Adverse event reporting: A brief overview of MedDRA

Morley, Gregory

doi:10.1179/2047480614z.000000000208

Cited by 4 publications

(2 citation statements)

References 7 publications

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“…The MedDRA is a medical dictionary that contains five levels ranging from very general (the System Organ Class level) to very specific terms (the Lowest Level Term level). The fourth, preferred term (PT) level was used for the ADR assessment which is the level most often used in safety reporting for analysis . The use of the PT level implies that a report containing several ADRs on the lowest level of detail but within the same PT were counted once.…”

Section: Methodsmentioning

confidence: 99%

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

Vries

Denig

Ekhart

et al. 2019

Brit J Clinical Pharma

116

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Aims We aimed to assess and characterize sex differences in adverse drug reactions (ADRs) reported to the national pharmacovigilance centre in the Netherlands while considering differences in drug use. Methods ADRs spontaneously reported by healthcare professionals and patients to the Netherlands pharmacovigilance centre Lareb were used. Drug–ADR combinations reported at least 10 times between 2003–2016 for drugs used by ≥10,000 persons in that period were included. Data about the number of drug users was obtained from the National Health Care Institute. Sex‐specific ADRs, like gynaecological problems, were excluded. Sex differences in specific drug–ADR combinations were tested using bivariate logistic regression analyses in which the number of drug users per sex was taken into account. Results In total, 2483 drug–ADR combinations were analysed. Possibly relevant sex differences were shown in 363 combinations (15%). Most of these drug–ADR combinations were reported more often for women (322 combinations). Drugs with the highest number of ADRs that were more often reported for women included thyroid hormones (32 combinations) and antidepressants (16 combinations for the centrally acting sympathomimetics; 14 combinations for other antidepressants). Some ADRs were predominantly reported for women across a range of drugs such as headache and dizziness whereas other ADRs such as tendon ruptures and aggression were reported more often for men. Conclusions Identified sex differences in reported ADRs often referred to women. These differences may have various causes, including pharmacological and behavioural causes, which need to be further assessed. The results may ultimately lead to sex‐specific prescribing or monitoring recommendations.

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Section: Methodsmentioning

confidence: 99%

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

Vries

Denig

Ekhart

et al. 2019

Brit J Clinical Pharma

116

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“…It contains 14,160,191 total reports, 8,072,400 serious reports (excluding death) and 1,420,885 death reports. Vigibase (Lindquist, 2008) is a unique World Health Organisation (WHO) global database of individual case safety reports (ICSRs), it is linked to medical and drug classifications, including terminologies such as WHO Adverse Reaction Terminology (ART), Medical Dictionary for Regulatory Activities (MedDRA) (Morley, 2014), WHO International Statistical Classification of Diseases (ICD), the medicinal products dictionary, and WHODrug. It holds over 16 million anonymised reports of suspected adverse effects of medicines suffered by patients.…”

Section: Resultsmentioning

confidence: 99%

In Silico Toxicology Data Resources to Support Read-Across and (Q)SAR

et al. 2019

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A plethora of databases exist online that can assist in in silico chemical or drug safety assessment. However, a systematic review and grouping of databases, based on purpose and information content, consolidated in a single source, has been lacking. To resolve this issue, this review provides a comprehensive listing of the key in silico data resources relevant to: chemical identity and properties, drug action, toxicology (including nano-material toxicity), exposure, omics, pathways, Absorption, Distribution, Metabolism and Elimination (ADME) properties, clinical trials, pharmacovigilance, patents-related databases, biological (genes, enzymes, proteins, other macromolecules etc.) databases, protein-protein interactions (PPIs), environmental exposure related, and finally databases relating to animal alternatives in support of 3Rs policies. More than nine hundred databases were identified and reviewed against criteria relating to accessibility, data coverage, interoperability or application programming interface (API), appropriate identifiers, types of in vitro, in vivo ,-clinical or other data recorded and suitability for modelling, read-across, or similarity searching. This review also specifically addresses the need for solutions for mapping and integration of databases into a common platform for better translatability of preclinical data to clinical data.

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Translation of nonclinical to clinical safety findings for 27 biotherapeutics

Leach,

Rana,

et al. 2024

Toxicology and Applied Pharmacology

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Adverse event reporting: A brief overview of MedDRA

Cited by 4 publications

References 7 publications

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

Sex differences in adverse drug reactions reported to the National Pharmacovigilance Centre in the Netherlands: An explorative observational study

In Silico Toxicology Data Resources to Support Read-Across and (Q)SAR

Translation of nonclinical to clinical safety findings for 27 biotherapeutics

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