Results
status epilepticus, pseudoseizures, Coma, seizure, Seizure, convulsive
STATUS EPILEPTICUS, ADVERSE EVENTS, COMA
Among the 176 adult patients with convulsive SE enrolled during the study period, 82 were assigned to the FPHT group and 94 to the LEV group. The protocol was performed and completed on all patients. We did not obtain consent from 13 patients because they were unconscious and there was no proxy during hospitalisation, and we included them in the analysis according to the study design. No patient rejected enrolment after providing informed consent. Following considerations of safety, seven patients were administered 500 mg of LEV only, while one patient was administered 120 mg of FPHT only. Other protocol deviations were not observed. We included these eight patients in the analysis set. Three out of the 176 patients enrolled, 2 in the FPHT group and 1 in the LEV group, were diagnosed with pseudoseizures and removed from the analysis. Therefore, we included 176 patients in SAS and 173 patients in FAS after the exclusion of 3 dropout patients. The study outline and main outcomes are shown in Study outline and outcomes. The study protocol was immediately performed on patients with status epilepticus who met the eligibility criteria in the emergency department. Registration was simultaneously conducted with the administration of diazepam and patients were randomised to the FPHT or LEV group. In both groups, diazepam was intravenously administered at 1–20 mg. In the 82 patients in the FPHT group, FPHT was intravenously administered at 22.5 mg/kg after diazepam at an administration rate not exceeding 3 mg/kg/min or 150 mg/min. In the 94 patients in the LEV group, LEV was intravenously administered at 1000–3000 mg after diazepam at an administration rate of 2–5 mg/kg/min. Two patients in the FPHT group and one in the LEV group were excluded because they were diagnosed with pseudoseizures. Seizure cessation rates within 30 min were 83.8% in the FPHT group and 89.2% in the LEV group. DIV, drip intravenous injection;FPHT, fosphenytoin; IV, intravenously; LEV, levetiracetam;JCS, Japan Coma Scale.Basic characteristics are shown in 
Basic characteristicsOthers were causes other than those listed, which each physician was unable to categorise. Continuous variables with a normal distribution are expressed as the mean±SD and compared using the Student’s t-test. Non-parametric continuous variables are expressed as medians (IQRs) and compared using the Mann-Whitney U test. Categorical variables are expressed as n (%) and compared using the χFPHT, fosphenytoin; LEV, levetiracetam.Others were causes other than those listed, which each physician was unable to categorise. Continuous variables with a normal distribution are expressed as the mean±SD and compared using the Student’s t-test. Non-parametric continuous variables are expressed as medians (IQRs) and compared using the Mann-Whitney U test. Categorical variables are expressed as n (%) and compared using the χTreatments are shown in Treatments for status epilepticusEach variable is expressed as a median (IQR) and compared using the Mann-Whitney U test.FPHT, fosphenytoin; LEV, levetiracetam.As the primary outcome, seizure cessation rates within 30 min from study drug administration were 83.8% (67/80) in the FPHT group and 89.2% (83/93) in the LEV group (OutcomesEach variable is expressed as n (%) and compared using the χFPHT, fosphenytoin; LEV, levetiracetam.The occurrence of serious adverse events related to the study drugs is shown in Serious adverse events related to study drugsEach variable is expressed as n (%) and compared using the χFPHT, fosphenytoin; LEV, levetiracetam.