LORA-PITA (REGISTERED) Intravenous Injection 2 mg General Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Number of the Participants With Adverse Drug Reactions
研究概览
简要总结
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
详细描述
To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
排除标准
- 未提供
研究组 & 干预措施
Lorazepam
Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug
干预措施: Lorazepam (Drug)
结局指标
主要结局
Number of the Participants With Adverse Drug Reactions
时间窗: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to LORA-PITA in a participant who received LORA-PITA. A serious adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to LORA-PITA was assessed by the physician.
次要结局
- Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Participants in Whom LORA-PITA Was Used as the First-line Treatment)(From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.)
- Proportion of Participants Whose Initial Seizure Stopped Within 10 Minutes After the Administration of Final Dose and Who Continued Seizure-free for at Least 30 Minutes (Efficacy Analysis Set)(From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.)