverse drug reactions in frail elderly persons after hospital stay.
-
Interplay of gender, age and drug properties on reporting frequency of drug-induced liver injury.
-
Invasive and in situ cervical cancer reported to the vaccine adverse event reporting system (VAERS).
-
Knowledge, Perceptions, and Attitudes Regarding Antibiotic Use for Lower Respiratory Tract Infections: Insights from Patients in Sri Lanka.
-
Mapping child and adolescent self-reported symptom data to clinician-reported adverse event grading to improve pediatric oncology care and research.
-
Medication errors in acute cardiac care: An American Heart Association scientific statement from the Council on Clinical Cardiology Subcommittee on Acute Cardiac Care, Council on Cardiopulmonary and Critical Care, Council on Cardiovascular Nursing, and Council on Stroke.
-
Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).
-
Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs.
-
Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
-
National Survey of Neonatal Intensive Care Unit Medication Safety Practices.
-
Navigating parental vaccine hesitancy.
-
Neuropsychiatric adverse effects of oseltamivir in the FDA Adverse Event Reporting System, 1999-2012.
-
Non-reassuring fetal status: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.
-
Nonsteroidal antiinflammatory drug toxicity monitoring and safety practices.
-
Novel method to collect medication adverse events in juvenile arthritis: results from the childhood arthritis and rheumatology research alliance enhanced drug safety surveillance project.
-
Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.
-
Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience.
-
Pancreatitis associated with atypical antipsychotics: from the Food and Drug Administration's MedWatch surveillance system and published reports.
-
Paroxetine: safety and tolerability issues.
-
Pediatric post-marketing safety systems in North America: assessment of the current status.
-
Pharmacovigilance and safety aspects of sevoflurane.
-
Pharmacovigilance in the 21st century: new systematic tools for an old problem.
-
Population-based drug-related anaphylaxis in children and adolescents captured by South Carolina Emergency Room Hospital Discharge Database (SCERHDD) (2000-2002).
-
Premature release of data from clinical trials of ezetimibe.
-
Reevaluating the safety profile of pediatrics: a comparison of computerized adverse drug event surveillance and voluntary reporting in the pediatric environment.
-
Risperidone-associated diabetes mellitus: a pharmacovigilance study.
-
Safety monitoring of drugs receiving pediatric marketing exclusivity.
-
Screening for Adverse Drug Reactions in Dementia Patients on Cholinesterase Inhibitor Therapy.
-
Statistical methods for exploring spontaneous adverse event reporting databases for drug-host factor interactions.
-
The FDA Sentinel Initiative - An Evolving National Resource.
-
The first step to integrating the child's voice in adverse event reporting in oncology trials: a content validation study among pediatric oncology clinicians.
-
Ticlopidine- and clopidogrel-associated thrombotic thrombocytopenic purpura (TTP): review of clinical, laboratory, epidemiological, and pharmacovigilance findings (1989-2008).
-
Torsades de pointes associated with fluoroquinolones.
-
Two mechanistic pathways for thienopyridine-associated thrombotic thrombocytopenic purpura: a report from the SERF-TTP Research Group and the RADAR Project.
-
Validity and Reliability of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.
-
Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).