Trial Outcomes & Findings for Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs (NCT NCT01527006)
NCT ID: NCT01527006
Last Updated: 2016-07-12
Results Overview
CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
From Day 8 up to Day 78
Results posted on
2016-07-12
Participant Flow
Of the 63 participants who were enrolled, 13 participants were screen failures and 50 participants were eligible to continue in the Core Study. Of the 42 subjects who completed the Core Study, 41 subjects continued into the Extension Phase.
Participant milestones
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age)
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age)
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|
|
Core Study
STARTED
|
22
|
28
|
|
Core Study
COMPLETED
|
20
|
22
|
|
Core Study
NOT COMPLETED
|
2
|
6
|
|
Extension Phase
STARTED
|
19
|
22
|
|
Extension Phase
COMPLETED
|
13
|
14
|
|
Extension Phase
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age)
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age)
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|
|
Core Study
Adverse Event
|
0
|
2
|
|
Core Study
Lost to Follow-up
|
0
|
1
|
|
Core Study
Subject Choice
|
1
|
0
|
|
Core Study
Inadequate Therapeutic Effect
|
1
|
0
|
|
Core Study
Withdrawal by Subject
|
0
|
1
|
|
Core Study
Other
|
0
|
2
|
|
Extension Phase
Adverse Event
|
4
|
2
|
|
Extension Phase
Lost to Follow-up
|
0
|
1
|
|
Extension Phase
Subject Choice
|
1
|
1
|
|
Extension Phase
Inadequate therapeutic effect
|
1
|
1
|
|
Extension Phase
Other
|
0
|
3
|
Baseline Characteristics
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
Baseline characteristics by cohort
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=28 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5 Years
n=99 Participants
|
9 Years
n=107 Participants
|
7.5 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Day 8 up to Day 78Population: The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.
CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=20 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Apparent Clearance (CL/F) of Perampanel [Core Study]
Non-Inducers (N=14, 12)
|
0.732 Liter per hour
Standard Deviation 0.374
|
0.956 Liter per hour
Standard Deviation 0.4
|
—
|
—
|
|
Apparent Clearance (CL/F) of Perampanel [Core Study]
Inducers (N=6, 10)
|
1.73 Liter per hour
Standard Deviation 1.18
|
1.92 Liter per hour
Standard Deviation 0.517
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 8 up to Day 78Population: The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.
C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F \[L/h\]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=20 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]
Non-Inducers (N=14, 12)
|
179 ng/mL
Standard Deviation 110
|
266 ng/mL
Standard Deviation 220
|
—
|
—
|
|
Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]
Inducers (N=6, 10)
|
96.8 ng/mL
Standard Deviation 90.4
|
105 ng/mL
Standard Deviation 38.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15Population: The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=28 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]
Overall seizures
|
-43.6 Percent change
Interval -100.0 to 95.4
|
-33.9 Percent change
Interval -100.0 to 1038.9
|
—
|
—
|
|
Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]
Overall partial seizures
|
-82.5 Percent change
Interval -100.0 to 95.4
|
-46.8 Percent change
Interval -100.0 to 1722.2
|
—
|
—
|
|
Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]
Overall generalized seizures
|
-53.1 Percent change
Interval -100.0 to 188.7
|
305.4 Percent change
Interval -62.9 to 1277.3
|
—
|
—
|
|
Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]
Unclassified Seizures
|
-73.7 Percent change
Interval -100.0 to 217.3
|
-67.3 Percent change
Interval -100.0 to -34.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11Population: The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline \[2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase\] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=28 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
50% Responder Rate During the Maintenance Period-LOCF [Core Study]
Overall seizures
|
72.7 Percent responders
|
53.8 Percent responders
|
—
|
—
|
|
50% Responder Rate During the Maintenance Period-LOCF [Core Study]
Overall partial seizures
|
82.4 Percent responders
|
60.9 Percent responders
|
—
|
—
|
|
50% Responder Rate During the Maintenance Period-LOCF [Core Study]
Overall generalized seizures
|
76.9 Percent responders
|
33.3 Percent responders
|
—
|
—
|
|
50% Responder Rate During the Maintenance Period-LOCF [Core Study]
Unclassified Seizures
|
66.7 Percent responders
|
100 Percent responders
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9 to Week 11Population: The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=20 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Overall Seizures
|
15 Percentage of participants
|
27.3 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Simple Partial without Motor Signs
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Simple Partial with Motor signs
|
80 Percentage of participants
|
95.5 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Complex Partial
|
80 Percentage of participants
|
50 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Partial Seizures with SG
|
75 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Overall Partial Seizures
|
50 Percentage of participants
|
45.5 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Absence Generalized
|
95 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Myoclonic Generalized
|
80 Percentage of participants
|
86.4 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Clonic Generalized
|
100 Percentage of participants
|
100 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Tonic Generalized
|
85 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Tonic Clonic Generalized
|
80 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Atonic Generalized
|
95 Percentage of participants
|
95.5 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Overall Generalized seizures
|
55 Percentage of participants
|
77.3 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Maintenance Period [Core Study]
Unclassified Seizures
|
100 Percentage of participants
|
95.5 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 11 or EOTPopulation: The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.
The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0).
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=27 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Normal, not at all ill (N=22, 27)
|
6 Participants
|
5 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Borderline mentally ill (N=22, 27)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Mildly ill (N=22, 27)
|
3 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Moderately ill (N=22,27)
|
10 Participants
|
11 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Markedly ill (N=22, 27)
|
3 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Severely ill (N=22, 27)
|
0 Participants
|
3 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
Baseline - Extremely ill (N=22, 27)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - Very much improved (N=22, 25)
|
6 Participants
|
7 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - Much improved (N=22, 25)
|
8 Participants
|
8 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - Minimally improved (N=22, 25)
|
5 Participants
|
5 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - No Change (N=22, 25)
|
2 Participants
|
3 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - Minimally worse (N=22, 25)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - Much worse (N=22, 25)
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]
EOT - Very much worse (N=22, 25)
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension PhasePopulation: The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=28 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
n=19 Participants
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
n=22 Participants
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Treatment Emergent Non-Serious AEs
|
22 Participants
|
25 Participants
|
19 Participants
|
22 Participants
|
|
Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel
Treatment Emergent SAEs
|
3 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Week 5 or at the time of early discontinuationPopulation: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=13 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
Very good
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
Not good, not bad
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
Bad
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
Very bad
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]
Good
|
6 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 5 or at the time of early discontinuationPopulation: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=13 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
Very good
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
Good
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
Not good, not bad
|
7 Participants
|
13 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
Bad
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]
Very bad
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 5 or at the time of early discontinuationPopulation: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult).
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=14 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]
Very easy
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]
Easy
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]
Neither easy or difficult
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]
Difficult
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]
Very Difficult
|
0 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 5 or at the time of early discontinuationPopulation: The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.
The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind).
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=15 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]
Yes
|
4 Participants
|
9 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]
No
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]
Don't mind
|
9 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 1-13
|
-58.74 Percent change
Interval -100.0 to 75.8
|
-39.59 Percent change
Interval -100.0 to 759.3
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 14-26
|
-76.89 Percent change
Interval -100.0 to 134.4
|
-39.19 Percent change
Interval -100.0 to 389.8
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 27-39; N=18, 20
|
-80.93 Percent change
Interval -100.0 to 129.9
|
-45.60 Percent change
Interval -100.0 to 474.6
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 40-52; N=15, 15
|
-77.58 Percent change
Interval -100.0 to -1.2
|
-47.25 Percent change
Interval -100.0 to 200.0
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 1-13; N=14,19
|
-79.62 Percent change
Interval -100.0 to 75.8
|
-56.04 Percent change
Interval -100.0 to 290.5
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 14-26; N=14, 19
|
-78.69 Percent change
Interval -100.0 to 134.4
|
-67.30 Percent change
Interval -100.0 to 87.9
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 27-39; N=14, 17
|
-89.49 Percent change
Interval -100.0 to 129.9
|
-53.57 Percent change
Interval -100.0 to 165.2
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 40-52; N=14, 14
|
-89.89 Percent change
Interval -100.0 to -1.2
|
-39.46 Percent change
Interval -100.0 to 100.0
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 1-13; N=11, 6
|
-63.96 Percent change
Interval -100.0 to 465.5
|
177.58 Percent change
Interval -65.0 to 1065.4
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 14-26; N=11, 6
|
-79.08 Percent change
Interval -100.0 to 440.7
|
-14.13 Percent change
Interval -87.3 to 389.8
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 27-39; N=10, 6
|
-73.93 Percent change
Interval -100.0 to -8.9
|
-4.77 Percent change
Interval -83.6 to 474.6
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 40-52; N=7, 3
|
-76.91 Percent change
Interval -100.0 to 182.8
|
-5.86 Percent change
Interval -61.5 to 700.0
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1
|
-88.74 Percent change
Interval -100.0 to 77.5
|
-41.61 Percent change
Interval -41.61 to -41.61
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 14-26; N=2,1
|
-100.0 Percent change
Interval -100.0 to -100.0
|
-21.07 Percent change
Interval -21.07 to -21.07
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 27-39; N=2,1
|
-58.24 Percent change
Interval -100.0 to -16.5
|
6.81 Percent change
Interval 6.81 to 6.81
|
—
|
—
|
|
Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 40-52; N=2,1
|
-100.0 Percent change
Interval -100.0 to -100.0
|
-73.21 Percent change
Interval -73.21 to -73.21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 1-13
|
57.9 Percentage of responders
|
45.5 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 14-26
|
84.2 Percentage of responders
|
45.5 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 27-39; N=18, 20
|
77.8 Percentage of responders
|
45.0 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Seizures- Weeks 40-52; N=15, 15
|
80.0 Percentage of responders
|
46.7 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 1-13; N=14,19
|
64.3 Percentage of responders
|
57.9 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 14-26; N=14, 19
|
85.7 Percentage of responders
|
57.9 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 27-39; N=14, 17
|
92.9 Percentage of responders
|
52.9 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Partial Seizures- Weeks 40-52; N=14, 14
|
71.4 Percentage of responders
|
42.9 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 1-13; N=11, 6
|
72.7 Percentage of responders
|
16.7 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 14-26; N=11, 6
|
81.8 Percentage of responders
|
33.3 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 27-39; N=10, 6
|
70.0 Percentage of responders
|
16.7 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Overall Generalized Seizures- Weeks 40-52; N=7, 3
|
71.4 Percentage of responders
|
33.3 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 1-13; N=2, 1
|
100.0 Percentage of responders
|
0.0 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 14-26; N=2,1
|
100.0 Percentage of responders
|
0.0 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 27-39; N=2,1
|
50.0 Percentage of responders
|
0.0 Percentage of responders
|
—
|
—
|
|
50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]
Unclassified Epileptic Seizure- Weeks 40-52; N=2,1
|
100.0 Percentage of responders
|
100.0 Percentage of responders
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52Population: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants.
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Seizures- Weeks 1-13
|
21.1 Percentage of participants
|
22.7 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Seizures- Weeks 14-26;N=18, 20
|
22.2 Percentage of participants
|
30.0 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Seizures- Weeks 27-39; N=15, 15
|
13.3 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Seizures- Weeks 40-52; N=11, 11
|
27.3 Percentage of participants
|
36.4 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Partial Seizures- Weeks 1-13
|
52.6 Percentage of participants
|
40.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Partial Seizures- Weeks 14-26; N=18, 20
|
55.6 Percentage of participants
|
45.0 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Partial Seizures- Weeks 27-39; N=15, 15
|
33.3 Percentage of participants
|
40.0 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Partial Seizures- Weeks 40-52; N=11, 11
|
36.4 Percentage of participants
|
45.5 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Generalized Seizures- Weeks 1-13
|
57.9 Percentage of participants
|
72.7 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Generalized Seizures- Weeks 14-26; N=18,20
|
55.6 Percentage of participants
|
75.0 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Generalized Seizures- Weeks 27-39; N=15,15
|
66.7 Percentage of participants
|
80.0 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Overall Generalized Seizures- Weeks 40-52; N=11,11
|
63.6 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Unclassified Epileptic Seizure- Weeks 1-13
|
100.0 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Unclassified Epileptic Seizure-Weeks 14-26;N=18,20
|
100.0 Percentage of participants
|
95.0 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Unclassified Epileptic Seizure-Weeks 27-39;N=15,15
|
93.3 Percentage of participants
|
93.3 Percentage of participants
|
—
|
—
|
|
Seizure-free Rate During the Overall Treatment Duration [Extension Phase]
Unclassified Epileptic Seizure-Weeks 40-52;N=11,11
|
100.0 Percentage of participants
|
90.9 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0 (Baseline), Week 11, Week 28, Week 52 or EOTPopulation: The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.
The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0).
Outcome measures
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=19 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=22 Participants
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Normal, not at all ill
|
5 Participants
|
3 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Borderline mentally ill
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Mildly ill
|
3 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Moderately ill
|
10 Participants
|
10 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Markedly ill
|
1 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Severely ill
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Baseline- Extremely ill
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- Very much improved; N=19, 21
|
6 Participants
|
7 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- Much improved; N=19, 21
|
8 Participants
|
7 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- Minimally improved; N=19, 21
|
3 Participants
|
5 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- No change; N= 19, 21
|
2 Participants
|
2 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- Minimally worse; N=19, 21
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- Much worse; N=19, 21
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 11- Very much worse; N=19, 21
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- Very much improved; N=18, 19
|
5 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- Much improved; N=18, 19
|
7 Participants
|
8 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- Minimally improved; N=18, 19
|
2 Participants
|
3 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- No change; N=18, 19
|
4 Participants
|
3 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- Minimally worse; N=18, 19
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- Much worse; N=18, 19
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 28- Very much worse; N=18, 19
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- Very much improved; N=14, 12
|
1 Participants
|
3 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- Much improved; N=14, 12
|
7 Participants
|
5 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- Minimally improved; N=14, 12
|
4 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- No change; N=14, 12
|
1 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- Minimally worse; N=14, 12
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- Much worse; N=14, 12
|
1 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
Week 52- Very much worse; N=14, 12
|
0 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- Very much improved
|
1 Participants
|
4 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- Much improved
|
8 Participants
|
9 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- Minimally improved
|
5 Participants
|
6 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- No change
|
4 Participants
|
2 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- Minimally worse
|
0 Participants
|
1 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- Much worse
|
1 Participants
|
0 Participants
|
—
|
—
|
|
The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]
EOT- Very much worse
|
0 Participants
|
0 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 weeksPopulation: This outcome was not assessed in the study.
This outcome was not assessed in the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 weeksPopulation: This outcome was not assessed in the study.
This outcome was not assessed in the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 weeksPopulation: This outcome was not assessed in the study.
This outcome was not assessed in the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 weeksPopulation: This outcome was not assessed in the study.
This outcome was not assessed in the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 weeksPopulation: This outcome was not assessed in the study.
This outcome was not assessed in the study.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 11 weeksPopulation: This outcome was not assessed in the study.
This outcome was not assessed in the study.
Outcome measures
Outcome data not reported
Adverse Events
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 participants at risk
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=28 participants at risk
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
n=19 participants at risk
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
n=22 participants at risk
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Developmental Hip Dysplasia
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Otitis Media Acute
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Mental Status Changes
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Cyclic Vomiting Syndrome
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Anticonvulsant Drug Level Increased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
Other adverse events
| Measure |
Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study
n=22 participants at risk
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study
n=28 participants at risk
During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
|
Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase
n=19 participants at risk
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase
n=22 participants at risk
During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
14.3%
4/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
22.7%
5/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
17.9%
5/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
21.1%
4/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
27.3%
6/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
General disorders
Fatigue
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
28.6%
8/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
27.3%
6/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
General disorders
Gait Disturbance
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
General disorders
Irritability
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
17.9%
5/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
22.7%
5/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
General disorders
Pyrexia
|
36.4%
8/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
14.3%
4/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
42.1%
8/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
31.8%
7/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Ear Infection
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
18.2%
4/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Otitis Media
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
26.3%
5/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
27.3%
6/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Thyroxine Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Weight Increased
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.7%
3/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
18.2%
4/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Increased Aappetite
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.7%
3/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
18.2%
4/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Balance Disorder
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Dizziness
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Lethargy
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
21.1%
4/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Somnolence
|
18.2%
4/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.7%
3/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Tremor
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Aggression
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
26.3%
5/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Oppositional Defiant Disorder
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Tearfulness
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
3.6%
1/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
21.1%
4/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
7.1%
2/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Eye disorders
Eye Irritation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Eye disorders
Photophobia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Aphthous Stomatitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Gingival Recession
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Gastrointestinal disorders
Oral Mucosal Discolouration
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Immune system disorders
Autoimmune Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Influenza
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Lice Infestation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
15.8%
3/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
13.6%
3/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Tinea Capitis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Infections and infestations
Viral Rash
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Injury, poisoning and procedural complications
Epiphyseal Fracture
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Blood Bicarbonate Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Blood Sodium Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Blood Uric Acid Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Cardiac Murmur
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Cardiac Murmur Functional
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Globulins Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Heart Rate Increased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Tri-Iodothyronine Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Investigations
Weight Decreased
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Musculoskeletal and connective tissue disorders
Posture Abnormal
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Drooling
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Intention Tremor
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Sedation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Echolalia
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Emotional Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Reproductive system and breast disorders
Vulval Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Grunting
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
9.1%
2/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
4.5%
1/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
10.5%
2/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/28 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
5.3%
1/19 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
0.00%
0/22 • For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase
Treatment emergent AEs are presented in this section. The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER