Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

• ClinicalTrials.gov Identifier: NCT01364597
• Recruitment Status: Completed
• First Posted: June 2, 2011
• Results First Posted: August 29, 2022
• Last Update Posted: November 14, 2022
• Sponsor: UCB Pharma SA
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Brivaracetam (BRV)
• Enrollment: 257

Participant Flow

Recruitment Details	The study started to enroll participants in August 2011 and concluded in February 2022.
Pre-assignment Details	The Participant Flow refers to the Enrolled Set.

Arm/Group Title	Age Cohort: ≥1 Month to <2 Years	Age Cohort: ≥2 to <4 Years	Age Cohort: ≥4 to <12 Years	Age Cohort: ≥12 to <17 Years
Arm/Group Description	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422], EP0065 [NCT03405714] or N01349 [NCT03325439]) aged greater than or equal to (≥) 1 month to less than (<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily[bid]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥2 Years to <4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥4 Years to <12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to <12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥12 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Period Title: Overall Study
Started	36	15	141	65
Directly Enrolled (DE) Participants	0	0	85	35
Long-term Follow-up (LTFU) Participants	36	15	56	30
Completed	18	4	65	37
Not Completed	18	11	76	28
Reason Not Completed
Adverse Event	4	5	16	7
Lack of Efficacy	4	4	23	8
Protocol Violation	0	0	2	0
Lost to Follow-up	0	0	5	3
Withdrawal by Subject	4	1	18	6
Non compliance	1	0	1	0
Lack of compliance	1	0	0	0
End of treatment epilepsy	1	0	0	0
No Seizures	1	0	0	0
Lack of reliability from the subject's caregiver	1	0	0	0
Cure	1	0	0	0
Patient was moving	0	1	0	0
Seizures resolved	0	0	1	0
Patient became seizure-free after surgery	0	0	1	0
5 year without seizures. Treatment is finish	0	0	1	0
Patient cured from Epilepsy	0	0	1	0
Investigator decision	0	0	1	0
Sponsor recommended discontinuation	0	0	0	1
Parents went abroad with the patient	0	0	1	0
BRV discontinued as no seizures during 2 years	0	0	1	0
BRV administration dropout	0	0	1	0
Dropout	0	0	3	1
Unreliable subject	0	0	0	1
Other	0	0	0	1

Baseline Characteristics

Arm/Group Title		Age Cohort: ≥1 Month to <2 Years	Age Cohort: ≥2 to <4 Years	Age Cohort: ≥4 to <12 Years	Age Cohort: ≥12 to <17 Years	Total
Arm/Group Description		Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422], EP0065 [NCT03405714] or N01349 [NCT03325439]) aged greater than or equal to (≥) 1 month to less than (<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily[bid]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥2 Years to <4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥4 Years to <12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to <12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥12 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Total of all reporting groups
Overall Number of Baseline Participants		36	15	141	65	257
Baseline Analysis Population Description		Baseline characteristics refers to the Enrolled Set (ES) which included all study participants with epilepsy who gave informed consent, or for whom informed consent was given by parent(s)/legal representative(s).
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	36 participants	15 participants	141 participants	65 participants	257 participants
	<=18 years	36 100.0%	15 100.0%	141 100.0%	65 100.0%	257 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	36 participants	15 participants	141 participants	65 participants	257 participants
		1.122 (0.504)	2.761 (0.582)	7.699 (2.394)	13.824 (1.274)	8.039 (4.529)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	36 participants	15 participants	141 participants	65 participants	257 participants
	Female	19 52.8%	5 33.3%	62 44.0%	30 46.2%	116 45.1%
	Male	17 47.2%	10 66.7%	79 56.0%	35 53.8%	141 54.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	36 participants	15 participants	141 participants	65 participants	257 participants
American Indian/ Alaskan native		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Asian		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Black		0 0.0%	0 0.0%	2 1.4%	2 3.1%	4 1.6%
Native Hawaiian or other Pacific Islander		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
White		28 77.8%	14 93.3%	107 75.9%	48 73.8%	197 76.7%
Other/Mixed		8 22.2%	1 6.7%	32 22.7%	15 23.1%	56 21.8%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	36 participants	15 participants	141 participants	65 participants	257 participants
Hispanic or Latino		11 30.6%	1 6.7%	38 27.0%	19 29.2%	69 26.8%
Not Hispanic or Latino		24 66.7%	14 93.3%	103 73.0%	46 70.8%	187 72.8%
Missing		1 2.8%	0 0.0%	0 0.0%	0 0.0%	1 0.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Description	TEAEs are defined as AEs that had onset on or after the day of first BRV dose.
Time Frame	From Baseline to end of study (up to 10 years)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all enrolled participants who took at least 1 dose of study medication.

Arm/Group Title	Age Cohort: ≥1 Month to <2 Years	Age Cohort: ≥2 to <4 Years	Age Cohort: ≥4 to <12 Years	Age Cohort: ≥12 to <17 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422], EP0065 [NCT03405714] or N01349 [NCT03325439]) aged greater than or equal to (≥) 1 month to less than (<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily[bid]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥2 Years to <4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥4 Years to <12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to <12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥12 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	36	15	141	65
Measure Type: Number; Unit of Measure: percentage of participants
	94.4	93.3	93.6	92.3

2. Primary Outcome

Title	Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
Description	TEAEs are defined as AEs that had onset on or after the day of first BRV dose. A SAE was defined as an event that met 1 or more of the below criteria: a) Death, b) Life-threatening, (Life-threatening did not include a reaction that might have caused death had it occurred in a more severe form.) c) Significant or persistent disability/incapacity, d) Congenital anomaly/birth defect (including that occurring in a fetus), e) Important medical event that, based upon appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious, (Important medical events may have included allergic bronchospasm requiring intensive treatment in an emergency room [ER] or at home) f) Initial inpatient hospitalization or prolongation of hospitalization. (A participant admitted to a hospital, even if released on the same day, met the criteria for the initial inpatient hospitalization).
Time Frame	From Baseline to end of study (up to 10 years)

Outcome Measure Data

Analysis Population Description

The Safety Set (SS) consisted of all enrolled participants who took at least 1 dose of study medication.

Arm/Group Title	Age Cohort: ≥1 Month to <2 Years	Age Cohort: ≥2 to <4 Years	Age Cohort: ≥4 to <12 Years	Age Cohort: ≥12 to <17 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422], EP0065 [NCT03405714] or N01349 [NCT03325439]) aged greater than or equal to (≥) 1 month to less than (<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily[bid]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥2 Years to <4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥4 Years to <12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to <12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.	Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥12 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	36	15	141	65
Measure Type: Number; Unit of Measure: percentage of participants
	38.9	53.3	29.8	29.2

3. Secondary Outcome

Title	Absolute Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on Daily Record Card [DRC])
Description	Absolute change in seizure frequency per 28 days based on the daily record card (DRC) data, is calculated as baseline seizure frequency per 28 days minus post-Baseline seizure frequency per 28 days. The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. This OM was analyzed in participants ≥2 years (per DRC data) only. Here in the study FAS indicates Full Analysis Set, EEG indicates electroencephalogram, OM indicates Outcome measure
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (≥2 years only [per DRC data]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for <2 years) from which their seizure data is recorded.

Arm/Group Title	Brivaracetam (BRV): Participants ≥ 2 Years to <17 Years
Arm/Group Description:	Participants from core study (LTFU participants from N01263 [NCT00422422]) aged ≥2 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥4 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	134
Mean (Standard Deviation); Unit of Measure: seizure frequency per 28-days
	-37.48 (628.34)

4. Secondary Outcome

Title	Percent Change in 28-days Adjusted Partial-onset-seizure (POS) Frequency for Participants Aged ≥2 Years From Baseline to the End of the Evaluation Period in Participants With POS Only (Based on DRC Data)
Description	Percent change is calculated as absolute change in seizure frequency per 28 days divided by baseline seizure frequency per 28 Days multiplied to 100. The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28. This OM was analyzed in participants ≥2 years (per DRC data) only.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (≥2 years only [per DRC data]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for <2 years) from which their seizure data is recorded.

Arm/Group Title	Brivaracetam (BRV): Participants ≥ 2 Years to <17 Years
Arm/Group Description:	Participants from core study (LTFU participants from N01263 [NCT00422422]) aged ≥2 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥4 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	105
Mean (Standard Deviation); Unit of Measure: percent change
	26.57 (123.06)

5. Secondary Outcome

Title	50% Responder Rate for Participants ≥2 Years of Age for Total Seizures (All Types) (Based on DRC Data)
Description	A responder is defined as a participant with a ≥50% reduction in seizure frequency from the baseline period of the previous study for LTFU participants or during this study for DE participants. This OM was analyzed in participants ≥2 years (per DRC data) only.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422]; and DE participants: Baseline of current study) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

FAS: all enrolled participants who took at least 1 dose of study drug in this Long-term study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed included all participants evaluable for this OM. Per planned analysis, participants were grouped as per cohort linked to source (DRC for ≥2 years /EEG for <2 years) from which their seizure data is recorded. This OM was analyzed in participants ≥2 years of age (per DRC data) only.

Arm/Group Title	Brivaracetam (BRV): Participants ≥2 Years to <17 Years
Arm/Group Description:	Participants from core study (LTFU participants from N01263 [NCT00422422]) aged ≥2 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥4 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	167
Measure Type: Number; Unit of Measure: percentage of participants
	50.9

6. Secondary Outcome

Title	Absolute Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data)
Description	Absolute change in ADF is calculated as the baseline ADF minus post-baseline ADF. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24. This OM was analyzed in participants <2 years (per EEG data) only.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (<2 years only [per EEG data]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for <2 years) from which their seizure data is recorded.

Arm/Group Title	Brivaracetam (BRV): Participants ≥1 Month to <2 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422] or N01349 [NCT03325439]) aged ≥1 month to <2 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: seizures per day
	2.56 (4.44)

7. Secondary Outcome

Title	Percent Change in Average Daily Frequency (ADF) of Partial-onset-seizures (POS) in Participants <2 Years of Age With POS Only (Based on EEG Data)
Description	Percent change in average daily frequency (ADF) is calculated as absolute change in ADF divided by baseline ADF multiplied to 100. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24. This OM was analyzed in participants <2 years (per EEG data) only.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (<2 years only [per EEG data]) evaluable for this OM and it differs in absolute and percent change OMs as later cannot be analyzed with 0 baseline ADF. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for <2 years) from which their seizure data is recorded.

Arm/Group Title	Brivaracetam (BRV): Participants ≥1 Month to <2 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422] or N01349 [NCT03325439]) aged ≥1 month to <2 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	3
Mean (Standard Deviation); Unit of Measure: percent change
	98.72 (2.22)

8. Secondary Outcome

Title	50% Responder Rate for Participants <2 Years of Age for Total Seizures (All Types) (Based on EEG Data)
Description	A responder is defined as a participant with a ≥50% reduction in seizure frequency from the baseline period of the previous study for LTFU participants. This OM was analyzed in participants <2 years (per EEG data) only.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

FAS: enrolled participants who had at least 1 dose of study drug in the study and had at least 1 completed post-baseline DRC or EEG. Overall number of participants analyzed consist of all participants (<2 years only [per EEG data]) evaluable for this OM. Per plan, participants were grouped per cohort linked to source (DRC for ≥2 years/EEG for <2 years) from which their seizure data is recorded.

Arm/Group Title	Brivaracetam (BRV): Participants ≥1 Month to <2 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422] or N01349 [NCT03325439]) aged ≥1 month to <2 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	8
Measure Type: Number; Unit of Measure: percentage of participants
	75.0

9. Secondary Outcome

Title	Absolute Change in Average Daily Frequency of POS in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data)
Description	Absolute change in ADF is calculated as the baseline ADF minus post-baseline ADF. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

Typical absence seizures data was not collected and analyzed.

Arm/Group Title	Brivaracetam (BRV): Participants ≥1 Month to <2 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422] or N01349 [NCT03325439]) aged ≥1 month to <2 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Percent Change in Average Daily Frequency of POS in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data)
Description	Percent change in average daily frequency (ADF) is calculated as absolute change in ADF divided by baseline ADF multiplied to 100. ADF is calculated as (number of seizures from central reader divided by stop date and time of EEG minus start date and time of EEG) multiplied to 60, multiplied to 24.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

Typical absence seizures data was not collected and analyzed.

Arm/Group Title	Brivaracetam (BRV): Participants ≥1 Month to <2 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422] or N01349 [NCT03325439]) aged ≥1 month to <2 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

11. Secondary Outcome

Title	50% Responder Rate for Total Seizures (All Types) in Participants <2 Years of Age With Typical Absence Seizures (Based on EEG Data)
Description	A responder is defined as a participant with a ≥50% reduction in seizure frequency from the baseline period of the previous study for LTFU participants.
Time Frame	From Baseline (LTFU participants: Baseline of previous studies N01263 [NCT00422422] or N01349 [NCT03325439]) to the end of the evaluation period (up to 10 years)

Outcome Measure Data

Analysis Population Description

Typical absence seizures data was not collected and analyzed.

Arm/Group Title	Brivaracetam (BRV): Participants ≥1 Month to <2 Years
Arm/Group Description:	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422] or N01349 [NCT03325439]) aged ≥1 month to <2 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	From Baseline to end of Study (up to 10 years)
Adverse Event Reporting Description	TEAEs are defined as AEs that had onset on or after the day of first BRV dose.
Arm/Group Title	Age Cohort: ≥1 Month to <2 Years		Age Cohort: ≥2 to <4 Years		Age Cohort: ≥4 to <12 Years		Age Cohort: ≥12 to <17 Years
Arm/Group Description	Participants from core study (LTFU [Long term follow-up] participants from N01263 [NCT00422422], EP0065 [NCT03405714] or N01349 [NCT03325439]) aged greater than or equal to (≥) 1 month to less than (<) 2 years entered evaluation period (EP) and received individualized Brivaracetam (BRV) dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 milligrams per kilogram per day (mg/kg/day) (0.5, 1, 2, and 2.5 mg/kg twice daily[bid]), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the investigational medicinal product (IMP) development was stopped by the Sponsor.		Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥2 Years to <4 years entered EP and received individualized BRV dose as they were receiving at completion of core study. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5mg/kg bid), not to exceed a dose of 200mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.		Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥4 Years to <12 years entered EP and received individualized BRV dose as they were receiving at completion of core study and Directly Enrolled (DE) participants in this study aged ≥4 years to <12 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.		Participants from core study (LTFU participants from N01263 [NCT00422422] and EP0065 [NCT03405714]) aged ≥12 Years to <17 years entered EP and received individualized BRV dose as they were receiving at completion of core study and DE participants in this study aged ≥12 years to <17 years of age received BRV dose based on tolerability confirmed during screening period. For all participants, the approximate BRV doses to be administered are 1 to 5 mg/kg/day (0.5, 1, 2, and 2.5 mg/kg bid), tablet or oral solution and can be up-titrated or down-titrated based on investigator decision with a maximum allowable BRV dose of 5.0 mg/kg/day (2.5 mg/kg bid), not to exceed a dose of 200 mg/day. The duration of the treatment for each participant was planned to be at least 3 years, until BRV received approval for pediatric participants in their age range or until the IMP development was stopped by the Sponsor.
All-Cause Mortality
	Age Cohort: ≥1 Month to <2 Years		Age Cohort: ≥2 to <4 Years		Age Cohort: ≥4 to <12 Years		Age Cohort: ≥12 to <17 Years
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	2/36 (5.56%)		2/15 (13.33%)		2/141 (1.42%)		1/65 (1.54%)
Serious Adverse Events
	Age Cohort: ≥1 Month to <2 Years		Age Cohort: ≥2 to <4 Years		Age Cohort: ≥4 to <12 Years		Age Cohort: ≥12 to <17 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/36 (38.89%)		8/15 (53.33%)		42/141 (29.79%)		19/65 (29.23%)
Blood and lymphatic system disorders
Anaemia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Immune thrombocytopenic purpura * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Neutropenia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Thrombocytopenia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Congenital, familial and genetic disorders
Cryptorchism * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Developmental hip dysplasia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Spina bifida * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Phimosis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Ear and labyrinth disorders
Deafness neurosensory * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Gastrointestinal disorders
Vomiting * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	3/141 (2.13%)	3	0/65 (0.00%)	0
Gastrooesophageal reflux disease * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Dysphagia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Faecaloma * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Gastritis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Stomatitis * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Tooth deposit * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Toothache * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Volvulus * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
General disorders
Pyrexia * 1	2/36 (5.56%)	3	1/15 (6.67%)	1	3/141 (2.13%)	3	0/65 (0.00%)	0
Asthenia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hypothermia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Inflammation * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Device extrusion * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Immune system disorders
Hypersensitivity * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Infections and infestations
Pneumonia * 1	3/36 (8.33%)	6	0/15 (0.00%)	0	4/141 (2.84%)	11	1/65 (1.54%)	1
Gastroenteritis * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	3/141 (2.13%)	3	0/65 (0.00%)	0
Bronchitis * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Septic shock * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	2/141 (1.42%)	2	0/65 (0.00%)	0
Upper respiratory tract infection * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	2/141 (1.42%)	2	0/65 (0.00%)	0
Urinary tract infection * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Viral infection * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Appendicitis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Clostridium difficile colitis * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Corona virus infection * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Epididymitis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Neurocysticercosis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Periorbital cellulitis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Pharyngitis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Respiratory syncytial virus infection * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Respiratory tract infection * 1	0/36 (0.00%)	0	1/15 (6.67%)	2	0/141 (0.00%)	0	0/65 (0.00%)	0
Tuberculosis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Viral upper respiratory tract infection * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Injury, poisoning and procedural complications
Clavicle fracture * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Greenstick fracture * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Iatrogenic injury * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Toxicity to various agents * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Procedural pain * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Upper limb fracture * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Investigations
Blood bicarbonate decreased * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Hepatic enzyme increased * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Laparoscopy * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Weight decreased * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Metabolism and nutrition disorders
Dehydration * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	3/141 (2.13%)	3	1/65 (1.54%)	1
Decreased appetite * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hyperammonaemia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hypoglycaemia * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Hyponatraemia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Underweight * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	2	0/65 (0.00%)	0
Scoliosis * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma, low grade * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Nervous system disorders
Seizure * 1	1/36 (2.78%)	6	1/15 (6.67%)	1	12/141 (8.51%)	20	2/65 (3.08%)	2
Status epilepticus * 1	2/36 (5.56%)	3	0/15 (0.00%)	0	7/141 (4.96%)	12	2/65 (3.08%)	3
Epilepsy * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	4/141 (2.84%)	7	0/65 (0.00%)	0
Generalised tonic-clonic seizure * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	2/141 (1.42%)	2	1/65 (1.54%)	1
Somnolence * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	3/141 (2.13%)	4	1/65 (1.54%)	1
Complex partial seizures * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Partial seizures with secondary generalisation * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	1/65 (1.54%)	2
Simple partial seizures * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Ataxia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Headache * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hydrocephalus * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Loss of consciousness * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Petit mal epilepsy * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Subdural hygroma * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Pregnancy, puerperium and perinatal conditions
Pregnancy * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Psychiatric disorders
Suicidal ideation * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	2/65 (3.08%)	2
Affect lability * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Aggression * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Anger * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Depression * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Homicidal ideation * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Suicide attempt * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Renal and urinary disorders
Chronic kidney disease * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hydronephrosis * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Renal tubular acidosis * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Reproductive system and breast disorders
Testicular torsion * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Asthma * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Bronchospasm * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Pneumonia aspiration * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Respiratory distress * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	2/141 (1.42%)	3	0/65 (0.00%)	0
Respiratory failure * 1	0/36 (0.00%)	0	1/15 (6.67%)	2	0/141 (0.00%)	0	1/65 (1.54%)	1
Acute respiratory failure * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Apnoea * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Aspiration * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Asthmatic crisis * 1	1/36 (2.78%)	2	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Chronic respiratory failure * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hypoxia * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Sleep apnoea syndrome * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Skin and subcutaneous tissue disorders
Skin reaction * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Surgical and medical procedures
Brain operation * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Gastrostomy * 1	1/36 (2.78%)	2	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Osteotomy * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Vascular disorders
Circulatory collapse * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Haemodynamic instability * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
1 Term from vocabulary, MedDRA 18.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Age Cohort: ≥1 Month to <2 Years		Age Cohort: ≥2 to <4 Years		Age Cohort: ≥4 to <12 Years		Age Cohort: ≥12 to <17 Years
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/36 (83.33%)		13/15 (86.67%)		120/141 (85.11%)		51/65 (78.46%)
Blood and lymphatic system disorders
Anaemia * 1	3/36 (8.33%)	5	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	2
Cardiac disorders
Atrioventricular block first degree * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Congenital, familial and genetic disorders
Arnold-Chiari malformation * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Ear and labyrinth disorders
Ear pain * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	6/141 (4.26%)	6	0/65 (0.00%)	0
Endocrine disorders
Hypothyroidism * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	6/141 (4.26%)	6	1/65 (1.54%)	1
Eye disorders
Strabismus * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Eyelid oedema * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Hypermetropia * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Gastrointestinal disorders
Vomiting * 1	11/36 (30.56%)	19	5/15 (33.33%)	6	34/141 (24.11%)	61	4/65 (6.15%)	4
Diarrhoea * 1	7/36 (19.44%)	16	0/15 (0.00%)	0	21/141 (14.89%)	33	8/65 (12.31%)	8
Abdominal pain * 1	4/36 (11.11%)	4	0/15 (0.00%)	0	12/141 (8.51%)	20	3/65 (4.62%)	9
Constipation * 1	7/36 (19.44%)	11	0/15 (0.00%)	0	10/141 (7.09%)	12	2/65 (3.08%)	4
Abdominal pain upper * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	9/141 (6.38%)	10	8/65 (12.31%)	10
Nausea * 1	4/36 (11.11%)	4	0/15 (0.00%)	0	5/141 (3.55%)	5	3/65 (4.62%)	3
Gastrooesophageal reflux disease * 1	5/36 (13.89%)	6	1/15 (6.67%)	1	4/141 (2.84%)	5	0/65 (0.00%)	0
Toothache * 1	1/36 (2.78%)	21	1/15 (6.67%)	1	5/141 (3.55%)	5	1/65 (1.54%)	1
Abdominal distension * 1	3/36 (8.33%)	5	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Dysphagia * 1	1/36 (2.78%)	1	1/15 (6.67%)	3	1/141 (0.71%)	1	0/65 (0.00%)	0
Enteritis * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	0/141 (0.00%)	0	1/65 (1.54%)	1
Teething * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Hiatus hernia * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
General disorders
Device occlusion * 1	2/36 (5.56%)	3	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Fatigue * 1	1/36 (2.78%)	1	2/15 (13.33%)	3	5/141 (3.55%)	6	6/65 (9.23%)	10
Gait disturbance * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	1/141 (0.71%)	2	0/65 (0.00%)	0
Pyrexia * 1	15/36 (41.67%)	84	4/15 (26.67%)	11	37/141 (26.24%)	63	7/65 (10.77%)	9
Influenza like illness * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Oedema peripheral * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Immune system disorders
Hypersensitivity * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	2/141 (1.42%)	3	0/65 (0.00%)	0
Infections and infestations
Pharyngitis * 1	10/36 (27.78%)	21	2/15 (13.33%)	9	39/141 (27.66%)	60	8/65 (12.31%)	8
Upper respiratory tract infection * 1	10/36 (27.78%)	19	5/15 (33.33%)	15	23/141 (16.31%)	38	8/65 (12.31%)	12
Pharyngotonsillitis * 1	5/36 (13.89%)	34	0/15 (0.00%)	0	21/141 (14.89%)	64	10/65 (15.38%)	20
Gastroenteritis * 1	8/36 (22.22%)	14	0/15 (0.00%)	0	16/141 (11.35%)	30	5/65 (7.69%)	6
Influenza * 1	5/36 (13.89%)	7	2/15 (13.33%)	2	16/141 (11.35%)	18	6/65 (9.23%)	6
Bronchitis * 1	7/36 (19.44%)	18	3/15 (20.00%)	11	16/141 (11.35%)	29	1/65 (1.54%)	1
Rhinitis * 1	5/36 (13.89%)	8	2/15 (13.33%)	3	16/141 (11.35%)	47	2/65 (3.08%)	6
Nasopharyngitis * 1	11/36 (30.56%)	44	4/15 (26.67%)	6	44/141 (31.21%)	114	16/65 (24.62%)	41
Ear infection * 1	2/36 (5.56%)	3	1/15 (6.67%)	2	10/141 (7.09%)	18	4/65 (6.15%)	4
Tonsillitis * 1	2/36 (5.56%)	2	1/15 (6.67%)	1	13/141 (9.22%)	21	2/65 (3.08%)	3
Otitis media * 1	4/36 (11.11%)	13	1/15 (6.67%)	1	10/141 (7.09%)	24	0/65 (0.00%)	0
Urinary tract infection * 1	2/36 (5.56%)	3	3/15 (20.00%)	3	6/141 (4.26%)	11	4/65 (6.15%)	5
Varicella * 1	4/36 (11.11%)	4	0/15 (0.00%)	0	9/141 (6.38%)	10	0/65 (0.00%)	0
Pharyngitis streptococcal * 1	2/36 (5.56%)	3	0/15 (0.00%)	0	8/141 (5.67%)	9	2/65 (3.08%)	3
Viral infection * 1	3/36 (8.33%)	6	1/15 (6.67%)	1	7/141 (4.96%)	19	1/65 (1.54%)	2
Conjunctivitis * 1	5/36 (13.89%)	6	1/15 (6.67%)	2	4/141 (2.84%)	5	1/65 (1.54%)	1
Respiratory tract infection * 1	3/36 (8.33%)	3	1/15 (6.67%)	37	6/141 (4.26%)	11	1/65 (1.54%)	1
Sinusitis * 1	1/36 (2.78%)	3	2/15 (13.33%)	2	7/141 (4.96%)	12	1/65 (1.54%)	1
Otitis media acute * 1	3/36 (8.33%)	4	0/15 (0.00%)	0	4/141 (2.84%)	5	2/65 (3.08%)	2
Pharyngitis bacterial * 1	2/36 (5.56%)	3	0/15 (0.00%)	0	4/141 (2.84%)	4	1/65 (1.54%)	1
Viral pharyngitis * 1	3/36 (8.33%)	3	0/15 (0.00%)	0	3/141 (2.13%)	3	1/65 (1.54%)	1
Gastroenteritis viral * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	3/141 (2.13%)	3	1/65 (1.54%)	1
Acute sinusitis * 1	0/36 (0.00%)	0	1/15 (6.67%)	2	3/141 (2.13%)	3	0/65 (0.00%)	0
Lice infestation * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	1/141 (0.71%)	1	1/65 (1.54%)	1
Lower respiratory tract infection * 1	3/36 (8.33%)	4	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Hand-foot-and-mouth disease * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Oral candidiasis * 1	2/36 (5.56%)	3	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Bacteraemia * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Gastroenteritis rotavirus * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Oral fungal infection * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Pneumonia * 1	4/36 (11.11%)	4	4/15 (26.67%)	16	9/141 (6.38%)	11	0/65 (0.00%)	0
Injury, poisoning and procedural complications
Laceration * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	4/141 (2.84%)	6	6/65 (9.23%)	10
Fall * 1	1/36 (2.78%)	1	0/15 (0.00%)	0	6/141 (4.26%)	8	8/65 (12.31%)	11
Investigations
Weight decreased * 1	3/36 (8.33%)	3	0/15 (0.00%)	0	10/141 (7.09%)	13	2/65 (3.08%)	2
Gamma-glutamyltransferase increased * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	3/141 (2.13%)	3	1/65 (1.54%)	1
Creatinine renal clearance decreased * 1	2/36 (5.56%)	2	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite * 1	6/36 (16.67%)	7	1/15 (6.67%)	1	16/141 (11.35%)	18	7/65 (10.77%)	8
Metabolic acidosis * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	1/141 (0.71%)	1	1/65 (1.54%)	1
Dehydration * 1	1/36 (2.78%)	2	1/15 (6.67%)	1	0/141 (0.00%)	0	1/65 (1.54%)	1
Hypercholesterolaemia * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Hyperlipidaemia * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Hypernatraemia * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Hyperuricaemia * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Underweight * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Musculoskeletal and connective tissue disorders
Facial asymmetry * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Nervous system disorders
Headache * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	21/141 (14.89%)	58	16/65 (24.62%)	75
Seizure * 1	3/36 (8.33%)	9	2/15 (13.33%)	2	17/141 (12.06%)	29	11/65 (16.92%)	17
Somnolence * 1	3/36 (8.33%)	4	1/15 (6.67%)	1	15/141 (10.64%)	25	5/65 (7.69%)	5
Dizziness * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	7/141 (4.96%)	13	8/65 (12.31%)	16
Complex partial seizures * 1	3/36 (8.33%)	3	0/15 (0.00%)	0	3/141 (2.13%)	3	1/65 (1.54%)	1
Partial seizures with secondary generalisation * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	2/141 (1.42%)	2	1/65 (1.54%)	1
Ataxia * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Hypotonia * 1	1/36 (2.78%)	1	1/15 (6.67%)	2	0/141 (0.00%)	0	0/65 (0.00%)	0
Muscle spasticity * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Psychiatric disorders
Irritability * 1	5/36 (13.89%)	8	0/15 (0.00%)	0	14/141 (9.93%)	15	4/65 (6.15%)	4
Aggression * 1	0/36 (0.00%)	0	2/15 (13.33%)	2	14/141 (9.93%)	18	1/65 (1.54%)	1
Insomnia * 1	2/36 (5.56%)	3	3/15 (20.00%)	3	11/141 (7.80%)	14	0/65 (0.00%)	0
Suicidal ideation * 1	0/36 (0.00%)	0	0/15 (0.00%)	0	5/141 (3.55%)	5	4/65 (6.15%)	4
Anxiety * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	4/141 (2.84%)	5	2/65 (3.08%)	2
Mental status changes * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Hallucination, visual * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Renal and urinary disorders
Urinary incontinence * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	3/141 (2.13%)	10	0/65 (0.00%)	0
Neurogenic bladder * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough * 1	6/36 (16.67%)	8	2/15 (13.33%)	4	19/141 (13.48%)	26	5/65 (7.69%)	8
Oropharyngeal pain * 1	0/36 (0.00%)	0	2/15 (13.33%)	2	6/141 (4.26%)	7	5/65 (7.69%)	7
Rhinitis allergic * 1	2/36 (5.56%)	5	0/15 (0.00%)	0	10/141 (7.09%)	11	0/65 (0.00%)	0
Epistaxis * 1	2/36 (5.56%)	2	1/15 (6.67%)	1	6/141 (4.26%)	8	2/65 (3.08%)	2
Rhinorrhoea * 1	4/36 (11.11%)	18	0/15 (0.00%)	0	3/141 (2.13%)	4	1/65 (1.54%)	1
Asthma * 1	3/36 (8.33%)	5	2/15 (13.33%)	2	0/141 (0.00%)	0	0/65 (0.00%)	0
Nasal congestion * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	2/141 (1.42%)	3	1/65 (1.54%)	1
Adenoidal hypertrophy * 1	3/36 (8.33%)	3	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Asthmatic crisis * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	1/141 (0.71%)	1	0/65 (0.00%)	0
Bronchospasm * 1	2/36 (5.56%)	5	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Aspiration * 1	0/36 (0.00%)	0	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash * 1	2/36 (5.56%)	2	0/15 (0.00%)	0	10/141 (7.09%)	15	1/65 (1.54%)	1
Dermatitis contact * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	1/141 (0.71%)	1	1/65 (1.54%)	1
Dermatitis diaper * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	1/141 (0.71%)	1	0/65 (0.00%)	0
Alopecia * 1	2/36 (5.56%)	3	0/15 (0.00%)	0	0/141 (0.00%)	0	0/65 (0.00%)	0
Hair growth abnormal * 1	0/36 (0.00%)	0	1/15 (6.67%)	2	0/141 (0.00%)	0	0/65 (0.00%)	0
Vascular disorders
Hypotension * 1	1/36 (2.78%)	1	1/15 (6.67%)	1	0/141 (0.00%)	0	0/65 (0.00%)	0
1 Term from vocabulary, MedDRA 18.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: UCB
• Organization: Cares
• Phone: 001 844 599 2273
• EMail: UCBCares@ucb.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

• Responsible Party: UCB Pharma ( UCB Pharma SA )
• ClinicalTrials.gov Identifier: NCT01364597
• Other Study ID Numbers: N01266; 2011-000374-60 ( EudraCT Number )
• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Results First Submitted: August 1, 2022
• Results First Posted: August 29, 2022
• Last Update Posted: November 14, 2022