An Open Label, Non-interventional Study Of The Safety Of Desvenlafaxine Succinate (Pristiq) In The Treatment Of Major Depressive Disorder (Mdd) And Vasomotor Symptoms (Vms) Associated With Menopause In Filipino Adult Patients: A Post Marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
研究概览
简要总结
This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.
详细描述
post marketing surveillance none
研究设计
- 研究类型
- Observational
- 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 diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate
排除标准
- •Hypersensitivity to desvenlafaxine succinate
研究组 & 干预措施
1
干预措施: desvenlafaxine succinate (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
时间窗: Week 4 to Week 8
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
时间窗: Week 4
Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
时间窗: Week 8
Change From Baseline in Heart Rate at Week 4.
时间窗: Week 4
Change From Baseline in Heart Rate at Week 8.
时间窗: Week 8
Change From Baseline in Weight at Week 4.
时间窗: Week 4
Change From Baseline in Weight at Week 8.
时间窗: Week 8
次要结局
未报告次要终点