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临床试验/NCT01685424
NCT01685424已完成不适用

Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis

Organon and Co0 个研究点目标入组 79,189 人开始时间: 2006年6月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
79,189
主要终点
Dose of Initial Etoricoxib Prescription

研究概览

简要总结

This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse.

排除标准

  • Not registered in a GPRD-contributing practice that had continuously
  • collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December
  • Never registered as a permanent patient of a General Practitioner in the practice
  • Registration details were not acceptable (i.e. incomplete data or logically implausible dates)
  • Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD

研究组 & 干预措施

Etoricoxib Prescription (Period 1)

First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005

干预措施: Etoricoxib (Drug)

Etoricoxib Prescription (Period 2)

First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015

干预措施: Etoricoxib (Drug)

Repeat Etoricoxib Prescription

One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2.

干预措施: Etoricoxib (Drug)

结局指标

主要结局

Dose of Initial Etoricoxib Prescription

时间窗: At first prescription (during a time period up to 13.75 years)

Duration of Initial Etoricoxib Prescription

时间窗: At first prescription (during a time period up to 13.75 years)

Participant's Baseline Characteristics (Demographics and Medical)

时间窗: At first prescription (during a time period up to 13.75 years)

Incidence of Adverse Events of Special Interest Among Etoricoxib Users

时间窗: During a time period up to 13.75 years

次要结局

  • "Off-label" use of Etoricoxib(At first prescription (during a time period up to 13.75 years))

研究者

申办方类型
Industry
责任方
Sponsor

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