Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 主要终点
- Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
研究概览
简要总结
What AE occur in routine clinical practice, what is the incidence of AE and Adverse Drug Reaction, how many patients present with AE symptoms related to a potential liver injury. What are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Men with spasmodic syndromes
Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
干预措施: Hyoscine n-butylbromide (Drug)
Men with spasmodic syndromes
Men with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
干预措施: Paracetamol (Drug)
Women with spasmodic syndromes
Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
干预措施: Hyoscine n-butylbromide (Drug)
Women with spasmodic syndromes
Women with any type of gastrointestinal, hepato-biliary, urinary or genital spasmodic syndromes
干预措施: Paracetamol (Drug)
结局指标
主要结局
Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
时间窗: From the initial dose of study drug until end of the follow up period, up to 113 days
Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.
次要结局
- Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.(From the initial dose of study drug until end of the follow up period, up to 113 days)
- Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima(From the initial dose of study drug until end of the follow up period, up to 113 days)
- Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment(From the initial dose of study drug until end of the follow up period, up to 113 days)
- Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N(From the initial dose of study drug until end of the follow up period, up to 113 days)