LORA-PITA IV General Investigation

Completed

Conditions: Status Epilepticus

Interventions: Drug: Lorazepam

Registration Number: NCT03905798

Lead Sponsor: Pfizer

Brief Summary: Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.

Detailed Description: To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA for Status Epilepticus patients in Japan.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 206

Inclusion Criteria

Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lorazepam	Lorazepam	Patients administered Lorazepam in accordance with the indication (for Status Epilepticus, SE) and have no history of using this drug

Primary Outcome Measures

Name	Time	Method
Number of the Participants With Adverse Drug Reactions	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.

Secondary Outcome Measures

Name	Time	Method
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.	Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation. Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure.
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.	Epileptic seizures subject to treatment with LORA-PITA were evaluated as effectiveness evaluation. Definition of responders to the first or second administration of LORA-PITA: A responder was defined as a participant whose seizure resolved within 10 minutes after the first administration of LORA-PITA or the second administration (10 to 30 minutes after the first administration) and who did not require additional treatment with other drugs for the target disease within 30 minutes after the end of administration (excluding prophylactic administration) and had no recurrent seizure.