Special Investigation Of Long Term Use Of J ZOLOFT.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 542
- 主要终点
- Number of Participants of Treatment Related Adverse Events (TRAEs)
研究概览
简要总结
Special investigation of long term use of sertraline, 52 Week Observation, Long-Term Safety. The objective of this "Special investigation" is to collect information 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 regarding long time use.
详细描述
All the patients for 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
- •The patients who take sertraline hydrochloride for longer than the duration of 16 weeks among the patients enrolled in A0501090 (Drug Use Investigation of J Zoloft).
排除标准
- •Patients not taking sertraline hydrochloride.
研究组 & 干预措施
Sertraline hydrochloride.
Patients 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
- Factors Considered to Affect the Efficacy of Sertraline: Non-Pharmaceutical Therapies(Baseline up to 52 weeks)
- Factors Considered to Affect the Efficacy of Sertraline: Present or Past History of Intentional Suicidal Ideation (Including Suicide Attempt)(Baseline up to 52 weeks)
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction(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)