Special Investigation Of J Zoloft For Panic Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 997
- 主要终点
- Number of Participants of Treatment Related Adverse Events (TRAEs)
研究概览
简要总结
The objective of this surveillance is to collect information for panic disorder patients about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
详细描述
All patients with panic disorder to whom an investigator prescribes the first sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with panic disorder need to be taking sertraline hydrochloride in order to be enrolled in the surveillance.
排除标准
- •Patients not taking sertraline hydrochloride.
研究组 & 干预措施
Sertraline hydrochloride.
The patients of Panic disorder taking Sertraline hydrochloride.
干预措施: Sertraline hydrochloride (Drug)
结局指标
主要结局
Number of Participants of Treatment Related Adverse Events (TRAEs)
时间窗: Baseline up to 52 weeks
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Number of Treatment Related Adverse Events (TRAEs) Not Expected From Japanese Package Insert
时间窗: Baseline up to 52 weeks
次要结局
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Starting Dose(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Family History of Psychiatric Disorder(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Smoking Status(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Past Medical History of Other Illness(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Non-Pharmaceutical Therapies(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: History of Treatment Prior to Administration of Sertraline(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Average Daily Dose(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Complications(Baseline up to 52 weeks)
- Factors Considered to Affect the Efficacy of Sertraline: Concomitant Drug(Baseline up to 52 weeks)
- Factors Considered to Affect the Efficacy of Sertraline: Complication(Baseline up to 52 weeks)
- Factors Considered to Affect the Efficacy of Sertraline: Drinking Status(Baseline up to 52 weeks)