A Survey of Midazolam in People With Status Epilepticus

Primary outcomes

1. Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)

   Time frame: Up to 24 hours after drug administration

   An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product (including an investigational product for a new indication in Japan), whether or not related to the pharmaceutical product.

2. Number of Participants With Serious Adverse Events

   Time frame: Up to 24 hours after drug administration

   A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

3. Number of Participants With Therapeutic Success

   Time frame: Up to 30 minutes after drug administration

   Therapeutic success is defined as cessation of seizure activity within 10 minutes and sustained absence of seizure activity for 30 minutes following the first dose of midazolam oromucosal solution. Number of participants with therapeutic success will be reported.