A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age

The percent difference in partial seizure frequency per week at Baseline and Study Visit 4 (Week 2) was computed as: {[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 4)] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.

The percent difference in partial seizure frequency per week at Baseline and Study Visit 5 (Week 4) was computed as: {[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 5)] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.

Percent difference in partial seizure frequency (PSF) per week at each Analysis Visit: {[(Number of partial seizures per week at Baseline [BL]) - (Number of partial seizures per week at analysis visit X)]/(Number of partial seizures per week at BL)}*100. Positive value indicates reduction in PSF from BL. End of study (EOS)/early discontinuation visit (EDV) was based on last EDV and calculation of number of partial seizure per week were based on the period from the previous EDV visit. The mapping of seizure data to Analysis Visits was based on target dates of the visits. A seizure date after that of target date of an Analysis Visit n and up to that of target date of next Analysis Visit n+1 was mapped to the next Analysis Visit (n+1). Data for one participant assessed within study duration was mapped to Analysis Visit 35/Week 300 based on statistical plan.

Percent difference in PSF per week on adjunctive therapy at BL and each analysis visit: {[(Number of partial seizures per week at BL) - (Number of partial seizures per week at analysis visit X)]/(Number of partial seizures per week at BL)}*100. Percent difference in PSF per week from Baseline for each participant and analysis visit were mapped into 6 categories: <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, and 100%, then percentages of participants in these categories were derived using the number of participants at risk at each previous analysis visit as denominator. Positive value in percent difference from Baseline indicates reduction in PSF from Baseline. The mapping of seizure data to Analysis Visits was based on target dates of visits. A seizure date after that of target date of an Analysis Visit n and up to that of target date of next Analysis Visit n+1 was mapped to next Analysis Visit (n+1).

The percent difference in partial seizure frequency per week on monotherapy at Baseline and each analysis visit was computed as: {[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at analysis visit X)] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on monotherapy. The maximum duration of study participation in monotherapy participants was shorter than in adjunctive therapy. Therefore, data at Week 288 and 300 is not reported for Monotherapy.

Percent difference in PSF per week on monotherapy at BL and each analysis visit: {[(Number of partial seizures per week at BL) - (Number of partial seizures per week at analysis visit X)]/(Number of partial seizures per week at BL)}*100. Percent difference in PFS per week from Baseline for each participant and analysis visit were mapped into 6 categories: <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, and 100%, then percentages of participants in these categories were derived using the number of participants at risk at each previous analysis visit as denominator. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on monotherapy. Maximum duration of study participation in monotherapy participants was shorter than adjunctive therapy. Therefore, data at Week 288 and 300 is not reported for Monotherapy.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation Participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The treatment-emergent adverse events (TEAEs) were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.

A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that must meet 1 or more of the following criteria: Death; Life-threatening; Significant or persistent disability/incapacity; Congenital anomaly/birth defect (including that occurring in a fetus); Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious; Initial inpatient hospitalization or prolongation of hospitalization. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs leading to discontinuation from study medication are reported.

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.

A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that must meet 1 or more of the following criteria: Death; Life-threatening; Significant or persistent disability/incapacity; Congenital anomaly/birth defect (including that occurring in a fetus); Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious; Initial inpatient hospitalization or prolongation of hospitalization. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.

An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs leading to discontinuation from study medication are reported.