Trial Outcomes & Findings for A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age (NCT NCT03340064)
NCT ID: NCT03340064
Last Updated: 2024-07-23
Results Overview
The percent difference in partial seizure frequency per week at Baseline and Study Visit 6 (Week 6) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 6)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
38 participants
Primary outcome timeframe
From Baseline (Week 0) to Visit 6 (up to Week 6)
Results posted on
2024-07-23
Participant Flow
The study started to enroll participants in November 2017 and concluded in July 2023.
Participant Flow refers to the Safety Set Adjunctive therapy (SS\_A) and Safety Set Monotherapy (SS\_M).
Participant milestones
| Measure |
Levetiracetam: Adjunctive Therapy
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
First Period
STARTED
|
32
|
6
|
|
First Period
COMPLETED
|
27
|
6
|
|
First Period
NOT COMPLETED
|
5
|
0
|
|
Second Period
STARTED
|
27
|
6
|
|
Second Period
COMPLETED
|
8
|
4
|
|
Second Period
NOT COMPLETED
|
19
|
2
|
Reasons for withdrawal
| Measure |
Levetiracetam: Adjunctive Therapy
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
First Period
Adverse Event, non-fatal
|
2
|
0
|
|
First Period
Lack of Efficacy
|
3
|
0
|
|
Second Period
Adverse Event, non-fatal
|
1
|
1
|
|
Second Period
Lack of Efficacy
|
11
|
0
|
|
Second Period
Physician Decision
|
3
|
0
|
|
Second Period
Withdrawal by Subject
|
2
|
1
|
|
Second Period
Approved Drug Available For Indication
|
1
|
0
|
|
Second Period
Protocol-Specified Withdrawal Criterion Met
|
1
|
0
|
Baseline Characteristics
A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
Baseline characteristics by cohort
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.7 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
32.4 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
17.5 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Age, Customized
28 days - <24 months
|
26 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
24 months - <12 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japan
|
32 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Week 0) to Visit 6 (up to Week 6)Population: The Full Analysis Set Adjunctive therapy (FAS\_A) consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
The percent difference in partial seizure frequency per week at Baseline and Study Visit 6 (Week 6) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 6)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=28 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 6
|
24.24 percent change
Interval -25.48 to 51.85
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to Visit 4 (up to Week 2)Population: The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment.
The percent difference in partial seizure frequency per week at Baseline and Study Visit 4 (Week 2) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 4)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 4
|
8.62 percent change
Interval -343.1 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to Visit 5 (up to Week 4)Population: The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment.
The percent difference in partial seizure frequency per week at Baseline and Study Visit 5 (Week 4) was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at Study Visit 5)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on adjunctive therapy.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percent Change in Partial Seizure Frequency Per Week From Baseline to Visit 5
|
16.79 percent change
Interval -414.3 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0), Week 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV (up to Week 295), and Safety follow-up (up to Week 295)Population: The FAS\_A consisted of all participants in the SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Here, number analyzed signifies participants who were evaluable at specified time points.
Percent difference in partial seizure frequency (PSF) per week at each Analysis Visit: {\[(Number of partial seizures per week at Baseline \[BL\]) - (Number of partial seizures per week at analysis visit X)\]/(Number of partial seizures per week at BL)}\*100. Positive value indicates reduction in PSF from BL. End of study (EOS)/early discontinuation visit (EDV) was based on last EDV and calculation of number of partial seizure per week were based on the period from the previous EDV visit. The mapping of seizure data to Analysis Visits was based on target dates of the visits. A seizure date after that of target date of an Analysis Visit n and up to that of target date of next Analysis Visit n+1 was mapped to the next Analysis Visit (n+1). Data for one participant assessed within study duration was mapped to Analysis Visit 35/Week 300 based on statistical plan.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=25 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 72
|
100.00 percent change
Interval 32.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 168
|
99.74 percent change
Interval 90.7 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 8
|
35.53 percent change
Interval -137.9 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 10
|
59.39 percent change
Interval -138.2 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 12
|
50.90 percent change
Interval -167.8 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 15
|
60.29 percent change
Interval -129.4 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 18
|
82.74 percent change
Interval -22.3 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 21
|
80.33 percent change
Interval -44.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 24
|
88.44 percent change
Interval -97.8 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 27
|
93.84 percent change
Interval -4.8 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 30
|
98.05 percent change
Interval -4.8 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 36
|
100.00 percent change
Interval -94.5 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 48
|
98.70 percent change
Interval -28.4 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 60
|
100.00 percent change
Interval 44.7 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 84
|
100.00 percent change
Interval 62.9 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 96
|
99.57 percent change
Interval 78.2 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 108
|
100.00 percent change
Interval -48.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 120
|
100.00 percent change
Interval 80.4 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 132
|
100.00 percent change
Interval 50.7 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 144
|
100.00 percent change
Interval 93.4 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 156
|
99.76 percent change
Interval 93.5 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 180
|
99.02 percent change
Interval 86.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 192
|
99.76 percent change
Interval 85.5 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 204
|
97.94 percent change
Interval 78.3 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 216
|
96.58 percent change
Interval 81.4 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 228
|
97.12 percent change
Interval 96.6 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 240
|
96.36 percent change
Interval 86.8 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 252
|
91.12 percent change
Interval 85.3 to 96.9
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 264
|
96.91 percent change
Interval 95.8 to 98.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 276
|
96.40 percent change
Interval 95.2 to 97.6
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 288
|
96.14 percent change
Interval 94.2 to 98.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Week 300
|
89.7 percent change
Interval 89.7 to 89.7
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
EOS/EDV
|
21.86 percent change
Interval -120.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Adjunctive Therapy
Safety Follow Up
|
39.82 percent change
Interval -267.8 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, EOS/EDV Week 2, EOS/EDV Week 4, and Safety follow-up (up to Week 295)Population: FAS\_A consisted of all participants in SS\_A who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were at risk at each previous analysis visit (X-1). As per planned analysis, outcome categories "≥50%", "≥75%" and "100%" are overlapping, so that percentages of categories of this outcome measure can add up to more than 100%. Data for one participant assessed within study duration was mapped to Analysis Visit 35/Week 300 based on statistical plan.
Percent difference in PSF per week on adjunctive therapy at BL and each analysis visit: {\[(Number of partial seizures per week at BL) - (Number of partial seizures per week at analysis visit X)\]/(Number of partial seizures per week at BL)}\*100. Percent difference in PSF per week from Baseline for each participant and analysis visit were mapped into 6 categories: \<0%, 0% to \<25%, 25% to \<50%, ≥50%, ≥75%, and 100%, then percentages of participants in these categories were derived using the number of participants at risk at each previous analysis visit as denominator. Positive value in percent difference from Baseline indicates reduction in PSF from Baseline. The mapping of seizure data to Analysis Visits was based on target dates of visits. A seizure date after that of target date of an Analysis Visit n and up to that of target date of next Analysis Visit n+1 was mapped to next Analysis Visit (n+1).
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 2: 0% - <25%
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 4: 25% - <50%
|
15.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 6: ≥ 50%
|
28.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 8: 25% - <50%
|
17.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 12: <0%
|
20.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 12: ≥ 50%
|
45.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 15: <0%
|
13.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 18: ≥ 50%
|
68.2 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 24: <0%
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 27: 0% - <25%
|
5.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 30: <0%
|
5.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 48: ≥ 50%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 48:100%
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 72: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 72: ≥ 75%
|
76.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 96: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 300: 100%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 6: ≥ 75%
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 6: 100%
|
15.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 8: <0%
|
21.4 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 8: 0% - <25%
|
14.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 8: ≥ 50%
|
35.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 8: ≥ 75%
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 8: 100%
|
17.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 10: <0%
|
24.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 10: 0% - <25%
|
12.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 10: 25% - <50%
|
8.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 10: ≥ 50%
|
52.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 10: ≥ 75%
|
28.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 10: 100%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 12: 0% - <25%
|
4.2 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 12: 25% - <50%
|
20.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 12: ≥ 75%
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 12: 100%
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 15: 0% - <25%
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 15: 25% - <50%
|
13.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 15: ≥ 50%
|
63.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 15: ≥ 75%
|
36.4 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 15: 100%
|
27.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 18: <0%
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 18: 0% - <25%
|
4.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 18: 25% - <50%
|
9.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 18: ≥ 75%
|
54.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 18: 100%
|
31.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 21: <0%
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 21: 0% - <25%
|
5.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 21: 25% - <50%
|
5.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 21: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 21: ≥ 75%
|
55.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 21: 100%
|
30.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 24: 0% - <25%
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 24: 25% - <50%
|
5.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 24: ≥ 50%
|
70.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 24: ≥ 75%
|
55.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 24: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 27: <0%
|
5.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 27: 25% - <50%
|
10.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 27: ≥ 50%
|
73.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 27: ≥ 75%
|
52.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 27: 100%
|
36.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 30: 0% - <25%
|
11.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 30: 25% - <50%
|
5.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 30: ≥ 50%
|
72.2 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 30: ≥ 75%
|
55.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 30: 100%
|
44.4 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 36: <0%
|
11.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 36: 0% - <25%
|
5.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 36: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 36: ≥ 50%
|
76.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 36: ≥ 75%
|
70.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 36: 100%
|
52.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 48: <0%
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 48: 0% - <25%
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 48: 25% - <50%
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 48: ≥ 75%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 60: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 60: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 60: 25% - <50%
|
6.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 60: ≥ 50%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 60: ≥ 75%
|
68.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 60: 100%
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 72: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 72: 25% - <50%
|
7.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 72: ≥ 50%
|
92.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 72: 100%
|
53.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 84: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 84: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 2: <0%
|
43.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 2: 25% - <50%
|
9.4 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 2: ≥ 50%
|
28.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 2: ≥ 75%
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 2: 100%
|
9.4 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 4: <0%
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 4: 0% - <25%
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 4: ≥ 50%
|
28.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 4: ≥ 75%
|
18.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 4: 100%
|
9.4 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 6: <0%
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 6: 0% - <25%
|
15.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 6: 25% - <50%
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 120: ≥ 75%
|
90.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 120: 100%
|
63.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 132: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 132: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 84: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 132: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 252: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 252: ≥ 50%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 252: ≥ 75%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 252: 100%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 264: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 264: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 132: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 264: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 264: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 132: ≥ 75%
|
70.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 264: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 132: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 264: 100%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 276: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 276: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 276: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 276: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 276: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 276: 100%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 288: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 288: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 288: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 288: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 288: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 288: 100%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 300: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 300: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 300: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 300: ≥ 50%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 300: ≥ 75%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 2: <0%
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 2: 0% - <25%
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 2: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 2: ≥ 50%
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 2: ≥ 75%
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 2: 100%
|
3.1 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 4: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 4: 0% - <25%
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 4: 25% - <50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 4: ≥ 50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 4: ≥ 75%
|
10.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 144: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 144: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 144: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 144: ≥ 50%
|
87.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 144: ≥ 75%
|
87.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 144: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 156: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 156: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 156: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 156: ≥ 50%
|
85.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 156: ≥ 75%
|
85.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 156: 100%
|
42.9 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 168: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 168: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 168: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 168: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
EOS/EDV, Week 4: 100%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Safety Follow Up: <0%
|
37.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Safety Follow Up: 0% - <25%
|
4.2 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Safety Follow Up: 25% - <50%
|
12.5 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 168: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 168: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Safety Follow Up: ≥ 50%
|
45.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 180: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 180: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 180: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 180: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 180: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 180: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 192: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 192: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 192: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 192: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 192: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 192: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 204: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 204: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 204: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 204: ≥ 50%
|
83.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 204: ≥ 75%
|
83.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 84: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 204: 100%
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 84: ≥ 75%
|
84.6 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 216: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 216: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 84: 100%
|
53.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 216: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 216: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 216: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 216: 100%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 228: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 228: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 228: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 228: ≥ 50%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 228: ≥ 75%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 228: 100%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 240: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Safety Follow Up: ≥ 75%
|
29.2 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Safety Follow Up: 100%
|
20.8 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 96: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 240: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 240: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 240: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 240: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 240: 100%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 252: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 252: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 96: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 96: ≥ 50%
|
92.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 96: ≥ 75%
|
92.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 96: 100%
|
46.2 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 108: <0%
|
8.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 108: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 108: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 108: ≥ 50%
|
83.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 108: ≥ 75%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 108: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 120: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 120: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 120: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Adjunctive Therapy
Week 120: ≥ 50%
|
90.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295)Population: The FAS\_M consisted of all participants in the SS\_M who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were evaluable at specified time points.
The percent difference in partial seizure frequency per week on monotherapy at Baseline and each analysis visit was computed as: {\[(Number of partial seizures per week at Baseline) minus (Number of partial seizures per week at analysis visit X)\] divided by (Number of partial seizures per week at Baseline)} multiplied by 100. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on monotherapy. The maximum duration of study participation in monotherapy participants was shorter than in adjunctive therapy. Therefore, data at Week 288 and 300 is not reported for Monotherapy.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=6 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 2
|
-51.87 percent change
Interval -731.6 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 4
|
4.88 percent change
Interval -115.9 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 6
|
51.10 percent change
Interval -325.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 8
|
100.00 percent change
Interval -1.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 10
|
100.00 percent change
Interval -277.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 12
|
76.92 percent change
Interval -10.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 15
|
100.00 percent change
Interval -78.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 18
|
91.58 percent change
Interval 58.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 21
|
100.00 percent change
Interval 76.9 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 24
|
100.00 percent change
Interval 92.3 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 27
|
100.00 percent change
Interval 26.7 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 30
|
100.00 percent change
Interval 37.1 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 36
|
100.00 percent change
Interval 16.2 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 48
|
98.08 percent change
Interval -138.3 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 60
|
94.23 percent change
Interval -41.4 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 72
|
92.31 percent change
Interval -36.2 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 84
|
95.79 percent change
Interval -86.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 96
|
98.08 percent change
Interval -65.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 108
|
96.15 percent change
Interval -44.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 120
|
93.68 percent change
Interval -46.7 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 132
|
92.63 percent change
Interval -138.3 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 144
|
92.63 percent change
Interval -106.9 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 156
|
94.73 percent change
Interval 8.3 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 168
|
100.00 percent change
Interval -70.2 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 180
|
100.00 percent change
Interval -274.5 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 192
|
100.00 percent change
Interval -223.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 204
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 216
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 228
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 240
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 252
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 264
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Week 276
|
100.00 percent change
Interval 100.0 to 100.0
|
—
|
|
Percent Change From Baseline for Each Analysis Visit in Partial Seizure Frequency Per Week on Monotherapy
Safety Follow Up
|
100.0 percent change
Interval 100.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0), Week 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, and Safety follow-up (up to Week 295)Population: The FAS\_M consisted of all participants in the SS\_M who had at least 1 post-Baseline efficacy assessment. Here, number analyzed signifies participants who were at risk at each previous analysis visit (X-1). As per planned analysis, outcome categories "≥50%", "≥75%" and "100%" are overlapping, so that percentages of categories of this outcome measure can add up to more than 100%.
Percent difference in PSF per week on monotherapy at BL and each analysis visit: {\[(Number of partial seizures per week at BL) - (Number of partial seizures per week at analysis visit X)\]/(Number of partial seizures per week at BL)}\*100. Percent difference in PFS per week from Baseline for each participant and analysis visit were mapped into 6 categories: \<0%, 0% to \<25%, 25% to \<50%, ≥50%, ≥75%, and 100%, then percentages of participants in these categories were derived using the number of participants at risk at each previous analysis visit as denominator. A positive value in percent difference from Baseline indicates a reduction in partial seizure frequency from Baseline. Data of this outcome measure was analyzed and reported for participants on monotherapy. Maximum duration of study participation in monotherapy participants was shorter than adjunctive therapy. Therefore, data at Week 288 and 300 is not reported for Monotherapy.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=6 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 10: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 12: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 12: ≥ 75%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 18: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 18: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 18: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 21: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 27: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 27: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 30: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 72: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 96: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 120: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 120: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 204: 100%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 216: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Safety Follow Up: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Safety Follow Up: 100%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 27: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 27: 25% - <50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 27: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 27: 100%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 30: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 30: 25% - <50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 30: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 30: ≥ 75%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 30: 100%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 36: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 36: 0% - <25%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 36: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 36: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 36: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 36: 100%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 48: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 48: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 48: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 48: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 48: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 48:100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 60: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 60: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 60: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 60: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 60: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 60: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 72: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 72: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 72: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 72: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 72: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 84: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 84: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 84: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 84: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 84: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 84: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 96: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 96: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 96: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 96: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 96: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 108: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 108: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 108: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 108: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 108: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 108: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 120: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 120: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 120: ≥ 50%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 120: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 132: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 132: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 132: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 132: ≥ 50%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 132: ≥ 75%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 132: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 144: <0%
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 144: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 144: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 144: ≥ 50%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 144: ≥ 75%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 144: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 156: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 2: <0%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 2: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 2: 25% - <50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 2: ≥ 50%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 2: ≥ 75%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 2: 100%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 4: <0%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 4: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 4: 25% - <50%
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 4: ≥ 50%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 4: ≥ 75%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 4: 100%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 6: <0%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 6: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 6: 25% - <50%
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 6: ≥ 50%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 6: ≥ 75%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 6: 100%
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 8: <0%
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 8: 0% - <25%
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 8: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 8: ≥ 50%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 8: ≥ 75%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 8: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 10: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 10: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 10: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 10: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 10: 100%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 12: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 12: 25% - <50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 12: ≥ 50%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 12: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 15: <0%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 15: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 15: 25% - <50%
|
20.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 15: ≥ 50%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 15: ≥ 75%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 15: 100%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 18: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 18: ≥ 75%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 18: 100%
|
40.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 21: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 21: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 21: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 21: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 21: 100%
|
60.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 24: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 24: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 24: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 24: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 24: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 24: 100%
|
80.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 156: 0% - <25%
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 156: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 156: ≥ 50%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 156: ≥ 75%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 156: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 168: <0%
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 168: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 168: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 168: ≥ 50%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 168: ≥ 75%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 168: 100%
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 180: <0%
|
25.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 180: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 180: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 180: ≥ 50%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 180: ≥ 75%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 180: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 192: <0%
|
33.3 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 192: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 192: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 192: ≥ 50%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 192: ≥ 75%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 192: 100%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 204: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 204: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 204: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 204: ≥ 50%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 204: ≥ 75%
|
66.7 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 216: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 216: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 216: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 216: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 216: 100%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 228: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 228: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 228: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 228: ≥ 50%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 228: ≥ 75%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 228: 100%
|
50.0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 240: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 240: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 240: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 240: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 240: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 240: 100%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 252: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 252: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 252: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 252: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 252: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 252: 100%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 264: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 264: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 264: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 264: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 264: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 264: 100%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 276: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 276: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 276: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 276: ≥ 50%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 276: ≥ 75%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Week 276: 100%
|
100 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Safety Follow Up: <0%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Safety Follow Up: 0% - <25%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Safety Follow Up: 25% - <50%
|
0 percentage of participants
|
—
|
|
Percentage of Participants With a Percent Change in Partial Seizure Frequency Per Week of <0%, 0% to <25%, 25% to <50%, ≥50%, ≥75%, or 100% on Monotherapy
Safety Follow Up: ≥ 75%
|
100 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to Visit 6 (up to Week 6)Population: The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation Participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The treatment-emergent adverse events (TEAEs) were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the First Period
|
62.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to Visit 6 (up to Week 6)Population: The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period.
A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that must meet 1 or more of the following criteria: Death; Life-threatening; Significant or persistent disability/incapacity; Congenital anomaly/birth defect (including that occurring in a fetus); Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious; Initial inpatient hospitalization or prolongation of hospitalization. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the First Period
|
9.4 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to Visit 6 (up to Week 6)Population: The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs leading to discontinuation from study medication are reported.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the First Period
|
6.3 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)Population: The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With TEAEs During the Combined First and Second Period
|
96.9 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)Population: The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period.
A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that must meet 1 or more of the following criteria: Death; Life-threatening; Significant or persistent disability/incapacity; Congenital anomaly/birth defect (including that occurring in a fetus); Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or participant and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious; Initial inpatient hospitalization or prolongation of hospitalization. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent SAEs During the Combined First and Second Period
|
56.3 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)Population: The SS\_A consisted of all enrolled participants on adjunctive therapy who received at least 1 dose of study medication in the evaluation period. The SS\_M consisted of all enrolled participants on monotherapy who received at least 1 dose of study medication in the evaluation period.
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs leading to discontinuation from study medication are reported.
Outcome measures
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 Participants
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 Participants
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Percentage of Participants With TEAEs Leading to Discontinuation From Study Medication During the Combined First and Second Period
|
9.4 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
Levetiracetam: Adjunctive Therapy
Serious events: 18 serious events
Other events: 28 other events
Deaths: 0 deaths
Levetiracetam: Monotherapy
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 participants at risk
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 participants at risk
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Cryptorchism
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Pneumonia viral
|
9.4%
3/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Bronchitis
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Bronchitis viral
|
3.1%
1/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Coronavirus infection
|
3.1%
1/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Cellulitis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Gastroenteritis norovirus
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Investigations
Blood pressure increased
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Nervous system disorders
Status epilepticus
|
9.4%
3/32 • Number of events 7 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Nervous system disorders
Infantile spasms
|
9.4%
3/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Nervous system disorders
Epilepsy
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Nervous system disorders
Seizure cluster
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Nervous system disorders
Somnolence
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Psychiatric disorders
Selective eating disorder
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Surgical and medical procedures
Epilepsy surgery
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
General disorders
Pyrexia
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Influenza
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
Other adverse events
| Measure |
Levetiracetam: Adjunctive Therapy
n=32 participants at risk
Participants aged 1 month to less than (\<) 6 months received Levetiracetam (LEV) 14 milligram per kilogram per day (mg/kg/day) as adjunctive therapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged greater than or equal to (≥) 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till program discontinued. The dose down-titrated during 4 weeks Interval at the discretion of Investigator.
|
Levetiracetam: Monotherapy
n=6 participants at risk
Participants aged 1 month to \< 6 months received LEV 14 mg/kg/day as monotherapy at Visit 3 (Week 0) of First Period and dose up titrated up to 42 mg/kg/day. Participants aged 6 months to \<4 years received LEV 20 mg/kg/day at Visit 3 (Week 0) of first period and dose up titrated up to a maximum of 60 mg/kg/day up to 6 weeks. The dose was increased by 2 weeks interval as per Investigator's discretion. At Visit 6 (Week 6), dose of participants either down-titrated during 4 weeks interval or they entered in second period and continued LEV 14 to 42 mg/kg/day in participants aged 1 month to \<6 months or LEV 20 to 60 mg/kg/day for participants aged ≥ 6 months \<4 years at the discretion of the Investigator. Participants visited every 4 weeks for the first 6 months of administration and then every 12 weeks thereafter until approval or till the program discontinued. The dose could be down-titrated during 4 weeks Interval at the discretion of Investigator.
|
|---|---|---|
|
Eye disorders
Conjunctivitis allergic
|
9.4%
3/32 • Number of events 4 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
33.3%
2/6 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
8/32 • Number of events 10 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • Number of events 10 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • Number of events 4 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Dental caries
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
General disorders
Pyrexia
|
37.5%
12/32 • Number of events 51 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
33.3%
2/6 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Immune system disorders
Food allergy
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Nasopharyngitis
|
53.1%
17/32 • Number of events 108 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
83.3%
5/6 • Number of events 21 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Gastroenteritis
|
21.9%
7/32 • Number of events 11 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
33.3%
2/6 • Number of events 4 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Conjunctivitis
|
18.8%
6/32 • Number of events 16 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Influenza
|
15.6%
5/32 • Number of events 6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Exanthema subitum
|
15.6%
5/32 • Number of events 5 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
12.5%
4/32 • Number of events 5 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Otitis media
|
9.4%
3/32 • Number of events 5 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
COVID-19
|
9.4%
3/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
9.4%
3/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
50.0%
3/6 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Hordeolum
|
6.2%
2/32 • Number of events 4 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Coronavirus infection
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Molluscum contagiosum
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Impetigo
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Pharyngitis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Tonsillitis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Cystitis
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
9.4%
3/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.2%
2/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Investigations
Glucose urine present
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Nervous system disorders
Somnolence
|
18.8%
6/32 • Number of events 7 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Psychiatric disorders
Agitation
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Psychiatric disorders
Irritability
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
9.4%
3/32 • Number of events 8 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
33.3%
2/6 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 7 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
9.4%
3/32 • Number of events 4 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
33.3%
2/6 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
50.0%
3/6 • Number of events 4 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
28.1%
9/32 • Number of events 16 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
12.5%
4/32 • Number of events 9 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
2/32 • Number of events 3 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Number of events 2 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
0.00%
0/6 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
3.1%
1/32 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
|
Skin and subcutaneous tissue disorders
Urticaria thermal
|
0.00%
0/32 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
16.7%
1/6 • Number of events 1 • From Baseline (Week 0) to the End of Safety Follow-up (up to Week 295)
TEAEs were defined as those events that started on or after the date (and time) of first dose of study medication, or adverse events whose intensity worsened on or after the date (and time) of first dose of study medication. TEAEs were analyzed and reported for SS\_A and SS\_M.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60