Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline
研究概览
简要总结
Effectiveness of risk minimisation interventions for vandetanib in Canada
详细描述
As part of the new drug approval process in Canada, AstraZeneca has committed to Health Canada to conduct a Drug Utilization Study among patients recently treated with CAPRELSA (vandetanib) and a Knowledge and Understanding Survey among the prescribing physicians to determine whether the product monograph, communication plan, and educational material developed by AstraZeneca Canada for vandetanib are adequate to provide knowledge about the potential risks associated with this product, and if other medications taken concomitantly with vandetanib are managed adequately.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •N/A (all patients taking Caprelsa and all prescribers will be contacted for participation).
排除标准
- 未提供
结局指标
主要结局
Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline
时间窗: At baseline
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months
时间窗: At 3 months
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months
时间窗: At 12 months
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - dosage at 6 months
时间窗: At 6 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline
时间窗: At baseline
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib
时间窗: 2 months
QT prolongation/TdP Torsades, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response).
Drug Utilisation Study: Use of vandetanib - dosage at baseline
时间窗: At baseline
Drug Utilisation Study: Use of vandetanib - dosage at 12 months
时间窗: At 12 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months
时间窗: At 3 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months
时间窗: At 12 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months
时间窗: At 6 months
Discontinuation, interruption, continuous
Drug Utilisation Study: Use of vandetanib - dosage at 3 months
时间窗: At 3 months
Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months
时间窗: At 6 months
Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
次要结局
- Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training(2 months)
- Knowledge and Understanding Survey: Practice characteristics(2 months)
- Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib(2 months)