Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms
Keywords: MedDRA; SNOMED-CT; Ontology; Terminology; Semantic reasoning; Adverse drug reaction;
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Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: A randomized, 28-day, dose-ranging trial
Keywords: HCV; hepatitis C virus; PegIFN; pegylated interferon; RBV; ribavirin; RVR; rapid virologic response; SVR; sustained virologic response; IL; interleukin; LOD; limit of detection; MedDRA; Medical Dictionary for Regulatory Activities; ECG; electrocardiogram;
Research ArticleA phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1
Keywords: HCV; hepatitis C virus; CYP3A4; cytochrome P450 isoform 3A4; RNA; ribonucleic acid; IL28B; interleukin-28B; LiPA; Versant® HCV Genotype Inno-LiPA Assay, version 2.0; MedDRA; Medical Dictionary for Regulatory Activities; OATP1B1; organic anion transportin
Analysis of Upper Gastrointestinal Adverse Events Among Patients Given Dabigatran in the RE-LY Trial
Keywords: Upset Stomach; Clinical Trial; Post Hoc Analysis; Side Effect; Toxicity; AE; adverse event; CI; confidence interval; FDA; Food and Drug Administration; GERD; gastroesophageal reflux disease; GI; gastrointestinal; H2RA; histamine-2 receptor-antagonist; Med
A pre-marketing ALT signal predicts post-marketing liver safety
Keywords: DILI; drug induced liver injury; FDA; Food and Drug Administration; AERS; Adverse Event Reporting System; ALT; alanine aminotransferase; ULN; upper limit of normal; NDA; new drug application; EMA; European Medicines Agency; PDR; Physician's Desk Referen
Real-life versus package insert: A post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers
Keywords: AE; adverse events; AEFI; adverse events following immunization; HAV; hepatitis A virus; SPC; summary of product characteristics; SOC; system organ classes; MedDRA; medical dictionary for regulatory activities; Safety; Self-reporting; Virosomal vaccine; H
Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life
Keywords: AE; adverse event; ATP; according-to-protocol; CCID; Cell Culture Infective Dose; CI; confidence interval; DTPa; diphtheria-tetanus-acellular pertussis; ELISA; Enzyme-Linked Immunosorbent Assay; GMC; geometric mean concentration; GSK; GlaxoSmithKline; HBV
A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults
Keywords: AE; adverse event; CI; confidence interval; FFU; fluorescent focus units; GMFR; geometric mean fold rise from baseline; GMT; geometric mean titer; HAI; hemagglutination inhibition; MedDRA; Medical Dictionary for Regulatory Activities; Q/LAIV; quadrivalent
Immunological priming induced by a two-dose series of H5N1 influenza antigen, administered alone or in combination with two different formulations of AS03 adjuvant in adults: Results of a randomised single heterologous booster dose study at 15 months
Keywords: AE; adverse event; ANCOVA; analysis of covariance; AS03; oil-in-water emulsion based Adjuvant System containing tocopherol; ATP; according to protocol; CBER; Center for Biologics Evaluation and Research; CI; confidence interval; FDA; Food and Drug Adminis
Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs
Keywords: Electronic data capture; Electronic case report form; Post-marketing study; CDASH; MedDRA; Pharmacovigilance; UADEADR, Adverse drug reaction; CDASH, Clinical Data Acquisition Standards Harmonization; CDISC, Clinical Data Interchange Standards Consortium;
A Lung Biopsy Tract Plug for Reduction of Postbiopsy Pneumothorax and Other Complications: Results of a Prospective, Multicenter, Randomized, Controlled Clinical Study
Keywords: PA; posteroanterior; ABCS; autologous blood clot seal; MedDRA; Medical Dictionary for Regulatory Activities;
Prediction of drug-related cardiac adverse effects in humans—A: Creation of a database of effects and identification of factors affecting their occurrence
Keywords: AERS; BioEpisteme™; Clinical indication; Drug-induced cardiac toxicity; Drug-related adverse effect; In silico; Mechanism of action; MedDRA; QSAR; Quantitative structure–activity relationships; SRS; Therapeutic target
Influence of the MedDRA® hierarchy on pharmacovigilance data mining results
Keywords: MedDRA; Data mining; Terminology; Proportional reporting rate; Urn model; Gamma Poisson Shrinker
Analysis of behavior-related adverse experiences in clinical trials of montelukast
Keywords: Montelukast; placebo; clinical trial; behavior; psychiatric; adverse experiences; asthma; allergic rhinitis; AE; Adverse experience; Akath-PT; Akathisia-related preferred term; BRAE; Behavior-related adverse experience; CNS; Central nervous system; CysLT1
About the necessity to manage events coded with MedDRA prior to statistical analysis: Proposal of a strategy with application to a randomized clinical trial, ANRS 099 ALIZE ★
Keywords: MedDRA; Event retrieval; Safety report
Serious Adverse Events With Infliximab: Analysis of Spontaneously Reported Adverse Events
Keywords: AERS; adverse event reporting system; CI; confidence interval; EBGM; empiric Bayes geometric mean; EB05; empiric Bayes lower 90% confidence bound; EB95; empiric Bayes upper 90% confidence bound; FDA; U.S. Food and Drug Administration; MedDRA; Medical Dict
Safety and Tolerability of Tegaserod in Patients With Chronic Constipation: Pooled Data From Two Phase III Studies
Keywords: AEs; adverse events; CC; chronic constipation; CK; creatine kinase; CSBM; complete spontaneous bowel movement; ECG; electrocardiogram; GI; gastrointestinal; 5-HT; 5-hydroxytryptamine; IBS-C; irritable bowel syndrome with constipation; MedDRA; Medical Dict
Experience using MedDRA for global events coding in HIV clinical trials
Keywords: MedDRA; Adverse events; Lowest level term; Preferred term; Clinical trials
Tacrolimus ointment is more effective than pimecrolimus cream with a similar safety profile in the treatment of atopic dermatitis: Results from 3 randomized, comparative studies
Keywords: AD; atopic dermatitis; BSA; body surface area; %BSA; percentage of total body surface area; EASI; Eczema Area and Severity Index; EOS; end of study; IGADA; Investigator's Global Atopic Dermatitis Assessment; MedDRA; Medical Dictionary for Regulatory Activ