NCT02345343已完成不适用
Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月4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
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians
研究概览
简要总结
The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.
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
- •Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE during the specified 24-month study period
排除标准
- •Subjects who received apixaban as part of a clinical trial
- •Subjects who received apixaban for any indication other than local approved
- •Contraindications included in the approved Mexican prescribing information
研究组 & 干预措施
Drug: Apixaban
Patients with VTE who are being given apixaban for the treatment and/or prevention of recurrence of DVT and PE at the sentinel site
干预措施: Apixaban (Drug)
结局指标
主要结局
The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians
时间窗: Up to 24-month study period
次要结局
- The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE(Up to 24-month study period)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Early Post-marketing Study of Eliquis (Apixaban)Non-valvular Atrial Fibrillation (NVAF)NCT02153424Bristol-Myers Squibb
已完成
不适用
Eliquis Regulatory Post Marketing SurveillanceNonValvular Atrial FibrillationNCT01885598Bristol-Myers Squibb3,335
撤回
不适用
Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in AdultsHepatitis CNCT03208322Bristol-Myers Squibb
已完成
不适用
Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Hypertension, PulmonaryNCT01406327GlaxoSmithKline900
已完成
1 期
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19HealthyChronic Stable IllnessNCT04519437Regeneron Pharmaceuticals974