Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

Number of patients with any Treatment-Emergent Adverse Events (TEAEs) as reported by the patient's parent and/or caregiver or observed by the treating physician during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).

Number of patients with any serious Treatment-Emergent Adverse Events (TEAEs) during the study (maximum Treatment Period is 12 months plus 2-week safety follow-up).

Number of patients with any Treatment-Emergent Adverse Events (TEAEs) leading to temporary or permanent discontinuation of Keppra® (Levetiracetam) during the Treatment Period (maximum 12 months).

Number of patients with presence of deviation from the normal milestones of psychomotor development during the Treatment Period (maximum 12 months). The treating physician evaluated at each visit, as part of standard clinical practice, the psychomotor development of the patient. The evaluation of the patient's psychomotor development was categorized by the motor development, the social development and the language development.

For each visit, body weight was measured and standardization for gender and age was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the mean of the differences of individual body weight z-scores from Safety Follow-up Visit to Baseline was determined.

For each visit, body length was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of body length z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.

For each visit, head circumference was measured and age standardization was performed based on WHO growth charts to obtain z-scores. For this outcome measure, the difference of head circumference z-scores from Safety Follow-up Visit to Baseline was determined and averaged across the study population.

Number of patients with abnormalities noted during physical examination over the Treatment Period (maximum 12 months). Any abnormal findings during the physical examination during the study were reported as Adverse Events (AEs).

The Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit cannot be given because abnormalities at Screening are listed only and worsening after Screening were handled as AEs and tabulated along with the other AEs.

The Number of Patients With Abnormalities Noted During Neurological Examination cannot be given because abnormality frequencies were only determined for single parameters of the neurological examination and therefore a subject might have been counted several times.

Global evaluation scale of the psychomotor development (GES): physician's assessment of the change from Baseline in the psychomotor development at the last Treatment Visit (maximum timeframe is 12 months). The GES is a 7-point scale with the following options:

7=Marked improvement

6=Moderate improvement

5=Slight improvement

4=No Change

3=Slight worsening

2=Moderate worsening

1=Marked worsening

As a variant of this variable, a 3-class variable was derived as follows

• "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved."
• "No change" was defined as "Stable."
• "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."

Global evaluation scale of epilepsy severity (GES): physician's assessment of the change from Baseline of the epilepsy severity at the last Treatment Visit (maximum 12 months). The GES is a 7-point scale that assesses change in the severity of the patient's illness. The GES is a 7-point scale with the following options:

7=Marked improvement

6=Moderate improvement

5=Slight improvement

4=No Change

3=Slight worsening

2=Moderate worsening

1=Marked worsening

As a variant of this variable, a 3-class variable was derived as follows

• "Marked improvement," "Moderate improvement," and "Slight improvement" were defined as "Improved."
• "No change" was defined as "Stable."
• "Slight worsening," "Moderate worsening," and "Marked worsening" were defined as "Worsened."

Number of patients who withdraw due to lack or loss of efficacy during the Treatment Period (maximum 12 months).