Trial Outcomes & Findings for Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution (NCT NCT01210690)

Last Updated: 2014-11-19

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

101 participants

Primary outcome timeframe

From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Results posted on

2014-11-19

Participant Flow

It was planned to enroll 100 patients at approximately 30-40 sites in the European Union.

Overall 101 patients were enrolled. The Participant Flow refers to the Enrolled Set (ES). The ES consisted of patients with a signed Data Consent Form.

Participant milestones

Participant milestones
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Overall Study STARTED	101
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	12
Overall Study Lost to Follow-up	3
Overall Study Disease Remission	1
Overall Study Withdrawal by Subject	1
Overall Study Patient refused to swallow	1
Overall Study Patient could not take glucose	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=101 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Age, Continuous	6.0 months STANDARD_DEVIATION 3.0 • n=93 Participants
Age, Customized <1 month	2 participants n=93 Participants
Age, Customized ≥1 - ≤6 months	53 participants n=93 Participants
Age, Customized ≥6 - ≤11 months	46 participants n=93 Participants
Age, Customized >11 months	0 participants n=93 Participants
Sex: Female, Male Female	51 Participants n=93 Participants
Sex: Female, Male Male	50 Participants n=93 Participants
Weight	7.00 kilogram STANDARD_DEVIATION 1.94 • n=93 Participants
Height	64.16 centimeter STANDARD_DEVIATION 8.04 • n=93 Participants

PRIMARY outcome

Timeframe: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=101 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit	55 participants

SECONDARY outcome

Timeframe: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.

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).

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=101 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up	32 participants

SECONDARY outcome

Timeframe: From Baseline through the last Treatment Visit (maximum 12 months)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.

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).

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=101 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit	5 participants

SECONDARY outcome

Timeframe: From Baseline to the last Treatment Visit (maximum 12 months)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication. Presented is the number of subjects with non-missing data on psychomotor development at the corresponding visit.

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.

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=81 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit Any deviation	54 participants
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit Motor development	52 participants
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit Social development	48 participants
Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit Language development	48 participants

SECONDARY outcome

Timeframe: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=18 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit	0.740 z-scores Standard Deviation 1.304

SECONDARY outcome

Timeframe: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=15 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit	0.335 z-scores Standard Deviation 2.058

SECONDARY outcome

Timeframe: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)

Population: The Analysis Population refers to the Safety Set (SS). The SS consisted of all patients in the Enrolled Set who received at least 1 (partial) dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=15 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit	-0.307 z-scores Standard Deviation 1.802

SECONDARY outcome

Timeframe: From Baseline to the last Treatment Visit (maximum 12 months)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to the last Treatment Visit (maximum 12 months)

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Baseline to the last Treatment Visit (maximum 12 months)

Population: The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment. Presented is the number of subjects with a non-missing measurement at Visit 7.

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."

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=85 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Global Evaluation Scale of the Psychomotor Development (GES) Improved	45 participants
Global Evaluation Scale of the Psychomotor Development (GES) Stable	31 participants
Global Evaluation Scale of the Psychomotor Development (GES) Worsened	9 participants

SECONDARY outcome

Timeframe: From Baseline to the last Treatment Visit (maximum time frame is 12 months)

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."

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=85 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Global Evaluation Scale of Epilepsy Severity (GES) Improved	61 participants
Global Evaluation Scale of Epilepsy Severity (GES) Stable	16 participants
Global Evaluation Scale of Epilepsy Severity (GES) Worsened	8 participants

SECONDARY outcome

Timeframe: From Baseline through the last Treatment Visit (maximum 12 months)

Population: The Analysis Population refers to the Full Analysis Set (FAS). The FAS consisted of all patients in the Enrolled Set who had at least 1 post-Baseline efficacy assessment.

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

Outcome measures

Outcome measures
Measure	Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution n=101 Participants Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period	12 participants

Adverse Events

Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution

Serious events: 32 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution n=101 participants at risk Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Gastrointestinal disorders Diarrhoea	2.0% 2/101 • Number of events 2 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Gastrointestinal disorders Vomiting	2.0% 2/101 • Number of events 3 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
General disorders Drug withdrawal syndrome	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
General disorders Pyrexia	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Bronchiolitis	2.0% 2/101 • Number of events 2 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Bronchitis	2.0% 2/101 • Number of events 2 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Gastroenteritis	2.0% 2/101 • Number of events 2 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Lower respiratory tract infection	2.0% 2/101 • Number of events 3 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Candida infection	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Device related infection	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Gastroenteritis viral	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Lung infection	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Otitis media	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Pneumonia viral	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Upper respiratory tract infection	0.99% 1/101 • Number of events 2 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Urinary tract infection	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Viral infection	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Injury, poisoning and procedural complications Lower limb fracture	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Nervous system disorders Convulsion	9.9% 10/101 • Number of events 15 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Nervous system disorders Epilepsy	3.0% 3/101 • Number of events 5 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Nervous system disorders Hydrocephalus	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Nervous system disorders Hyperkinesia	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Nervous system disorders Infantile spasms	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Nervous system disorders Status epilepticus	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Psychiatric disorders Inappropriate affect	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Psychiatric disorders Sleep disorder	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	2.0% 2/101 • Number of events 3 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.0% 2/101 • Number of events 2 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Respiratory, thoracic and mediastinal disorders Apnoea	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Surgical and medical procedures Neurosurgery	0.99% 1/101 • Number of events 1 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.

Other adverse events

Other adverse events
Measure	Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution n=101 participants at risk Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
Gastrointestinal disorders Diarrhoea	5.9% 6/101 • Number of events 8 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
General disorders Pyrexia	6.9% 7/101 • Number of events 8 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.
Infections and infestations Bronchitis	8.9% 9/101 • Number of events 11 • Treatment emergent Adverse Events (TEAEs) were reported from Baseline through the Safety Follow-up Visit. Treatment emergent Adverse Events (AEs) are AEs with onset date (including severity-worsening) on or after first dose of study medication.

Additional Information

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Principal investigator is a sponsor employee
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