Rechallenge of Rapidly Accelerated Fibrosarcoma B-type (BRAF) +/- Mitogen-activated Extracellular Signal-regulated Kinase (MEK) Inhibitors Following an Adverse Event in Patients With Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 16,000
- 主要终点
- Recurrence rate
研究概览
简要总结
Very little data are published on the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE). This study aimed at identifying the recurrence rate of the same AE after a BRAFi +/- MEKi rechallenge in patients with cancer and the factors associated to the recurrence.
详细描述
This is an observational, cross-sectional, pharmacovigilance cohort study. AEs were extracted from safety reports from the World Health Organization database VigiBase®, to evaluate the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE) in patients with cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive AE cases associated with BRAFi and MEKi therapy. Combination therapy cases, where BRAFi were concurrently reported with MEKi will be identified, as well as the combination therapy regimen (V+C, D+T, E+B). We will not study MEKi monotherapy cases
排除标准
- •MEKi monotherapy cases
- •Cases concurrently reporting on immune checkpoint inhibitor therapies
研究组 & 干预措施
Reports of adverse events associated with the use of BRAF +/- MEK inhibitors
Reports of adverse event (individual case safety reports) from Vigibase, the World Health Organization pharmacovigilance database related to the use of BRAF +/- MEK inhibitors from inception (1986) until March, 1, 2021 will be extracted.
Cases concurrently reporting on immune checkpoint inhibitor therapies will be excluded.
干预措施: BRAF inhibitor (Drug)
结局指标
主要结局
Recurrence rate
时间窗: Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years
The primary outcome is the rate of recurrence of the same AE after a BRAFi+/- MEKi rechallenge among informative rechallenges The recurrence rate will be obtained by dividing the number of cases with an AE recurrence by the number of informative rechallenges and will be expressed as a percentage
次要结局
- Comparison of rechallenge and non-rechallenge cases(Up to 10 years)
- Factors associated with the recurrence after a rechallenge among informative rechallenges (i.e. variables associated with a higher recurrence rate, in a regression model)(Up to 10 years)
- Rate of occurrence of a different AE after a monotherapy or combination therapy rechallenge (among informative rechallenges)(Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years)