Clinical signs listed in Periodic Safety Update report data submitted to the VMD

The dataset includes all the clinical signs included in the line listings submitted with periodic safety update reports submitted to the Veterinary Medicines Directorate during a one year period. Periodic safety update reports have to be submitted to the VMD for all authorised veterinary medicines at intervals set in legislation, depending on how long the product has been on the market. These reports should include all adverse events to which the marketing authorisation holder has been made aware of during that reporting period.
Individual products are not identified by product names but by therapeutic group. The dataset includes clinical signs classified according VeDDRA terminology:

SOC = system organ class

HLT = higher level term

PT = preferred term

LLT = lower level term.

Further information on VeDDRA can be found at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000173.jsp&mid=WC0b01ac058002dea6#section3

本数据集囊括了在一年内提交给兽医药品管理局的定期安全更新报告中所包含的所有临床体征。根据法规规定的时间间隔，所有获准的兽医药品均需向VMD提交定期安全更新报告，其间隔取决于产品上市的时间长短。这些报告应包含在该报告期内，营销授权持有人已知的所有不良事件。各产品并非通过产品名称进行标识，而是通过治疗类别进行区分。数据集包含按照VeDDRA术语体系进行分类的临床体征：

SOC = 系统器官类别

HLT = 高级术语

PT = 优选术语

LLT = 低级术语。关于VeDDRA的更多信息，请参阅http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000173.jsp&mid=WC0b01ac058002dea6#section3。