Status Epilepticus
Conditions
Keywords
Status Epilepticus;, Lorazepam;, LORA-PITA;, Ativan
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.
Interventions
DRUGLorazepam
The usual dose of lorazepam in adults is 4 mg administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 4 mg may be added but the dose should not exceed 8 mg as the sum of initial and additional doses. The usual dose of lorazepam in children aged 3 months or older is 0.05 mg/kg (up to 4 mg) administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 0.05 mg/kg may be added but the dose should not exceed 0.1 mg/kg as the sum of initial and additional doses.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Patients administered Lorazepam in accordance with the indication (for Status Epilepticus) and have no history of using this drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LORA-PITA Intravenous Injection 2mg (Lorazepam) This study was conducted by fixed-point all participants surveillance system in participants who received LORA-PITA as indicated in the approved local product document. The observation period was from the first dose received to 24 hours after the last dose received. A follow-up period was 24 hours after the end of the last dose, and if the follow-up period was less than 24 hours, such participants were deemed as withdrawals.
The pediatric (\< 16 years) and adult (≥ 16 years) participants' initial doses were 0.25 to 4.00 mg (0.025 to 0.098 mg/kg) and 1.50 to 4.00 mg, respectively. The pediatric and adult participants' second doses were 0.40 to 2.00 mg (0.024 to 0.050 mg/kg) and 2.00 to 4.00 mg, respectively. The pediatric and adult participants' third doses were 0.80 mg (0.024 mg/kg) and 2.00 to 4.00 mg, respectively. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No informed consent for notification/publication of study results | 94 |
Baseline characteristics
| Characteristic | LORA-PITA Intravenous Injection 2mg (Lorazepam) | — |
|---|---|---|
| Age, Customized ≥16 and <65 years | 40 Participants | — |
| Age, Customized <16 years | 23 Participants | — |
| Age, Customized ≥65 years | 49 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 49 Participants | — |
| Sex: Female, Male Male | 63 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 112 |
| other Total, other adverse events | 9 / 112 |
| serious Total, serious adverse events | 1 / 112 |
Outcome results
Primary
Number of the Participants With Adverse Drug Reactions
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.
Time frame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received LORA-PITA at least once. Participants without informed consent for notification/publication of study results were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LORA-PITA Intravenous Injection 2mg (Lorazepam) | Number of the Participants With Adverse Drug Reactions | 7 Participants |
Secondary
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)
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.
Time frame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Population: The efficacy analysis set (104 participants) comprised of participants in the safety analysis set in whom LORA-PITA was used and had evaluable effectiveness data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LORA-PITA Intravenous Injection 2mg (Lorazepam) | 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) | 62.5 Percentage of Participants |
Secondary
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)
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.
Time frame: From the first dose of LORAPITA to 24 hours after the end of the last dose, up to approximately 2 days.
Population: The efficacy analysis set (84 participants) comprised of participants in the safety analysis set in whom LORA-PITA was used as the first-line treatment with evaluable effectiveness, excluding participants who met any of the following conditions: effectiveness evaluation has not been reported at all or the administration was as the second-line treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LORA-PITA Intravenous Injection 2mg (Lorazepam) | 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) | 64.3 Percentage of Participants |